Wet Macular Degeneration
Conditions
Brief summary
A study investigating the ability of OCTA imaging technology to identify and analyze untreated type 1, 2, and 3 neovascular membrane lesions in treatment naive patients with exudative macular degeneration, as well as investigating the ability of the OCTA imaging technology to evaluate the treatment outcomes of Intravitreal Aflibercept Injection in neovascular lesions associated with macular degeneration. This study is utilizing a new, FDA approved, non-standard of care technology (OCT-Angiography by Optovue) to image and evaluate the treatment outcomes of using standard of care Intravitreal Aflibercept Injections for their approved use in patients diagnosed with neovascular AMD who are naive to previous Anti-VEGF therapies.
Detailed description
Prospective study of neovascular AMD subjects with type 1, 2, or 3 neovascularization that have not been treated with prior anti-VEGF therapy. Subjects will be scheduled for intravitreal aflibercept injection (IAI) at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Additional injections can be administered during the remaining visits on an as needed basis per PI discretion based on the presence of any intraretinal or subretinal fluid on OCT, heme visualized on examination, reduction of BCVA by 5 or more ETDRS letters, or evidence of either increased area, density, or activity of the brush border of the neovascularization on OCT angiography. There will be a minimum of 21 days between subsequent injections. Each subject will therefore receive a minimum of 7 injections and up to a maximum of 13 injections throughout the study period. No injection will be given on the exit visit, week 52. OCT angiography and spectral domain OCT imaging will be performed at baseline and every 4 weeks thereafter The above procedures are standard of care for neovascular AMD subjects. As part of this study, these subjects will also undergo imaging of both eyes with OCTA at each visit. This is not standard of Care and is research. The only procedure that is being performed for research is the OCT-A. The injections and all other procedure are SOC based on physician discretion and clinical need. The investigators will not be modifying the dosage amounts or frequency. A subgroup of willing subjects will undergo OCT angiography every 2 weeks for the first 12 weeks. Indocyanine green angiography will be performed at baseline for all subjects to establish baseline subject population characteristics. Fluorescein angiography will be performed at baseline, week 12, and week 52 for efficacy monitoring. Detailed OCT angiography analysis will be performed to identify anatomical and morphological biomarkers of growth progression and disease activity. In addition to qualitative structural and morphological analysis, detailed quantitative OCT angiography analysis of the neovascular lesion using automated or manual capillary density maps and area calculation will be performed at each visit to determine the detailed microvascular response of neovascular complexes to IAI therapy.
Interventions
IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC
DEVICEoptovue angiovue
FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Sponsors
Regeneron Pharmaceuticals
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is older than 50 years of age. 2. Subject is willing to participate in the study and able to follow the study criteria and protocol. 3. The study eye is treatment naive regarding treatment of neovascular AMD. 4. Subject is willing and able to comply with clinic visits and study-related procedures. 5. Subject is able to provide signed informed consent. 6. Subject is able to understand and complete study-related questionnaires. 7. The subject is not currently involved with any other clinical study. 8. Best Corrected Visual Acuity (BCVA) with ETDRS Snellen equivalent of 20/400 or better and 20/32 or worse. 9. Sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA and fundus photography (FP). 10. Intraocular pressure (IOP) of 25mmHg or less in the study eye, with or without use of ocular hypotensive agents. 11. Prior focal corticosteroid treatment is allowed, as long as the study eye is not involved. However prior (within 90 days of Day 0) or current systemic corticosteroid therapy (oral or intravenous corticosteroid treatment) is not permitted.
