Wet Macular Degeneration
Conditions
Brief summary
This is a study in people with an eye disease called wet age-related macular degeneration (wAMD). The purpose of the study is to find out how well different doses of a medicine called BI 836880 are tolerated. People can participate if they are at least 55 years old and if they have new blood vessels in their eyes despite treatment (anti-VEGF therapies). The study has 2 parts. In the first part, people get only 1 dose of BI 836880. This part takes 6 weeks. In the second part, people get 3 times the same dose of BI 836880. This part takes 6 months. BI 836880 is injected into the eye. During the entire study doctors regularly check the health of the participants.
Interventions
DRUGBI 836880
Solution for Intravitreal (IVT) injection
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
SRD part and MRD cohort 1 (treatment-resistant patients with wAMD): * Men and women over the age of 55 with active Choroidal Neovascularisation (CNV) secondary to age-related macular degeneration (AMD) despite anti-Vascualr endothelial growth factor (VEGF) therapies (at least 3 prior injections with the last injection within 16 to 4 weeks before treatment). Active CNV secondary to AMD is to be defined either by recent fluorescein or optical coherence tomography (OCT) angiogram within 4 weeks prior to screening or fluorescein or OCT angiogram obtained prior to first anti VEGF-treatment to confirm the diagnosis and still active according to investigator judgement. * For MRD part only: Central subfield retinal thickness \>300 microns in the study eye on Heidelberg Spectralis Spectral Domain Optical Coherence Tomography (SD-OCT). * Presence of sub- and/or intraretinal fluid on SD-OCT in the study eye. * Any active CNV with subfoveal leakage in the study eye as determined by OCT * No subretinal hemorrhage involving the fovea in the study eye. * No significant subfoveal fibrosis or atrophy on SD-OCT in the study eye that, in the opinion of the investigator, is able to prevent improvement in best corrected visual acuity (BCVA) and/or central subfield thickness (CSFT). * Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 75 and 24 letters inclusive (approximately 20/32 and 20/320 or 6/9.5 and 6/95) at screening. * Best-corrected VA in the non-study eye better than best-corrected VA in the study-eye. If both eyes are eligible and have identical VA the investigator may select the study eye. * Male or female patients. Women of childbearing potential (WOCBP) cannot be included. Men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. * Signed informed consent consistent with ICH GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions. * Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order. MRD cohort 2 (treatment-naive patients with wAMD): * No subretinal hemorrhage involving the fovea in the study eye. * No significant subfoveal fibrosis or atrophy on SD-OCT in the study eye that, in the opinion of the investigator, is able to prevent improvement in BCVA and/or CSFT. * Male or female patients. Women of childbearing potential (WOCBP) cannot be included. Men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. * Signed informed consent consistent with ICH GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions. * Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order. * Men and women over the age of 55 with treatment-naïve CNV secondary to AMD. * Any CNV with subfoveal activity in the study eye defined as evidence of sub- and/or intraretinal fluid, or subretinal hyper-reflective material, or angiographic leakage. * Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 80 and 24 letters inclusive (approximately 20/25 and 20/320 or 6/7.5 and 6/95) at screening. * Best-corrected ETDRS VA in the non-study eye 50 letters inclusive (approximately 20/100 or 6/30) or better at screening. * If both eyes are eligible at screening, the study eye is the eye with the worse bestcorrected VA. MRD cohort 3 (frequently treated patients): * No subretinal hemorrhage involving the fovea in the study eye. * No significant subfoveal fibrosis or atrophy on SD-OCT in the study eye that, in the opinion of the investigator and with the endorsement of the Sponsor, is able to prevent improvement in BCVA. * Male or female patients. Women of childbearing potential (WOCBP)1 cannot be included.Men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. * Signed informed consent consistent with ICH GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions. * Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order. * Any CNV with subfoveal activity in the study eye defined as evidence of sub- and/or intraretinal fluid, or subretinal hyper-reflective material, or angiographic leakage. * Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 80 and 24 letters inclusive (approximately 20/25 and 20/320 or 6/7.5 and 6/95) at screening. * If both eyes are eligible at screening, the study eye is the eye with the worse bestcorrected VA. * Men and women over the age of 55 with diagnosed wAMD that: * require frequent wAMD SoC (28-56 days between the last 3 treatments) * have had ≥ 3 previous treatments with IVT SoC (ranibizumab, aflibercept, or bevacizumab) in the study eye * had the last SoC injection ≥ 4 weeks, but no more than 8 weeks, before the first administration of the study drug * have been on SoC treatment ≥ 6 months and are within 3 years from initial wAMD diagnosis in the study eye
Exclusion criteria
