Dry Age-related Macular Degeneration, Eye Diseases, Geographic Atrophy, Macular Atrophy, Macular Degeneration, Retinal Degeneration, Retinal Disease
Conditions
Keywords
Dry Age-related Macular Degeneration (Dry AMD), AMD, Atrophic AMD, Geographic Atrophy (GA), Dry-AMD, Dry AMD
Brief summary
This was an open label first in human Phase I/II multicentre study of GT005 in subjects with Macular Atrophy due to Age-related macular degeneration (AMD).
Detailed description
This was an open label first-in-human Phase I/II multicenter study to evaluate the safety, dose response and efficacy of GT005 in participants with Geographic atrophy (GA) due to Age-related macular degeneration (AMD). The study treatment GT005 consists of an Adeno-associated virus serotype 2 (AAV2) expressing human complement factor I (hCFI). The treatment was administered as a single subretinal administration in one eye - the "study eye". Both eyes were assessed at the screening visit. If both eyes meet the eligibility criteria, the study eye will be the worse seeing eye, or the eye with the largest geographic atrophy (GA) lesion area for eyes with equivalent visual acuity, unless the participant (in consultation with the surgeon) expresses an alternative preference. The study was conducted in 4 parts: in Part 1 and Part 2 GT005 was administered subretinally via transvitreal procedure; in Part 3 and 4 GT005 was delivered subretinally via a suprachoroidal cannulation with the Orbit Subretinal delivery system (SDS). The Orbit SDS is a 510(k) cleared device in the US, whereby Parts 3 and 4 were only conducted at US sites. The treatment consisted in 3 dose levels: low dose, 2E10 vector genomes (vg); medium dose, 5E10 vg; and high dose, 2E11 vg. The study consisted of up to 13 visits over a 5-year period. All participants were assessed for the occurrence of treatment emergent adverse events (AE)s at each visit and underwent visual function and retinal imaging assessments and biological sampling as per the schedule of assessments. This study was conducted in compliance with Independent ethics committees (IECs) / Institutional review boards (IRBs), informed consent regulations, the Declaration of Helsinki, nternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and the Food and Drug Administration (FDA) guidance.
Interventions
BIOLOGICALGT005
GT005 is a recombinant, non-replicating AAV2 expressing human complement factor I (CFI). GT005 was administered as a single time subretinal injection into the study eye of subjects allocated to one of the two GT005 doses.
DEVICEGT005 / Device: Orbit™ Subretinal Delivery System
GT005 is a recombinant, non-replicating AAV2 expressing human complement factor I (CFI). A single dose of GT005 was administered with subretinal injection via suprachoroidal cannulation approach. Device: Orbit™ Subretinal Delivery System
Sponsors
Gyroscope Therapeutics Limited
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A dose escalation study of the safety and efficacy of a single subretinal injection of GT005 in subjects with Macular Atrophy due to AMD
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to give consent to study participation 2. Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, and a diagnosis of AMD in the contralateral eye (except if the subject is monocular) 3. Cohorts 1 to 6: GA lesion(s) total size in the study eye must be ≥1.25mm2 and ≤17.5mm2. Cohort 7: GA lesion(s) total size in the study eye must be ≥1.25mm2 4. GA lesion(s) in the study eye must reside completely within the FAF fundus image 5. Cohorts 1 to 3: BCVA of ≤50 letters (6/36 Snellen acuity equivalent or worse) using ETDRS charts in the study eye Cohorts 4 to 7: BCVA of ≥24 letters (6/95 and 20/320 Snellen acuity equivalent or better) using ETDRS charts in the study eye 6. Aged ≥55 years 7. Able to attend all study visits and complete the study procedures 8. Women of child-bearing potential need to have a negative urine pregnancy test within two weeks prior to receiving the drug. A pregnancy test is not required for postmenopausal women (defined as being at least 12 consecutive months without menses) or those surgically sterilised (those having a bilateral tubal ligation/bilateral salpingectomy, bilateral tubal occlusive procedure, hysterectomy, or bilateral oophorectomy)
Exclusion criteria
1. Have evidence or history of Choroidal Neovascularisation (CNV) in the study eye. Subjects are permitted to have CNV in the fellow eye defined as either: 1. Non-exudative/sub-clinical fellow eye CNV identified at screening, or 2. Known history of fellow eye CNV with either ≥2 years since diagnosis or with no active treatment required in 6 months prior to screening 2. Presence of moderate/severe non-proliferative diabetic retinopathy or worse in the study eye 3. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye 4. History of intraocular surgery in the study eye within 12 weeks prior to Screening (Visit 1). Yttrium aluminum garnet capsulotomy is permitted if performed \>10 weeks prior to Visit 1 5. Have clinically significant cataract that may require surgery during the study period in the study eye 6. Presence of moderate to severe glaucomatous optic neuropathy in the study eye; uncontrolled IOP despite the use of more than two topical agents; a history of glaucoma-filtering or valve surgery is also excluded 7. Axial myopia of greater than -8 diopters in the study eye 8. Have received any investigational product for the treatment of GA within the past 6 months or 5 half-lives (whichever is longer), other than nutritional supplements such as the Age-Related Eye Disease Study (AREDS) formula 9. Have received a gene or cell therapy at any time 10. Have a contraindication to the specified protocol corticosteroid regimen 11. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant 12. Active malignancy within the past 12 months, except for: Appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with a stable prostate-specific antigen (PSA) ≥12 months 13. Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study 14. Cohorts 5 to 7 only: presence of metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, and other implanted electrodes or stimulators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks. | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class. |
| Summary of Non-Ocular Treatment Emergent Adverse Events | Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks. | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. |
| Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred | Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks. | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Up to Week 240 | Best corrected visual acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. |
| Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Up to Week 240 | Low-Luminance Deficit best corrected visual acuity (BCVA-LLVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. |
| Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Up to Week 240 | Macular sensitivity as assessed by mesopic Microperimetry. Mesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 63 Area. |
| Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Up to Week 240 | Macular sensitivity as assessed by mesopic Microperimetry. Mesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 95 Area. |
| Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Up to Week 240 | Macular sensitivity as assessed by mesopic Microperimetry |
| Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Up to Week 240 | Macular sensitivity as assessed by mesopic Microperimetry |
| Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Up to Week 240 | Macular sensitivity as assessed by mesopic Microperimetry |
| Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Up to Week 240 | Change from baseline in GA size as assessed by fundus autofluorescence |
| Delivery of GT005 to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device | Day 1 | The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US. The rate of successful delivery of GT005 is the number of full doses delivered divided by number of Orbit devices used. This endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of GT005 administered was consistent across all arms and cohorts. The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms. |
| Delivery of Balanced Salt Solution (BSS) or BSS PLUS (BSS+) to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device | Day 1 | The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US. The rate of successful delivery of BSS was the number of full doses delivered divided by number of Orbit devices used. This endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of BSS administered was consistent across all arms and cohorts. The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms. |
| Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Day 1 | Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class. |
| Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure | Day 1 | Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class. |
| Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Day 1 | Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class. |
| Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure | Day 1 | Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class. |
Countries
United Kingdom, United States
Contacts
STUDY_DIRECTORChief Medical Officer
Novartis Pharmaceuticals
Participant flow
Pre-assignment details
The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.)