Exclusion criteria
1. Any prior treatment of neovascular AMD in the eye proposed for enrollment including previous anti-vascular endothelial factor (anti-VEGF) therapy, photodynamic therapy (PDT), radiation therapy, corticosteroid treatment, surgical treatment for CNV, thermal laser treatment, and any other prior intravitreal treatment for neovascular AMD (except minerals and vitamins). 2. Known serious allergies to aflibercept, fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation, topical anesthetic, or sterilizing solution (e.g. Betadine Solution). 3. Prior or current systemic anti-VEGF therapy. 4. Pregnant or breast-feeding women. 5. Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \[IUD\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly). 6. Contraindication to pupillary dilation in study eye. 7. Any condition (including inability to read visual acuity charts, or language barrier) that may preclude subjects ability to comply with the study protocol and requirements. 8. Presence of any advanced systemic condition or end-stage disease, such as advanced Alzheimer Syndrome, end-stage cancer, etc., which will likely prevent subject from completing study. 9. Previous therapeutic radiation in the region of the study eye. 10. Prior retinal pigment epithelial (RPE) tear in study eye. 11. Prior ocular surgery (except YAG laser capsulotomy) for study within the past 90 days. 12. Anticipated ocular surgery (except YAG laser capsulotomy) for the next 12 months. 13. Prior vitrectomy in the study eye. 14. Presence of any causes of CNV and PED other than due to AMD or presence of ocular disease other than AMD affecting study eye, i.e. presumed ocular histoplasmosis syndrome, android streaks, pathologic myopia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan. | Week 24 | Area of the neovascular lesion (in millimeters\^2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change | Baseline, Week 24 | patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters). |
| Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change | Week 24, Week 52 | patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters). |
| Mean Best Corrected Visual Acuity (BCVA) | Week 24 | Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Relevant Systemic SAE | 52 weeks | relevant systemic serious adverse events |
| Number of Injections | week 24 | — |
| OCTA Neovascular Membrane Biomarker Qualitative Analysis (Sub-study) | Week 1-12 | In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including attenuation of the fringe during the initial 12 weeks |
| SD OCT Analysis of Central Macular Thickness | Baseline to week 24 | Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure. |
| OCTA Analysis of Vessel Density | 24 weeks | OCT angiography ratio of change in neovascular membrane as measured by area of the neovascular lesion in mm\^2 at baseline and week 24. Ratio of change was calculated as change from baseline divided by the baseline value. |
| OCTA Neovascular Membrane Biomarker Qualitative Analysis of Flow-void Areas(Sub-study) | Week 1-12 | In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including presence of flow-void areas during the initial 12 weeks |
| OCTA Neovascular Membrane Regression Ratio of Change | 12 weeks | OCT angiography regression of neovascular membrane as measured by ratio of change in area of the neovascular lesion (in millimeters\^2) during the initial 12 weeks |
| SD OCT Analysis of SRF Volume | week 24 and 52 | Change in volume of subretinal fluid |
| SD OCT Analysis of SHRM Volume | week 24 and 52 | Change volume of SHRM |
| Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. | week 24 | Participants with presence of cystoid macular edema |
| Pigment Epithelial Detachment (PED) Volume as Determined by SD OCT Analysis | Baseline to week 24 | Change in ratio of volume of pigment epithelial detachment (PED), calculated as change from baseline divided by baseline value. |
| PED Volume as Determined by SD OCT Analysis | Baseline to Week 52 | Change in ratio of volume of PED, calculated as change from baseline divided by baseline value. |
| PED Height as Determined by SD OCT Analysis | Baseline, week 24 | Ratio of change in height of PED, calculated as change from baseline divided by baseline value |
| OCTA Neovascular Membrane Biomarker Qualitative Analysis of Vessel Looping (Sub-study) | Week 1-12 | In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including changes in vessel looping during the initial 12 weeks |
| Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. | week 24 | Participants with presence of intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM) |
| SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) | week 52 | Participants with presence of SD OCT intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM) |
| Ocular AE | 52 weeks | ocular adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IAI Treatment Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48.
Aflibercept Ophthalmic: IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC
optovue angiovue: FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | IAI Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Mean BCVA in LogMAR | 0.32 score |
| OCTA Analysis of Lesion Area | 2.008 mm^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 2 / 26 |
| serious Total, serious adverse events | 1 / 26 |
Outcome results
Primary
Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.