* Additional eye disease in the study eye that could compromise best corrected VA (BCVA) with visual field loss, uncontrolled glaucoma (intraocular pressure (IOP)\> 24 mmHg on more than 2 consecutive measurements prior to screening), clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinalvascular occlusion, symptomatic vitreomacular traction, or genetic disorders such as retinitis pigmentosa); history of high myopia \> 8 diopters in the study eye. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with SD-OCT. * Any prior intraocular surgery in the study eye other then uneventful lens replacement for cataract within 3 months prior to screening. * Aphakia or total absence of the posterior capsule. Yttrium aluminum garnet (YAG) laser capsulotomy permitted, more than 1 month prior to enrollment in the study eye. * Current or planned use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol). * Medical history or condition: Uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) \> 10%, myocardial infarction or stroke within 12 months of screening, active bleeding disorder, concomitant use of warfarin or anticoagulation therapy (use of antiplatelet therapy such as aspirin is allowed), major surgery within 1 month of screening or when planned within the study period, hepatic impairment, uncontrolled hypertension. * Patients with a clinically relevant abnormal screening haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs) | From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. | Single rising dose (SRD)-part: Number of participants with ocular dose limiting events (DLEs). |
| MRD-part: Number of Participants With Drug Related Adverse Events (AEs) | From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. | Multiple rising dose (MRD)-part: Number of participants with drug related adverse events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12 | At baseline and at week 12. | Multiple rising dose (MRD)-part: Central subfield thickness was measured using Spectral domain-optical coherence tomography (SD-OCT) with the assessment performed by a qualified person and only specified OCT equipment was used. Optical coherence tomography angiography (OCT-A), a non-invasive imaging technique providing high-resolution volumetric blood flow information without the use of dye was also performed by a qualified person, and only specified device(s) were used. OCT images were sent to an independent CRC for evaluation. A detailed manual for OCT image acquisition and data transmission was provided. CSFT was investigated after 3 doses of BI 836880 in the MRD part of the trial at Week 12. |
| MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12 | At baseline and at Week 12. | Multiple rising dose (MRD)-part): Visual acuity (VA) measured by 'early treatment diabetic retinopathy study' letter charts. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) VA chart starting at a test distance of 4 m. The BCVA score was the number of letters read correctly by the patient. The assessment was performed by a trained person under specified conditions regarding examination room and equipment. |
| SRD-part: Number of Participants With Drug Related Adverse Events (AEs) | From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. | Single rising dose (SRD)-part: Number of participants with drug related adverse events (AEs). |
| MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye | From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. | Multiple rising dose (MRD)-part: Number of participants with any ocular adverse events in the study eye. |
| MRD-part: Time to Recurrence in the Study Eye From Last Administration at Each Visit | From last drug administration at Week 8 until End of Trial, up to 16 weeks. | Multiple rising dose (MRD)-part: Time to recurrence was assessed in the MRD part from last trial drug administration to occurrence of any of the following in the study eye, leading to the use of wet age-related macular degeneration (wAMD) rescue medication as decided by the investigator: * Increase in Central Subfield Thickness (CFST) ≥75 μm with a decrease in Best Corrected Visual Acuity (BCVA) of ≥ 5 letters compared to Visit 5, OR * Decrease in BCVA of \>5 letters compared to baseline (Visit 2), due to worsening wAMD activity, OR * Decrease in BCVA of ≥10 letters compared to the best prior BCVA, due to worsening wAMD activity From above criteria, if Visit 5 BCVA/CSFT assessment data is missing, BCVA/CSFT values available earlier than Visit 5 will be used. The last trial drug administration is strictly referring to the third injection, if a patient doesn't complete three injections, the patient will not be evaluated for time to recurrence endpoint and will be censored. |
| SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye | From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. | Single rising dose (SRD)-part: Number of participants with any ocular adverse events in the study eye. |
Countries
Germany, United Kingdom, United States
Participant flow
Recruitment details
A non-randomised, uncontrolled, open label trial consisting of a single rising dose (SRD) part followed by a multiple rising dose (MRD) part. The SRD part and MRD cohort 1 included patients with treatment-resistant wet age-related macular degeneration (wAMD). Patients with treatment-naïve wAMD were included in MRD cohort 2 and patients within 3 years of initial wAMD were included in MRD cohort 3.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| 0.06 mg BI 836880 - SRD Part 0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 3 |