Participants by arm
| Arm | Count |
|---|---|
| GT005 2E10 vg Via Transvitreal Procedure GT005 2E10 vg via Transvitreal Procedure | 6 |
| GT005 5E10 vg Via Transvitreal Procedure GT005 5E10 vg via Transvitreal Procedure | 10 |
| GT005 2E11 vg Via Transvitreal Procedure GT005 2E11 vg via Transvitreal Procedure | 15 |
| GT005 5E10 vg With Orbit Subretinal Delivery System GT005 5E10 vg with Orbit Subretinal Delivery System | 3 |
| GT005 2E11 vg With Orbit Subretinal Delivery System GT005 2E11 vg with Orbit Subretinal Delivery System | 22 |
| Total | 56 |
Baseline characteristics
| Characteristic | Total | GT005 2E11 vg With Orbit Subretinal Delivery System | GT005 5E10 vg With Orbit Subretinal Delivery System | GT005 2E11 vg Via Transvitreal Procedure | GT005 5E10 vg Via Transvitreal Procedure | GT005 2E10 vg Via Transvitreal Procedure |
|---|---|---|---|---|---|---|
| Age, Continuous | 78.9 Years STANDARD_DEVIATION 5.93 | 77.3 Years STANDARD_DEVIATION 6.6 | 75.7 Years STANDARD_DEVIATION 4.73 | 80.5 Years STANDARD_DEVIATION 4.02 | 79.0 Years STANDARD_DEVIATION 5.12 | 81.7 Years STANDARD_DEVIATION 8.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 55 Participants | 22 Participants | 3 Participants | 14 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Female | 39 Participants | 14 Participants | 3 Participants | 11 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 17 Participants | 8 Participants | 0 Participants | 4 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 6 | 3 / 10 | 0 / 15 | 0 / 3 | 0 / 22 | 4 / 56 |
| other Total, other adverse events | 4 / 6 | 10 / 10 | 15 / 15 | 3 / 3 | 22 / 22 | 54 / 56 |
| serious Total, serious adverse events | 2 / 6 | 6 / 10 | 4 / 15 | 0 / 3 | 5 / 22 | 17 / 56 |
Outcome results
Primary
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.
Time frame: Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Population: Safety Analysis Set - All treated patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal dystrophy | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Optic disc haemorrhage | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eyelid irritation | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal abrasion | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Procedural pain | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Blepharitis | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Periorbital oedema | 1 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival deposit | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Injury, poisoning and procedural complications | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Dry eye | 1 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis bacterial | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Posterior capsule opacification | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ophthalmic migraine | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Vitreous floaters | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual field defect | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Neovascular age-related macular degeneration | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal depigmentation | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Nervous system disorders | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis viral | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual acuity reduced | 1 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal tear | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Vision blurred | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Foreign body sensation in eyes | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Choroidal neovascularisation | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Anterior chamber cell | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual impairment | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye pain | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Charles Bonnet syndrome | 1 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Infections and infestations | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal pigmentation | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal oedema | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Glaucoma | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye discharge | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Intraocular pressure increased | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Dacryostenosis acquired | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Congenital, familial and genetic disorders | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Iridocyclitis | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival haemorrhage | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Cataract | 1 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Subjects with at least one TEAE | 3 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Keratitis | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Investigations | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Macular hole | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Choroidal haemorrhage | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Suture related complication | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye pruritus | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival hyperaemia | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ocular discomfort | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Eye disorders | 3 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Central vision loss | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eyelid ptosis | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Post procedural discomfort | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ocular hypertension | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Chalazion | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal haemorrhage | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Diplopia | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Choroidal neovascularisation | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Eye disorders | 6 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival deposit | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Diplopia | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye discharge | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal dystrophy | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye pruritus | 1 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Keratitis | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eyelid irritation | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Foreign body sensation in eyes | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Charles Bonnet syndrome | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Congenital, familial and genetic disorders | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Glaucoma | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival hyperaemia | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Iridocyclitis | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Subjects with at least one TEAE | 7 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Macular hole | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual field defect | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ocular discomfort | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ocular hypertension | 1 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eyelid ptosis | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Blepharitis | 3 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Optic disc haemorrhage | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Periorbital oedema | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Posterior capsule opacification | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal tear | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal depigmentation | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Vision blurred | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual acuity reduced | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual impairment | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Anterior chamber cell | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Infections and infestations | 3 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis viral | 2 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Dry eye | 2 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis bacterial | 1 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Vitreous floaters | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Injury, poisoning and procedural complications | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Procedural pain | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal haemorrhage | 2 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal abrasion | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Neovascular age-related macular degeneration | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Post procedural discomfort | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Suture related complication | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Central vision loss | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Cataract | 3 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Investigations | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Intraocular pressure increased | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Nervous system disorders | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival haemorrhage | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ophthalmic migraine | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Chalazion | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal pigmentation | 4 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal oedema | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Choroidal haemorrhage | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye pain | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Dacryostenosis acquired | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye discharge | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Procedural pain | 3 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual field defect | 3 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal pigmentation | 10 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Optic disc haemorrhage | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival deposit | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal abrasion | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Eye disorders | 13 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ocular hypertension | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Blepharitis | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Diplopia | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Post procedural discomfort | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ocular discomfort | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Cataract | 7 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Macular hole | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal dystrophy | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Suture related complication | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye pain | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal oedema | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Subjects with at least one TEAE | 14 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Chalazion | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Investigations | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Central vision loss | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Iridocyclitis | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Glaucoma | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival hyperaemia | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Intraocular pressure increased | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Foreign body sensation in eyes | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival haemorrhage | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Congenital, familial and genetic disorders | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Choroidal neovascularisation | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual acuity reduced | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Nervous system disorders | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Infections and infestations | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual impairment | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Anterior chamber cell | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Vision blurred | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Keratitis | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Neovascular age-related macular degeneration | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Dry eye | 2 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal depigmentation | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Choroidal haemorrhage | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis viral | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Posterior capsule opacification | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eyelid irritation | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal tear | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Dacryostenosis acquired | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis bacterial | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ophthalmic migraine | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Charles Bonnet syndrome | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Periorbital oedema | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye pruritus | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Injury, poisoning and procedural complications | 4 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Vitreous floaters | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal haemorrhage | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eyelid ptosis | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual field defect | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Charles Bonnet syndrome | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye pain | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eyelid ptosis | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual acuity reduced | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Vitreous floaters | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Central vision loss | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Chalazion | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Iridocyclitis | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Keratitis | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Macular hole | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ocular discomfort | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ocular hypertension | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Optic disc haemorrhage | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Periorbital oedema | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Posterior capsule opacification | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal depigmentation | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Vision blurred | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual impairment | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Infections and infestations | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis viral | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis bacterial | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Injury, poisoning and procedural complications | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Procedural pain | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal abrasion | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Post procedural discomfort | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Suture related complication | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Investigations | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Intraocular pressure increased | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Nervous system disorders | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ophthalmic migraine | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival deposit | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal oedema | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Choroidal haemorrhage | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Choroidal neovascularisation | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Dacryostenosis acquired | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Diplopia | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye discharge | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye pruritus | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eyelid irritation | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Foreign body sensation in eyes | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Glaucoma | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Subjects with at least one TEAE | 3 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Congenital, familial and genetic disorders | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal dystrophy | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Eye disorders | 3 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal pigmentation | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival haemorrhage | 3 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Cataract | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal haemorrhage | 3 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Dry eye | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Anterior chamber cell | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal tear | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Blepharitis | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival hyperaemia | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Neovascular age-related macular degeneration | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Choroidal haemorrhage | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Charles Bonnet syndrome | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Eye disorders | 21 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal oedema | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival deposit | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Chalazion | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival hyperaemia | 2 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal pigmentation | 8 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ophthalmic migraine | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Nervous system disorders | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Intraocular pressure increased | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Central vision loss | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctival haemorrhage | 15 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Investigations | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Suture related complication | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Post procedural discomfort | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Vitreous floaters | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Cataract | 2 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal abrasion | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Procedural pain | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Injury, poisoning and procedural complications | 3 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual acuity reduced | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal haemorrhage | 5 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis bacterial | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis viral | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Conjunctivitis | 2 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual field defect | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Dry eye | 2 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Infections and infestations | 2 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Visual impairment | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Vision blurred | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Neovascular age-related macular degeneration | 2 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Anterior chamber cell | 3 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal depigmentation | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Posterior capsule opacification | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Periorbital oedema | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eyelid ptosis | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Retinal tear | 4 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Optic disc haemorrhage | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ocular hypertension | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Ocular discomfort | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye pain | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Blepharitis | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Macular hole | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Subjects with at least one TEAE | 21 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Glaucoma | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Foreign body sensation in eyes | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eyelid irritation | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Keratitis | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | Congenital, familial and genetic disorders | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye pruritus | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Eye discharge | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Diplopia | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Iridocyclitis | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Corneal dystrophy | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Dacryostenosis acquired | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye | -Choroidal neovascularisation | 0 Participants |
Primary
Summary of Non-Ocular Treatment Emergent Adverse Events
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.