Area of the neovascular lesion (in millimeters\^2)
Time frame: Week 24
Population: Participants present for 24 week assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IAI Treatment | Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan. | 1.07 mm^2 |
Primary
Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan.
Area of the neovascular lesion (in millimeters\^2)
Time frame: Week 52
Population: Participants present for 52 week assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IAI Treatment | Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan. | 0.67 mm^2 |
Secondary
Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change
patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).
Time frame: Baseline, Week 24
Population: Participants with analyzable ETDRS at both baseline \& week 24
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IAI Treatment | Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change | ≥5 ETDRS letters | 4 participants |
| IAI Treatment | Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change | ≥10 ETDRS letters | 2 participants |
| IAI Treatment | Best Corrected Visual Acuity (BCVA) -Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Change | ≥15 ETDRS letters | 0 participants |
Secondary
Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change
patients with gain of ≥5, ≥10, or ≥15 ETDRS letters. The ETDRS chart is read at 4.0 meters, and presents a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows, for a total of 14 lines (70 letters).
Time frame: Week 24, Week 52
Population: Participants with analyzable BCVA at both 24 and 52 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IAI Treatment | Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change | ≥5 ETDRS letters | 4 participants |
| IAI Treatment | Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change | ≥10 ETDRS letters | 1 participants |
| IAI Treatment | Best Corrected Visual Acuity (BCVA) -ETDRS Letter Change | ≥15 ETDRS letters | 0 participants |
Secondary
Mean Best Corrected Visual Acuity (BCVA)
Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Time frame: Week 24
Population: Participants with analyzable measure at week 24
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IAI Treatment | Mean Best Corrected Visual Acuity (BCVA) | 0.3 score |
Secondary
Mean Best Corrected Visual Acuity (BCVA)
Visual acuity (VA) was assessed at a distance of 4 meters from Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Time frame: Week 52
Population: Participants with analyzable BCVA at 52 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IAI Treatment | Mean Best Corrected Visual Acuity (BCVA) | 0.33 score |
Other Pre-specified
Number of Injections
Time frame: week 24
Population: Participants present at week 24 visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IAI Treatment | Number of Injections | 25 injections |
Other Pre-specified
Number of Injections
Time frame: week 52
Population: Participants present for week 52 visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IAI Treatment | Number of Injections | 12 injections |
Other Pre-specified
OCTA Analysis of Vessel Density
OCT angiography ratio of change in neovascular membrane as measured by area of the neovascular lesion in mm\^2 at baseline and week 24. Ratio of change was calculated as change from baseline divided by the baseline value.
Time frame: 24 weeks
Population: Participants present for both baseline and 24 week assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IAI Treatment | OCTA Analysis of Vessel Density | -0.12 ratio | Standard Deviation 2.73 |
Other Pre-specified
OCTA Neovascular Membrane Biomarker Qualitative Analysis of Flow-void Areas(Sub-study)
In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including presence of flow-void areas during the initial 12 weeks
Time frame: Week 1-12
Population: Qualitative analyses not performed due to study staff turnover and lack of expertise
Other Pre-specified
OCTA Neovascular Membrane Biomarker Qualitative Analysis of Vessel Looping (Sub-study)
In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including changes in vessel looping during the initial 12 weeks
Time frame: Week 1-12
Population: Qualitative analyses not performed due to study staff turnover and lack of expertise
Other Pre-specified
OCTA Neovascular Membrane Biomarker Qualitative Analysis (Sub-study)
In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including attenuation of the fringe during the initial 12 weeks
Time frame: Week 1-12
Population: Qualitative analyses not performed due to study staff turnover and lack of expertise
Other Pre-specified
OCTA Neovascular Membrane Regression Ratio of Change
OCT angiography regression of neovascular membrane as measured by ratio of change in area of the neovascular lesion (in millimeters\^2) during the initial 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IAI Treatment | OCTA Neovascular Membrane Regression Ratio of Change | 0.37 ratio |
Other Pre-specified
Ocular AE
ocular adverse events
Time frame: 52 weeks
Population: All participants at risk for AE
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IAI Treatment | Ocular AE | 2 events |
Other Pre-specified
PED Height as Determined by SD OCT Analysis
Ratio of change in height of PED, calculated as change from baseline divided by baseline value
Time frame: Baseline, week 52
Population: Participants present for both baseline and week 52 assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IAI Treatment | PED Height as Determined by SD OCT Analysis | 0.38 ratio |
Other Pre-specified
PED Height as Determined by SD OCT Analysis
Ratio of change in height of PED, calculated as change from baseline divided by baseline value
Time frame: Baseline, week 24
Population: Participants present for both baseline and week 24 assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IAI Treatment | PED Height as Determined by SD OCT Analysis | 0.26 ratio |
Other Pre-specified
PED Volume as Determined by SD OCT Analysis
Change in ratio of volume of PED, calculated as change from baseline divided by baseline value.