| 0.18 mg BI 836880 - SRD Part 0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 3 |
| 0.5 mg BI 836880 - SRD Part 0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 3 |
| 1 mg BI 836880 - SRD Part 1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 3 |
| 2 mg BI 836880 - SRD Part 2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 3 |
| 1 mg BI 836880 - Cohort 1 MRD Part 1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 10 |
| 2 mg BI 836680 - Cohort 2 MRD Part 2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD. | 4 |
| 2 mg BI 836680 - Cohort 3 MRD Part 2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD. | 13 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | As per sponsor decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | IMP on hold as per sponsor instructions | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Not treated | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Study medication discontinued due to safety notification | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 0.06 mg BI 836880 - SRD Part | 0.18 mg BI 836880 - SRD Part | 0.5 mg BI 836880 - SRD Part | 1 mg BI 836880 - SRD Part | 2 mg BI 836880 - SRD Part | 1 mg BI 836880 - Cohort 1 MRD Part | 2 mg BI 836680 - Cohort 2 MRD Part | 2 mg BI 836680 - Cohort 3 MRD Part | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 81.7 Years STANDARD_DEVIATION 5.7 | 76.7 Years STANDARD_DEVIATION 4.2 | 75.3 Years STANDARD_DEVIATION 1.5 | 75.7 Years STANDARD_DEVIATION 1.5 | 70.7 Years STANDARD_DEVIATION 1.2 | 77.0 Years STANDARD_DEVIATION 4.8 | 69.3 Years STANDARD_DEVIATION 13 | 77.0 Years STANDARD_DEVIATION 6.3 | 75.9 Years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 10 Participants | 4 Participants | 13 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 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 | 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 | 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 10 Participants | 4 Participants | 13 Participants | 42 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 6 Participants | 2 Participants | 7 Participants | 25 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 | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 10 | 0 / 4 | 0 / 13 |
| other Total, other adverse events | 1 / 3 | 0 / 3 | 1 / 3 | 1 / 3 | 2 / 3 | 8 / 10 | 2 / 4 | 11 / 13 |
| serious Total, serious adverse events | 1 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 2 / 10 | 0 / 4 | 4 / 13 |
Outcome results
Primary
MRD-part: Number of Participants With Drug Related Adverse Events (AEs)
Multiple rising dose (MRD)-part: Number of participants with drug related adverse events (AEs)
Time frame: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks.
Population: Treated Set: All patients who were treated with at least on dose of BI 836880. MRD-part.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.06 mg BI 836880 - SRD Part | MRD-part: Number of Participants With Drug Related Adverse Events (AEs) | 2 Participants |
| 0.18 mg BI 836880 - SRD Part | MRD-part: Number of Participants With Drug Related Adverse Events (AEs) | 1 Participants |
| 0.5 mg BI 836880 - SRD Part | MRD-part: Number of Participants With Drug Related Adverse Events (AEs) | 3 Participants |
Primary
SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs)
Single rising dose (SRD)-part: Number of participants with ocular dose limiting events (DLEs).
Time frame: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.
Population: Treated Set: All patients who were treated with at least on dose of BI 836880. SRD-part.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.06 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs) | 0 Participants |
| 0.18 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs) | 0 Participants |
| 0.5 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs) | 0 Participants |
| 1 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs) | 0 Participants |
| 2 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs) | 0 Participants |
Secondary
MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12
Multiple rising dose (MRD)-part): Visual acuity (VA) measured by 'early treatment diabetic retinopathy study' letter charts. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) VA chart starting at a test distance of 4 m. The BCVA score was the number of letters read correctly by the patient. The assessment was performed by a trained person under specified conditions regarding examination room and equipment.
Time frame: At baseline and at Week 12.
Population: Full Analysis Set (FAS): All patients who were treated with at least one dose of BI 836880 and have baseline and on-treatment CSFT measurements for the study eye in the time interval from drug administration to Week 12. MRD part.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.06 mg BI 836880 - SRD Part | MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12 | -1.2 Letters | Standard Deviation 6.4 |
| 0.18 mg BI 836880 - SRD Part | MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12 | 1.8 Letters | Standard Deviation 2.5 |
| 0.5 mg BI 836880 - SRD Part | MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12 | -4.7 Letters | Standard Deviation 22.3 |
Secondary
MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye
Multiple rising dose (MRD)-part: Number of participants with any ocular adverse events in the study eye.
Time frame: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks.