Time frame: Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Population: Safety Analysis Set - All treated patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Non-Ocular Treatment Emergent Adverse Events | 4 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Non-Ocular Treatment Emergent Adverse Events | 10 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Non-Ocular Treatment Emergent Adverse Events | 14 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Non-Ocular Treatment Emergent Adverse Events | 3 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Non-Ocular Treatment Emergent Adverse Events | 16 Participants |
Primary
Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.
Time frame: Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Population: Safety Analysis Set - All treated patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred | 0 Participants |
Secondary
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Best corrected visual acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Time frame: Up to Week 240
Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 96 (n=4,8,14,3,18) | 31.00 ETDRS letters read | Standard Deviation 21.494 |
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 36 (n=6,6,15,3,21) | 39.00 ETDRS letters read | Standard Deviation 21.79 |
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 72 (n=3,8,14,3,18) | 32.67 ETDRS letters read | Standard Deviation 20.744 |
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 48 (n=5,9,14,3,21) | 40.60 ETDRS letters read | Standard Deviation 19.204 |
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 240 (n=2,1,2,0,0) | 25.50 ETDRS letters read | Standard Deviation 16.263 |
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 8 (n=3,4,6,3,21) | 60.33 ETDRS letters read | Standard Deviation 9.074 |
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 1 | 39.33 ETDRS letters read | Standard Deviation 16.145 |
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 192 (n=2,3,7,0,0) | 26.50 ETDRS letters read | Standard Deviation 19.092 |
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 12 (n=6,10,11,3,22) | 44.33 ETDRS letters read | Standard Deviation 21.153 |
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 144 (n=2,6,10,3,2) | 26.50 ETDRS letters read | Standard Deviation 28.991 |
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 24 (n=6,10,13,3,21) | 42.67 ETDRS letters read | Standard Deviation 24.262 |
| GT005 2E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 5 (n=6,10,14,3,22) | 42.00 ETDRS letters read | Standard Deviation 20.258 |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 24 (n=6,10,13,3,21) | 44.60 ETDRS letters read | Standard Deviation 13.81 |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 96 (n=4,8,14,3,18) | 44.13 ETDRS letters read | Standard Deviation 12.484 |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 36 (n=6,6,15,3,21) | 53.17 ETDRS letters read | Standard Deviation 12.983 |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 5 (n=6,10,14,3,22) | 46.90 ETDRS letters read | Standard Deviation 13.916 |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 144 (n=2,6,10,3,2) | 42.50 ETDRS letters read | Standard Deviation 9.628 |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 48 (n=5,9,14,3,21) | 47.22 ETDRS letters read | Standard Deviation 13.953 |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 72 (n=3,8,14,3,18) | 46.63 ETDRS letters read | Standard Deviation 15.408 |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 1 | 47.20 ETDRS letters read | Standard Deviation 16.151 |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 12 (n=6,10,11,3,22) | 46.00 ETDRS letters read | Standard Deviation 15.563 |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 192 (n=2,3,7,0,0) | 35.33 ETDRS letters read | Standard Deviation 8.505 |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 240 (n=2,1,2,0,0) | 28.00 ETDRS letters read | — |
| GT005 5E10 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 8 (n=3,4,6,3,21) | 55.25 ETDRS letters read | Standard Deviation 9.674 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 240 (n=2,1,2,0,0) | 25.50 ETDRS letters read | Standard Deviation 7.778 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 1 | 47.20 ETDRS letters read | Standard Deviation 17.449 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 5 (n=6,10,14,3,22) | 45.57 ETDRS letters read | Standard Deviation 19.747 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 8 (n=3,4,6,3,21) | 55.67 ETDRS letters read | Standard Deviation 12.675 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 12 (n=6,10,11,3,22) | 54.73 ETDRS letters read | Standard Deviation 16.032 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 24 (n=6,10,13,3,21) | 48.92 ETDRS letters read | Standard Deviation 20.056 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 36 (n=6,6,15,3,21) | 43.80 ETDRS letters read | Standard Deviation 20.64 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 48 (n=5,9,14,3,21) | 47.86 ETDRS letters read | Standard Deviation 16.176 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 72 (n=3,8,14,3,18) | 46.93 ETDRS letters read | Standard Deviation 13.658 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 96 (n=4,8,14,3,18) | 43.57 ETDRS letters read | Standard Deviation 18.11 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 144 (n=2,6,10,3,2) | 43.90 ETDRS letters read | Standard Deviation 17.515 |
| GT005 2E11 vg Via Transvitreal Procedure | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 192 (n=2,3,7,0,0) | 36.43 ETDRS letters read | Standard Deviation 15.404 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 24 (n=6,10,13,3,21) | 66.67 ETDRS letters read | Standard Deviation 19.218 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 72 (n=3,8,14,3,18) | 57.33 ETDRS letters read | Standard Deviation 16.258 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 144 (n=2,6,10,3,2) | 64.00 ETDRS letters read | Standard Deviation 18.52 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 5 (n=6,10,14,3,22) | 62.67 ETDRS letters read | Standard Deviation 19.425 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 8 (n=3,4,6,3,21) | 65.33 ETDRS letters read | Standard Deviation 16.442 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 96 (n=4,8,14,3,18) | 64.67 ETDRS letters read | Standard Deviation 24.583 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 1 | 62.00 ETDRS letters read | Standard Deviation 17.436 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 48 (n=5,9,14,3,21) | 64.00 ETDRS letters read | Standard Deviation 20.518 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 12 (n=6,10,11,3,22) | 66.67 ETDRS letters read | Standard Deviation 16.166 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 36 (n=6,6,15,3,21) | 65.00 ETDRS letters read | Standard Deviation 21.932 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 8 (n=3,4,6,3,21) | 52.52 ETDRS letters read | Standard Deviation 18.101 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 72 (n=3,8,14,3,18) | 51.72 ETDRS letters read | Standard Deviation 18.162 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 12 (n=6,10,11,3,22) | 54.68 ETDRS letters read | Standard Deviation 17.705 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 96 (n=4,8,14,3,18) | 51.72 ETDRS letters read | Standard Deviation 19.393 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 24 (n=6,10,13,3,21) | 52.76 ETDRS letters read | Standard Deviation 18.144 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 1 | 52.59 ETDRS letters read | Standard Deviation 15.822 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 144 (n=2,6,10,3,2) | 56.00 ETDRS letters read | Standard Deviation 2.828 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 36 (n=6,6,15,3,21) | 52.29 ETDRS letters read | Standard Deviation 18.078 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 5 (n=6,10,14,3,22) | 52.14 ETDRS letters read | Standard Deviation 18.838 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 48 (n=5,9,14,3,21) | 51.19 ETDRS letters read | Standard Deviation 19.577 |