Time frame: Baseline to Week 52
Population: Participants present for both baseline and week 52 assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IAI Treatment | PED Volume as Determined by SD OCT Analysis | 0.08 ratio | Standard Deviation 0.9 |
Other Pre-specified
Pigment Epithelial Detachment (PED) Volume as Determined by SD OCT Analysis
Change in ratio of volume of pigment epithelial detachment (PED), calculated as change from baseline divided by baseline value.
Time frame: Baseline to week 24
Population: Participants present for both baseline and week 24 assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IAI Treatment | Pigment Epithelial Detachment (PED) Volume as Determined by SD OCT Analysis | 0.18 ratio | Standard Deviation 0.6 |
Other Pre-specified
Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.
Participants with presence of cystoid macular edema
Time frame: week 52
Population: Participants assessed for CME at week 52
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IAI Treatment | Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. | 3 Participants |
Other Pre-specified
Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.
Participants with presence of cystoid macular edema
Time frame: week 24
Population: Participants assessed for CME at week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IAI Treatment | Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. | 4 Participants |
Other Pre-specified
Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan.
Participants with presence of intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)
Time frame: week 24
Population: Participants present for assessment at week 24
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IAI Treatment | Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. | intraretinal | 4 Participants |
| IAI Treatment | Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. | subretinal | 9 Participants |
| IAI Treatment | Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. | SHRM | 1 Participants |
Other Pre-specified
Relevant Systemic SAE
relevant systemic serious adverse events
Time frame: 52 weeks
Population: Participants at risk for AE during study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IAI Treatment | Relevant Systemic SAE | 1 events |
Other Pre-specified
SD OCT Analysis of Central Macular Thickness
Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.
Time frame: Baseline to week 52
Population: Participants present for both baseline and week 52 assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IAI Treatment | SD OCT Analysis of Central Macular Thickness | 0.07 ratio | Standard Deviation 0.25 |
Other Pre-specified
SD OCT Analysis of Central Macular Thickness
Ratio of change in SD OCT central macular thickness, calculated as change between visits divided by baseline measure.
Time frame: Baseline to week 24
Population: Participants present for both baseline and week 24 assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IAI Treatment | SD OCT Analysis of Central Macular Thickness | 0.08 ratio | Standard Deviation 0.27 |
Other Pre-specified
SD OCT Analysis of SHRM Volume
Change volume of SHRM
Time frame: week 24 and 52
Population: Fluid volume measures not performed due to study staff turnover and lack of expertise
Other Pre-specified
SD OCT Analysis of SRF Volume
Change in volume of subretinal fluid
Time frame: week 24 and 52
Population: Fluid volume measures not performed due to study staff turnover and lack of expertise
Other Pre-specified
SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM)
Participants with presence of SD OCT intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM)
Time frame: week 52
Population: Participants present for assessment at 52 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IAI Treatment | SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) | intraretinal | 3 Participants |
| IAI Treatment | SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) | subretinal | 6 Participants |
| IAI Treatment | SD OCT Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) | SHRM | 0 Participants |