Population: Treated Set (TS): All patients who were treated with at least one dose of BI 836880. MRD-part.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.06 mg BI 836880 - SRD Part | MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye | 5 Participants |
| 0.18 mg BI 836880 - SRD Part | MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye | 1 Participants |
| 0.5 mg BI 836880 - SRD Part | MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye | 9 Participants |
Secondary
MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12
Multiple rising dose (MRD)-part: Central subfield thickness was measured using Spectral domain-optical coherence tomography (SD-OCT) with the assessment performed by a qualified person and only specified OCT equipment was used. Optical coherence tomography angiography (OCT-A), a non-invasive imaging technique providing high-resolution volumetric blood flow information without the use of dye was also performed by a qualified person, and only specified device(s) were used. OCT images were sent to an independent CRC for evaluation. A detailed manual for OCT image acquisition and data transmission was provided. CSFT was investigated after 3 doses of BI 836880 in the MRD part of the trial at Week 12.
Time frame: At baseline and at week 12.
Population: Full Analysis Set (FAS): All patients who were treated with at least one dose of BI 836880 and have baseline and on-treatment CSFT measurements for the study eye in the time interval from drug administration to Week 12. MRD part.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.06 mg BI 836880 - SRD Part | MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12 | -7.7554 Percentage change | Standard Deviation 18.9936 |
| 0.18 mg BI 836880 - SRD Part | MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12 | -26.5552 Percentage change | Standard Deviation 12.14 |
| 0.5 mg BI 836880 - SRD Part | MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12 | -0.1372 Percentage change | Standard Deviation 20.1706 |
Secondary
MRD-part: Time to Recurrence in the Study Eye From Last Administration at Each Visit
Multiple rising dose (MRD)-part: Time to recurrence was assessed in the MRD part from last trial drug administration to occurrence of any of the following in the study eye, leading to the use of wet age-related macular degeneration (wAMD) rescue medication as decided by the investigator: * Increase in Central Subfield Thickness (CFST) ≥75 μm with a decrease in Best Corrected Visual Acuity (BCVA) of ≥ 5 letters compared to Visit 5, OR * Decrease in BCVA of \>5 letters compared to baseline (Visit 2), due to worsening wAMD activity, OR * Decrease in BCVA of ≥10 letters compared to the best prior BCVA, due to worsening wAMD activity From above criteria, if Visit 5 BCVA/CSFT assessment data is missing, BCVA/CSFT values available earlier than Visit 5 will be used. The last trial drug administration is strictly referring to the third injection, if a patient doesn't complete three injections, the patient will not be evaluated for time to recurrence endpoint and will be censored.
Time frame: From last drug administration at Week 8 until End of Trial, up to 16 weeks.
Population: Treated Set (TS): All patients who were treated with at least one dose of BI 836880. MRD-part.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 0.06 mg BI 836880 - SRD Part | MRD-part: Time to Recurrence in the Study Eye From Last Administration at Each Visit | 8.0 Weeks |
| 0.18 mg BI 836880 - SRD Part | MRD-part: Time to Recurrence in the Study Eye From Last Administration at Each Visit | NA Weeks |
| 0.5 mg BI 836880 - SRD Part | MRD-part: Time to Recurrence in the Study Eye From Last Administration at Each Visit | NA Weeks |
Secondary
SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye
Single rising dose (SRD)-part: Number of participants with any ocular adverse events in the study eye.
Time frame: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.
Population: Treated Set (TS): All patients who were treated with at least one dose of BI 836880. SRD-part.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.06 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye | 1 Participants |
| 0.18 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye | 0 Participants |
| 0.5 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye | 1 Participants |
| 1 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye | 1 Participants |
| 2 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye | 2 Participants |
Secondary
SRD-part: Number of Participants With Drug Related Adverse Events (AEs)
Single rising dose (SRD)-part: Number of participants with drug related adverse events (AEs).
Time frame: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.
Population: Treated Set (TS): All patients who were treated with at least one dose of BI 836680. SRD-part.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.06 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Drug Related Adverse Events (AEs) | 0 Participants |
| 0.18 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Drug Related Adverse Events (AEs) | 0 Participants |
| 0.5 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Drug Related Adverse Events (AEs) | 0 Participants |
| 1 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Drug Related Adverse Events (AEs) | 0 Participants |
| 2 mg BI 836880 - SRD Part | SRD-part: Number of Participants With Drug Related Adverse Events (AEs) | 0 Participants |