Secondary
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Change from baseline in GA size as assessed by fundus autofluorescence
Time frame: Up to Week 240
Population: Full Analysis Set - for patients with a valid measurement without a protocol deviation with impact
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 144 (n=2,6,8,3,2) | 0.62 mm | Standard Deviation 0.137 |
| GT005 2E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 72 (n=3,8,14,3,17) | 0.57 mm | Standard Deviation 0.374 |
| GT005 2E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 48 (n=5,9,13,3,21) | 0.57 mm | Standard Deviation 0.259 |
| GT005 2E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 240 (n=2,0,2,0,0) | 1.07 mm | Standard Deviation 0.216 |
| GT005 2E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 12 (n=6,10,10,3,21) | 0.13 mm | Standard Deviation 0.105 |
| GT005 2E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 5 (n=6,10,13,3,20) | 0.06 mm | Standard Deviation 0.081 |
| GT005 2E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 192 (n=2,2,5,0,0) | 0.89 mm | Standard Deviation 0.112 |
| GT005 2E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 24 (n=6,10,13,3,19) | 0.20 mm | Standard Deviation 0.161 |
| GT005 2E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 96 (n=4,8,13,2,18) | 0.59 mm | Standard Deviation 0.424 |
| GT005 2E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 36 (n=5,5,15,3,19) | 0.38 mm | Standard Deviation 0.232 |
| GT005 5E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 72 (n=3,8,14,3,17) | 0.27 mm | Standard Deviation 0.09 |
| GT005 5E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 96 (n=4,8,13,2,18) | 0.33 mm | Standard Deviation 0.113 |
| GT005 5E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 144 (n=2,6,8,3,2) | 0.42 mm | Standard Deviation 0.081 |
| GT005 5E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 48 (n=5,9,13,3,21) | 0.23 mm | Standard Deviation 0.105 |
| GT005 5E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 36 (n=5,5,15,3,19) | 0.18 mm | Standard Deviation 0.098 |
| GT005 5E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 192 (n=2,2,5,0,0) | 0.46 mm | Standard Deviation 0.042 |
| GT005 5E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 24 (n=6,10,13,3,19) | 0.13 mm | Standard Deviation 0.053 |
| GT005 5E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 12 (n=6,10,10,3,21) | 0.09 mm | Standard Deviation 0.037 |
| GT005 5E10 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 5 (n=6,10,13,3,20) | 0.06 mm | Standard Deviation 0.028 |
| GT005 2E11 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 96 (n=4,8,13,2,18) | 0.54 mm | Standard Deviation 0.246 |
| GT005 2E11 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 5 (n=6,10,13,3,20) | 0.06 mm | Standard Deviation 0.045 |
| GT005 2E11 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 12 (n=6,10,10,3,21) | 0.12 mm | Standard Deviation 0.061 |
| GT005 2E11 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 24 (n=6,10,13,3,19) | 0.22 mm | Standard Deviation 0.109 |
| GT005 2E11 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 36 (n=5,5,15,3,19) | 0.25 mm | Standard Deviation 0.101 |
| GT005 2E11 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 48 (n=5,9,13,3,21) | 0.30 mm | Standard Deviation 0.118 |
| GT005 2E11 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 72 (n=3,8,14,3,17) | 0.43 mm | Standard Deviation 0.214 |
| GT005 2E11 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 144 (n=2,6,8,3,2) | 0.77 mm | Standard Deviation 0.329 |
| GT005 2E11 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 192 (n=2,2,5,0,0) | 0.89 mm | Standard Deviation 0.346 |
| GT005 2E11 vg Via Transvitreal Procedure | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 240 (n=2,0,2,0,0) | 1.07 mm | Standard Deviation 0.007 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 36 (n=5,5,15,3,19) | 0.40 mm | Standard Deviation 0.31 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 72 (n=3,8,14,3,17) | 0.57 mm | Standard Deviation 0.425 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 24 (n=6,10,13,3,19) | 0.37 mm | Standard Deviation 0.296 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 96 (n=4,8,13,2,18) | 0.70 mm | Standard Deviation 0.822 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 5 (n=6,10,13,3,20) | 0.17 mm | Standard Deviation 0.147 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 144 (n=2,6,8,3,2) | 0.99 mm | Standard Deviation 0.79 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 12 (n=6,10,10,3,21) | 0.26 mm | Standard Deviation 0.223 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 48 (n=5,9,13,3,21) | 0.48 mm | Standard Deviation 0.384 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 5 (n=6,10,13,3,20) | 0.08 mm | Standard Deviation 0.064 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 48 (n=5,9,13,3,21) | 0.35 mm | Standard Deviation 0.155 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 72 (n=3,8,14,3,17) | 0.50 mm | Standard Deviation 0.247 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 24 (n=6,10,13,3,19) | 0.22 mm | Standard Deviation 0.111 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 144 (n=2,6,8,3,2) | 0.98 mm | Standard Deviation 0.144 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 96 (n=4,8,13,2,18) | 0.60 mm | Standard Deviation 0.282 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 36 (n=5,5,15,3,19) | 0.29 mm | Standard Deviation 0.13 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye | Week 12 (n=6,10,10,3,21) | 0.15 mm | Standard Deviation 0.096 |
Secondary
Delivery of Balanced Salt Solution (BSS) or BSS PLUS (BSS+) to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device
The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US. The rate of successful delivery of BSS was the number of full doses delivered divided by number of Orbit devices used. This endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of BSS administered was consistent across all arms and cohorts. The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.
Time frame: Day 1
Population: All Enrolled Set - For the 28 participants in the US where the Orbit Subretinal Delivery System was attempted.~34 devices were used for 28 total pts - some deliveries took more than 1 attempt before the delivery was successful. If a delivery failed, a new attempt with a new device was conducted.~The arms for this endpoint are combined per the SAP, because the endpoint is independent of the dose; only the attempted and successful delivery via the Orbit SDS device is of relevance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Delivery of Balanced Salt Solution (BSS) or BSS PLUS (BSS+) to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device | 76.5 percent of devices |
Secondary
Delivery of GT005 to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device
The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US. The rate of successful delivery of GT005 is the number of full doses delivered divided by number of Orbit devices used. This endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of GT005 administered was consistent across all arms and cohorts. The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.
Time frame: Day 1
Population: All Enrolled Set - For the 28 participants in the US where the Orbit Subretinal Delivery System was attempted.~34 devices were used for 28 total pts - some deliveries took more than 1 attempt before the delivery was successful. If a delivery failed, a new attempt with a new device was conducted.~The arms for this endpoint are combined per the SAP, because the endpoint is independent of the dose; only the attempted and successful delivery via the Orbit SDS device is of relevance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Delivery of GT005 to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device | 70.6 percent of devices |
Secondary
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Low-Luminance Deficit best corrected visual acuity (BCVA-LLVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Time frame: Up to Week 240
Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 144 (n=2,6,10,3,2) | 5.50 ETDRS letters read | Standard Deviation 6.364 |
| GT005 2E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 24 (n=6,10,13,3,21) | 32.25 ETDRS letters read | Standard Deviation 29.205 |
| GT005 2E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 36 (n=4,6,15,3,20) | 26.75 ETDRS letters read | Standard Deviation 24.865 |
| GT005 2E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 48 (n=5,9,14,3,21) | 19.60 ETDRS letters read | Standard Deviation 14.415 |
| GT005 2E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 72 (n=3,8,14,3,18) | 20.33 ETDRS letters read | Standard Deviation 14.154 |
| GT005 2E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 96 (n=4,8,14,3,18) | 16.25 ETDRS letters read | Standard Deviation 9.215 |
| GT005 2E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 12 (n=3,9,11,3,22) | 40.00 ETDRS letters read | Standard Deviation 21.517 |
| GT005 2E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 192 (n=2,3,7,0,0) | 2.00 ETDRS letters read | Standard Deviation 1.414 |
| GT005 2E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 240 (n=2,1,2,0,0) | 7.50 ETDRS letters read | Standard Deviation 2.121 |
| GT005 5E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 96 (n=4,8,14,3,18) | 8.88 ETDRS letters read | Standard Deviation 4.643 |
| GT005 5E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 144 (n=2,6,10,3,2) | 6.50 ETDRS letters read | Standard Deviation 4.55 |
| GT005 5E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 24 (n=6,10,13,3,21) | 15.80 ETDRS letters read | Standard Deviation 15.061 |
| GT005 5E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 240 (n=2,1,2,0,0) | 9.00 ETDRS letters read | — |
| GT005 5E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 48 (n=5,9,14,3,21) | 15.11 ETDRS letters read | Standard Deviation 13.968 |
| GT005 5E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 36 (n=4,6,15,3,20) | 21.00 ETDRS letters read | Standard Deviation 14.656 |
| GT005 5E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 192 (n=2,3,7,0,0) | 5.00 ETDRS letters read | Standard Deviation 1.414 |
| GT005 5E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 72 (n=3,8,14,3,18) | 13.13 ETDRS letters read | Standard Deviation 9.538 |
| GT005 5E10 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 12 (n=3,9,11,3,22) | 14.67 ETDRS letters read | Standard Deviation 17.951 |
| GT005 2E11 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 36 (n=4,6,15,3,20) | 15.07 ETDRS letters read | Standard Deviation 15.144 |
| GT005 2E11 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 24 (n=6,10,13,3,21) | 17.23 ETDRS letters read | Standard Deviation 13.893 |
| GT005 2E11 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 144 (n=2,6,10,3,2) | 18.80 ETDRS letters read | Standard Deviation 18.76 |
| GT005 2E11 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 240 (n=2,1,2,0,0) | 5.50 ETDRS letters read | Standard Deviation 3.536 |
| GT005 2E11 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 12 (n=3,9,11,3,22) | 18.91 ETDRS letters read | Standard Deviation 14.321 |
| GT005 2E11 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 96 (n=4,8,14,3,18) | 13.07 ETDRS letters read | Standard Deviation 15.711 |
| GT005 2E11 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 192 (n=2,3,7,0,0) | 13.00 ETDRS letters read | Standard Deviation 9.22 |
| GT005 2E11 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 72 (n=3,8,14,3,18) | 15.36 ETDRS letters read | Standard Deviation 17.095 |
| GT005 2E11 vg Via Transvitreal Procedure | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 48 (n=5,9,14,3,21) | 17.36 ETDRS letters read | Standard Deviation 15.736 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 24 (n=6,10,13,3,21) | 27.00 ETDRS letters read | Standard Deviation 20.952 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 36 (n=4,6,15,3,20) | 30.00 ETDRS letters read | Standard Deviation 30.806 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 48 (n=5,9,14,3,21) | 31.67 ETDRS letters read | Standard Deviation 24.194 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 72 (n=3,8,14,3,18) | 33.67 ETDRS letters read | Standard Deviation 25.007 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 96 (n=4,8,14,3,18) | 36.00 ETDRS letters read | Standard Deviation 23.065 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 12 (n=3,9,11,3,22) | 28.67 ETDRS letters read | Standard Deviation 17.214 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 144 (n=2,6,10,3,2) | 39.67 ETDRS letters read | Standard Deviation 22.679 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 48 (n=5,9,14,3,21) | 18.48 ETDRS letters read | Standard Deviation 13.938 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 144 (n=2,6,10,3,2) | 26.00 ETDRS letters read | Standard Deviation 26.87 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 12 (n=3,9,11,3,22) | 24.82 ETDRS letters read | Standard Deviation 16.229 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 24 (n=6,10,13,3,21) | 22.52 ETDRS letters read | Standard Deviation 14.473 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 36 (n=4,6,15,3,20) | 20.10 ETDRS letters read | Standard Deviation 14.242 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 96 (n=4,8,14,3,18) | 21.56 ETDRS letters read | Standard Deviation 13.984 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye | Week 72 (n=3,8,14,3,18) | 21.22 ETDRS letters read | Standard Deviation 12.735 |
Secondary
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)
Macular sensitivity as assessed by mesopic Microperimetry. Mesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 63 Area.
Time frame: Up to Week 240
Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 72 (n=1,8,13,2,10) | 17.80 degrees squared (deg2) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 144 (n=1,5,8,2,0) | 12.20 degrees squared (deg2) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 96 (n=2,8,13,1,7) | 10.90 degrees squared (deg2) | Standard Deviation 2.546 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 24 (n=3,9,10,3,11) | 16.17 degrees squared (deg2) | Standard Deviation 15.97 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 240 (1,1,2,0,0) | 40.20 degrees squared (deg2) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 48 (n=2,9,14,2,10) | 8.50 degrees squared (deg2) | Standard Deviation 3.677 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 12 (n=2,9,11,1,10) | 16.80 degrees squared (deg2) | Standard Deviation 5.94 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 192 (1,2,7,0,0) | 38.90 degrees squared (deg2) | — |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 144 (n=1,5,8,2,0) | 18.80 degrees squared (deg2) | Standard Deviation 18.404 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 240 (1,1,2,0,0) | 11.10 degrees squared (deg2) | — |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 192 (1,2,7,0,0) | 7.70 degrees squared (deg2) | Standard Deviation 0.283 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 96 (n=2,8,13,1,7) | 14.65 degrees squared (deg2) | Standard Deviation 10.059 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 72 (n=1,8,13,2,10) | 13.33 degrees squared (deg2) | Standard Deviation 6.887 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 48 (n=2,9,14,2,10) | 19.41 degrees squared (deg2) | Standard Deviation 19.557 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 24 (n=3,9,10,3,11) | 17.10 degrees squared (deg2) | Standard Deviation 17.891 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 12 (n=2,9,11,1,10) | 15.64 degrees squared (deg2) | Standard Deviation 13.013 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 240 (1,1,2,0,0) | 18.85 degrees squared (deg2) | Standard Deviation 24.395 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 12 (n=2,9,11,1,10) | 7.82 degrees squared (deg2) | Standard Deviation 8.232 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 24 (n=3,9,10,3,11) | 12.13 degrees squared (deg2) | Standard Deviation 11.483 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 48 (n=2,9,14,2,10) | 11.96 degrees squared (deg2) | Standard Deviation 7.939 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 72 (n=1,8,13,2,10) | 12.10 degrees squared (deg2) | Standard Deviation 7.97 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 96 (n=2,8,13,1,7) | 10.40 degrees squared (deg2) | Standard Deviation 6.389 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 144 (n=1,5,8,2,0) | 13.05 degrees squared (deg2) | Standard Deviation 7.505 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 192 (1,2,7,0,0) | 13.80 degrees squared (deg2) | Standard Deviation 8.565 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 96 (n=2,8,13,1,7) | 0.30 degrees squared (deg2) | — |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 72 (n=1,8,13,2,10) | 27.65 degrees squared (deg2) | Standard Deviation 38.254 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 144 (n=1,5,8,2,0) | 4.30 degrees squared (deg2) | Standard Deviation 5.233 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 48 (n=2,9,14,2,10) | 48.55 degrees squared (deg2) | Standard Deviation 50.134 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 12 (n=2,9,11,1,10) | 36.90 degrees squared (deg2) | — |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 24 (n=3,9,10,3,11) | 14.40 degrees squared (deg2) | Standard Deviation 20.809 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 24 (n=3,9,10,3,11) | 10.38 degrees squared (deg2) | Standard Deviation 11.05 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 48 (n=2,9,14,2,10) | 11.34 degrees squared (deg2) | Standard Deviation 7.527 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 12 (n=2,9,11,1,10) | 5.97 degrees squared (deg2) | Standard Deviation 3.726 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 96 (n=2,8,13,1,7) | 6.11 degrees squared (deg2) | Standard Deviation 4.171 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2) | Week 72 (n=1,8,13,2,10) | 9.66 degrees squared (deg2) | Standard Deviation 6.935 |
Secondary
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)
Macular sensitivity as assessed by mesopic Microperimetry. Mesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 95 Area.
Time frame: Up to Week 240
Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 72 (n=1,8,13,2,10) | 53.40 degrees squared (deg2) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 144 (n=1,5,8,2,0) | 36.60 degrees squared (deg2) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 96 (n=2,8,13,1,7) | 32.70 degrees squared (deg2) | Standard Deviation 7.495 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 24 (n=3,9,10,3,11) | 48.37 degrees squared (deg2) | Standard Deviation 47.853 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 240 (1,1,2,0,0) | 120.40 degrees squared (deg2) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 48 (n=2,9,14,2,10) | 25.45 degrees squared (deg2) | Standard Deviation 10.96 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 12 (n=2,9,11,1,10) | 50.40 degrees squared (deg2) | Standard Deviation 17.819 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 192 (1,2,7,0,0) | 116.40 degrees squared (deg2) | — |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 144 (n=1,5,8,2,0) | 56.32 degrees squared (deg2) | Standard Deviation 55.119 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 240 (1,1,2,0,0) | 33.40 degrees squared (deg2) | — |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 192 (1,2,7,0,0) | 23.15 degrees squared (deg2) | Standard Deviation 0.778 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 96 (n=2,8,13,1,7) | 43.90 degrees squared (deg2) | Standard Deviation 30.123 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 72 (n=1,8,13,2,10) | 39.94 degrees squared (deg2) | Standard Deviation 20.603 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 48 (n=2,9,14,2,10) | 58.17 degrees squared (deg2) | Standard Deviation 58.589 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 24 (n=3,9,10,3,11) | 51.20 degrees squared (deg2) | Standard Deviation 53.652 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 12 (n=2,9,11,1,10) | 46.86 degrees squared (deg2) | Standard Deviation 39.037 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 240 (1,1,2,0,0) | 56.60 degrees squared (deg2) | Standard Deviation 73.115 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 12 (n=2,9,11,1,10) | 23.43 degrees squared (deg2) | Standard Deviation 24.638 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 24 (n=3,9,10,3,11) | 36.28 degrees squared (deg2) | Standard Deviation 34.454 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 48 (n=2,9,14,2,10) | 35.79 degrees squared (deg2) | Standard Deviation 23.804 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 72 (n=1,8,13,2,10) | 36.28 degrees squared (deg2) | Standard Deviation 23.848 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 96 (n=2,8,13,1,7) | 31.15 degrees squared (deg2) | Standard Deviation 19.152 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 144 (n=1,5,8,2,0) | 39.13 degrees squared (deg2) | Standard Deviation 22.511 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 192 (1,2,7,0,0) | 41.33 degrees squared (deg2) | Standard Deviation 25.644 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 96 (n=2,8,13,1,7) | 0.80 degrees squared (deg2) | — |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 72 (n=1,8,13,2,10) | 82.90 degrees squared (deg2) | Standard Deviation 114.693 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 144 (n=1,5,8,2,0) | 12.85 degrees squared (deg2) | Standard Deviation 15.768 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 48 (n=2,9,14,2,10) | 145.40 degrees squared (deg2) | Standard Deviation 150.331 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 12 (n=2,9,11,1,10) | 110.70 degrees squared (deg2) | — |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 24 (n=3,9,10,3,11) | 43.23 degrees squared (deg2) | Standard Deviation 62.405 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 24 (n=3,9,10,3,11) | 31.09 degrees squared (deg2) | Standard Deviation 33.157 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 48 (n=2,9,14,2,10) | 33.96 degrees squared (deg2) | Standard Deviation 22.632 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 12 (n=2,9,11,1,10) | 17.81 degrees squared (deg2) | Standard Deviation 11.12 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 96 (n=2,8,13,1,7) | 18.30 degrees squared (deg2) | Standard Deviation 12.563 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2) | Week 72 (n=1,8,13,2,10) | 28.90 degrees squared (deg2) | Standard Deviation 20.743 |
Secondary
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)
Macular sensitivity as assessed by mesopic Microperimetry
Time frame: Up to Week 240
Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 72 (n=1,8,13,2,10) | 13.00 Decibel (dB) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 144 (n=1,5,8,2,0) | 4.00 Decibel (dB) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 96 (n=2,8,13,1,7) | 8.70 Decibel (dB) | Standard Deviation 2.687 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 24 (n=3,9,10,3,11) | 4.20 Decibel (dB) | Standard Deviation 3.704 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 240 (1,1,2,0,0) | 1.40 Decibel (dB) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 48 (n=2,9,14,2,10) | 5.75 Decibel (dB) | Standard Deviation 0.354 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 12 (n=2,9,11,1,10) | 14.30 Decibel (dB) | Standard Deviation 2.121 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 192 (1,2,7,0,0) | 3.90 Decibel (dB) | — |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 144 (n=1,5,8,2,0) | 7.52 Decibel (dB) | Standard Deviation 6.222 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 240 (1,1,2,0,0) | 1.70 Decibel (dB) | — |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 192 (1,2,7,0,0) | 6.45 Decibel (dB) | Standard Deviation 5.728 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 96 (n=2,8,13,1,7) | 6.06 Decibel (dB) | Standard Deviation 6.283 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 72 (n=1,8,13,2,10) | 6.89 Decibel (dB) | Standard Deviation 6.163 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 48 (n=2,9,14,2,10) | 6.71 Decibel (dB) | Standard Deviation 6.065 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 24 (n=3,9,10,3,11) | 7.31 Decibel (dB) | Standard Deviation 5.736 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 12 (n=2,9,11,1,10) | 7.76 Decibel (dB) | Standard Deviation 5.536 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 240 (1,1,2,0,0) | 7.85 Decibel (dB) | Standard Deviation 6.435 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 12 (n=2,9,11,1,10) | 11.92 Decibel (dB) | Standard Deviation 5.165 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 24 (n=3,9,10,3,11) | 10.63 Decibel (dB) | Standard Deviation 5.263 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 48 (n=2,9,14,2,10) | 9.96 Decibel (dB) | Standard Deviation 4.726 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 72 (n=1,8,13,2,10) | 8.93 Decibel (dB) | Standard Deviation 5.416 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 96 (n=2,8,13,1,7) | 8.54 Decibel (dB) | Standard Deviation 4.859 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 144 (n=1,5,8,2,0) | 9.58 Decibel (dB) | Standard Deviation 6.123 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 192 (1,2,7,0,0) | 6.87 Decibel (dB) | Standard Deviation 6.145 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 96 (n=2,8,13,1,7) | 10.20 Decibel (dB) | — |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 72 (n=1,8,13,2,10) | 8.55 Decibel (dB) | Standard Deviation 3.748 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 144 (n=1,5,8,2,0) | 12.45 Decibel (dB) | Standard Deviation 4.313 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 48 (n=2,9,14,2,10) | 10.50 Decibel (dB) | Standard Deviation 4.525 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 12 (n=2,9,11,1,10) | 0.90 Decibel (dB) | — |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 24 (n=3,9,10,3,11) | 9.17 Decibel (dB) | Standard Deviation 8.259 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 24 (n=3,9,10,3,11) | 13.02 Decibel (dB) | Standard Deviation 4.125 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 48 (n=2,9,14,2,10) | 12.19 Decibel (dB) | Standard Deviation 5.096 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 12 (n=2,9,11,1,10) | 13.51 Decibel (dB) | Standard Deviation 3.35 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 96 (n=2,8,13,1,7) | 11.19 Decibel (dB) | Standard Deviation 4.245 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB) | Week 72 (n=1,8,13,2,10) | 11.80 Decibel (dB) | Standard Deviation 3.435 |
Secondary
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points
Macular sensitivity as assessed by mesopic Microperimetry
Time frame: Up to Week 240
Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 192 (1,2,7,0,0) | 40.0 MP Number of Scotomatous Points | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 72 (n=1,8,13,2,10) | 9.0 MP Number of Scotomatous Points | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 48 (n=2,9,14,2,10) | 40.0 MP Number of Scotomatous Points | Standard Deviation 1.41 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 240 (1,1,2,0,0) | 46.0 MP Number of Scotomatous Points | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 144 (n=1,5,8,2,0) | 44.0 MP Number of Scotomatous Points | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 96 (n=2,8,13,1,7) | 26.0 MP Number of Scotomatous Points | Standard Deviation 18.38 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 24 (n=3,9,10,3,11) | 44.3 MP Number of Scotomatous Points | Standard Deviation 14.01 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 12 (n=2,9,11,1,10) | 6.0 MP Number of Scotomatous Points | Standard Deviation 0 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 72 (n=1,8,13,2,10) | 35.0 MP Number of Scotomatous Points | Standard Deviation 15.07 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 12 (n=2,9,11,1,10) | 29.3 MP Number of Scotomatous Points | Standard Deviation 13.13 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 24 (n=3,9,10,3,11) | 30.8 MP Number of Scotomatous Points | Standard Deviation 13.15 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 48 (n=2,9,14,2,10) | 34.2 MP Number of Scotomatous Points | Standard Deviation 15.08 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 96 (n=2,8,13,1,7) | 36.4 MP Number of Scotomatous Points | Standard Deviation 16.09 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 144 (n=1,5,8,2,0) | 32.2 MP Number of Scotomatous Points | Standard Deviation 16.93 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 192 (1,2,7,0,0) | 37.0 MP Number of Scotomatous Points | Standard Deviation 22.63 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 240 (1,1,2,0,0) | 50.0 MP Number of Scotomatous Points | — |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 24 (n=3,9,10,3,11) | 23.6 MP Number of Scotomatous Points | Standard Deviation 12.76 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 240 (1,1,2,0,0) | 33.0 MP Number of Scotomatous Points | Standard Deviation 16.97 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 48 (n=2,9,14,2,10) | 22.0 MP Number of Scotomatous Points | Standard Deviation 11.73 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 72 (n=1,8,13,2,10) | 24.7 MP Number of Scotomatous Points | Standard Deviation 12.3 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 192 (1,2,7,0,0) | 32.4 MP Number of Scotomatous Points | Standard Deviation 18.12 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 96 (n=2,8,13,1,7) | 27.5 MP Number of Scotomatous Points | Standard Deviation 13.33 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 12 (n=2,9,11,1,10) | 20.4 MP Number of Scotomatous Points | Standard Deviation 12.78 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 144 (n=1,5,8,2,0) | 27.6 MP Number of Scotomatous Points | Standard Deviation 15.82 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 96 (n=2,8,13,1,7) | 17.0 MP Number of Scotomatous Points | — |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 48 (n=2,9,14,2,10) | 16.5 MP Number of Scotomatous Points | Standard Deviation 7.78 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 24 (n=3,9,10,3,11) | 21.0 MP Number of Scotomatous Points | Standard Deviation 22.52 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 72 (n=1,8,13,2,10) | 19.5 MP Number of Scotomatous Points | Standard Deviation 9.19 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 12 (n=2,9,11,1,10) | 44.0 MP Number of Scotomatous Points | — |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 144 (n=1,5,8,2,0) | 17.0 MP Number of Scotomatous Points | Standard Deviation 9.9 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 48 (n=2,9,14,2,10) | 15.0 MP Number of Scotomatous Points | Standard Deviation 7.77 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 72 (n=1,8,13,2,10) | 15.9 MP Number of Scotomatous Points | Standard Deviation 7.37 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 12 (n=2,9,11,1,10) | 11.9 MP Number of Scotomatous Points | Standard Deviation 4.75 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 96 (n=2,8,13,1,7) | 17.0 MP Number of Scotomatous Points | Standard Deviation 4.86 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points | Week 24 (n=3,9,10,3,11) | 12.5 MP Number of Scotomatous Points | Standard Deviation 5.87 |
Secondary
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)
Macular sensitivity as assessed by mesopic Microperimetry
Time frame: Up to Week 240
Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 72 (n=1,8,13,2,10) | 13.0 MP Percent Fixation Loss (%) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 144 (n=1,5,8,2,0) | 0.0 MP Percent Fixation Loss (%) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 96 (n=2,8,13,1,7) | 8.5 MP Percent Fixation Loss (%) | Standard Deviation 12.02 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 24 (n=3,9,10,3,11) | 0.0 MP Percent Fixation Loss (%) | Standard Deviation 0 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 240 (1,1,2,0,0) | 0.0 MP Percent Fixation Loss (%) | — |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 48 (n=2,9,14,2,10) | 0.0 MP Percent Fixation Loss (%) | Standard Deviation 0 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 12 (n=2,9,11,1,10) | 4.0 MP Percent Fixation Loss (%) | Standard Deviation 5.66 |
| GT005 2E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 192 (1,2,7,0,0) | 0.0 MP Percent Fixation Loss (%) | — |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 144 (n=1,5,8,2,0) | 0.0 MP Percent Fixation Loss (%) | Standard Deviation 0 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 240 (1,1,2,0,0) | 0.0 MP Percent Fixation Loss (%) | — |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 192 (1,2,7,0,0) | 0.0 MP Percent Fixation Loss (%) | Standard Deviation 0 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 96 (n=2,8,13,1,7) | 6.5 MP Percent Fixation Loss (%) | Standard Deviation 9.65 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 72 (n=1,8,13,2,10) | 1.8 MP Percent Fixation Loss (%) | Standard Deviation 4.95 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 48 (n=2,9,14,2,10) | 3.8 MP Percent Fixation Loss (%) | Standard Deviation 7.64 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 24 (n=3,9,10,3,11) | 9.3 MP Percent Fixation Loss (%) | Standard Deviation 17 |
| GT005 5E10 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 12 (n=2,9,11,1,10) | 9.8 MP Percent Fixation Loss (%) | Standard Deviation 13.92 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 240 (1,1,2,0,0) | 0.0 MP Percent Fixation Loss (%) | Standard Deviation 0 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 12 (n=2,9,11,1,10) | 6.9 MP Percent Fixation Loss (%) | Standard Deviation 8.69 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 24 (n=3,9,10,3,11) | 6.4 MP Percent Fixation Loss (%) | Standard Deviation 9 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 48 (n=2,9,14,2,10) | 10.5 MP Percent Fixation Loss (%) | Standard Deviation 23.45 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 72 (n=1,8,13,2,10) | 12.0 MP Percent Fixation Loss (%) | Standard Deviation 25.31 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 96 (n=2,8,13,1,7) | 10.3 MP Percent Fixation Loss (%) | Standard Deviation 9.06 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 144 (n=1,5,8,2,0) | 4.4 MP Percent Fixation Loss (%) | Standard Deviation 8.11 |
| GT005 2E11 vg Via Transvitreal Procedure | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 192 (1,2,7,0,0) | 1.7 MP Percent Fixation Loss (%) | Standard Deviation 5.38 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 96 (n=2,8,13,1,7) | 0.0 MP Percent Fixation Loss (%) | — |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 72 (n=1,8,13,2,10) | 4.0 MP Percent Fixation Loss (%) | Standard Deviation 5.66 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 144 (n=1,5,8,2,0) | 6.5 MP Percent Fixation Loss (%) | Standard Deviation 9.19 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 48 (n=2,9,14,2,10) | 0.0 MP Percent Fixation Loss (%) | Standard Deviation 0 |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 12 (n=2,9,11,1,10) | 0.0 MP Percent Fixation Loss (%) | — |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 24 (n=3,9,10,3,11) | 0.0 MP Percent Fixation Loss (%) | Standard Deviation 0 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 24 (n=3,9,10,3,11) | 11.3 MP Percent Fixation Loss (%) | Standard Deviation 8.6 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 48 (n=2,9,14,2,10) | 4.6 MP Percent Fixation Loss (%) | Standard Deviation 6.19 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 12 (n=2,9,11,1,10) | 5.5 MP Percent Fixation Loss (%) | Standard Deviation 7.11 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 96 (n=2,8,13,1,7) | 7.6 MP Percent Fixation Loss (%) | Standard Deviation 11.07 |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%) | Week 72 (n=1,8,13,2,10) | 6.2 MP Percent Fixation Loss (%) | Standard Deviation 8.52 |
Secondary
Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.
Time frame: Day 1
Population: Safety Analysis Set - All treated patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure | 0 Participants |
Secondary
Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.
Time frame: Day 1
Population: Safety Analysis Set - All treated patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure | 0 Participants |
Secondary
Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.
Time frame: Day 1
Population: Safety Analysis Set - All treated patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | 0 Participants |
Secondary
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.
Time frame: Day 1
Population: Safety Analysis Set - All treated patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Choroidal neovascularisation | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Eye disorders | 2 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Keratitis | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal haemorrhage | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal pigmentation | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Cataract | 1 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Conjunctival haemorrhage | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Iridocyclitis | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Intraocular pressure increased | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Conjunctival hyperaemia | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Periorbital oedema | 1 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Investigations | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Suture related complication | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Procedural pain | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal tear | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Anterior chamber cell | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Post procedural discomfort | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Corneal abrasion | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Foreign body sensation in eyes | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Vitreous floaters | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Injury, poisoning and procedural complications | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye pruritus | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye pain | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye discharge | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Choroidal haemorrhage | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Subjects with at least one TEAE Related to Surgical Procedure | 2 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Ocular discomfort | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Corneal oedema | 0 Participants |
| GT005 2E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Dry eye | 1 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Iridocyclitis | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Anterior chamber cell | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Conjunctival hyperaemia | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal tear | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Vitreous floaters | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Subjects with at least one TEAE Related to Surgical Procedure | 4 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Eye disorders | 4 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Conjunctival haemorrhage | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Cataract | 3 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal pigmentation | 2 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal haemorrhage | 1 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Choroidal haemorrhage | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Choroidal neovascularisation | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Corneal oedema | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Dry eye | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye discharge | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Ocular discomfort | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye pain | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye pruritus | 1 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Injury, poisoning and procedural complications | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Corneal abrasion | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Post procedural discomfort | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Procedural pain | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Suture related complication | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Investigations | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Intraocular pressure increased | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Foreign body sensation in eyes | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Keratitis | 0 Participants |
| GT005 5E10 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Periorbital oedema | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye pain | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Corneal oedema | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Dry eye | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Subjects with at least one TEAE Related to Surgical Procedure | 9 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Keratitis | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye discharge | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Vitreous floaters | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye pruritus | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Anterior chamber cell | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Injury, poisoning and procedural complications | 2 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Ocular discomfort | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Corneal abrasion | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal tear | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Post procedural discomfort | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Procedural pain | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Suture related complication | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Conjunctival hyperaemia | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Investigations | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Choroidal haemorrhage | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Periorbital oedema | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Intraocular pressure increased | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Foreign body sensation in eyes | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Conjunctival haemorrhage | 0 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Cataract | 7 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal pigmentation | 2 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Eye disorders | 8 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal haemorrhage | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Iridocyclitis | 1 Participants |
| GT005 2E11 vg Via Transvitreal Procedure | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Choroidal neovascularisation | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal tear | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal pigmentation | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Corneal oedema | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Cataract | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Subjects with at least one TEAE Related to Surgical Procedure | 3 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Choroidal neovascularisation | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Anterior chamber cell | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Procedural pain | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Dry eye | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Injury, poisoning and procedural complications | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Intraocular pressure increased | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Conjunctival hyperaemia | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Ocular discomfort | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Choroidal haemorrhage | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Suture related complication | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye discharge | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Periorbital oedema | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Post procedural discomfort | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Vitreous floaters | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Keratitis | 1 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Eye disorders | 3 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye pain | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal haemorrhage | 3 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Conjunctival haemorrhage | 3 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Investigations | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Foreign body sensation in eyes | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye pruritus | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Corneal abrasion | 0 Participants |
| GT005 5E10 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Iridocyclitis | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal tear | 3 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Injury, poisoning and procedural complications | 3 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Conjunctival haemorrhage | 14 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Eye disorders | 20 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Corneal abrasion | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Foreign body sensation in eyes | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Post procedural discomfort | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Conjunctival hyperaemia | 2 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Ocular discomfort | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Procedural pain | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal haemorrhage | 3 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Cataract | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Suture related complication | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Anterior chamber cell | 3 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Investigations | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Choroidal haemorrhage | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Corneal oedema | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Retinal pigmentation | 6 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Choroidal neovascularisation | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Dry eye | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Vitreous floaters | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Periorbital oedema | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Intraocular pressure increased | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye discharge | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Iridocyclitis | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye pain | 1 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | Subjects with at least one TEAE Related to Surgical Procedure | 20 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Keratitis | 0 Participants |
| GT005 2E11 vg With Orbit Subretinal Delivery System | Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye | -Eye pruritus | 0 Participants |