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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IAI Treatment | Experimental | Intravitreal injection of aflibercept 2 mg/0.05 ml 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 Primary Investigator (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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept Ophthalmic | Drug | IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan. | Area of the neovascular lesion (in millimeters^2) | Week 24 |
| Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan. | Area of the neovascular lesion (in millimeters^2) | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Presence of Intraretinal and Subretinal Fluid, and Subretinal Hyper-Reflective Material (SHRM) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stein Eye Institute of UCLA | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15078664 | Background | Congdon N, O'Colmain B, Klaver CC, Klein R, Munoz B, Friedman DS, Kempen J, Taylor HR, Mitchell P; Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):477-85. doi: 10.1001/archopht.122.4.477. | |
| 25170575 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan. | Area of the neovascular lesion (in millimeters^2) | Participants present for 24 week assessment | Posted | Mean | Full Range | mm^2 | Week 24 |
|
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Sarraf | Stein Eye Institute of UCLA | 310-825-7836 | DSarraf@ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2018 | Aug 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| optovue angiovue | Device | FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI. |
|
|
| 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). | Week 24, Week 52 |
| 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. | Week 24 |
| 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. | Week 52 |
Participants with presence of intraretinal and subretinal fluid, and Subretinal Hyper-Reflective Material (SHRM) |
| week 24 |
| 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) | week 52 |
| Ocular AE | ocular adverse events | 52 weeks |
| Relevant Systemic SAE | relevant systemic serious adverse events | 52 weeks |
| Number of Injections | week 24 |
| Number of Injections | week 52 |
| 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 | Week 1-12 |
| 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. | Baseline to week 24 |
| 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. | Baseline to week 52 |
| 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. | 24 weeks |
| 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 | Week 1-12 |
| 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 | Week 1-12 |
| SD OCT Analysis of SRF Volume | Change in volume of subretinal fluid | week 24 and 52 |
| SD OCT Analysis of SHRM Volume | Change volume of SHRM | week 24 and 52 |
| Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. | Participants with presence of cystoid macular edema | week 24 |
| Presence of CME (Cystoid Macular Edema) on Spectral Domain Optical Coherence Tomography (SD-OCT) Scan. | Participants with presence of cystoid macular edema | week 52 |
| 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. | Baseline to week 24 |
| PED Volume as Determined by SD OCT Analysis | Change in ratio of volume of PED, calculated as change from baseline divided by baseline value. | Baseline to Week 52 |
| PED Height as Determined by SD OCT Analysis | Ratio of change in height of PED, calculated as change from baseline divided by baseline value | Baseline, week 24 |
| PED Height as Determined by SD OCT Analysis | Ratio of change in height of PED, calculated as change from baseline divided by baseline value | Baseline, week 52 |
| Solomon SD, Lindsley K, Vedula SS, Krzystolik MG, Hawkins BS. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014 Aug 29;8(8):CD005139. doi: 10.1002/14651858.CD005139.pub3. |
| 26164826 | Background | Kuehlewein L, Bansal M, Lenis TL, Iafe NA, Sadda SR, Bonini Filho MA, De Carlo TE, Waheed NK, Duker JS, Sarraf D. Optical Coherence Tomography Angiography of Type 1 Neovascularization in Age-Related Macular Degeneration. Am J Ophthalmol. 2015 Oct;160(4):739-48.e2. doi: 10.1016/j.ajo.2015.06.030. Epub 2015 Jul 9. |
| 26502007 | Background | Kuehlewein L, Dansingani KK, de Carlo TE, Bonini Filho MA, Iafe NA, Lenis TL, Freund KB, Waheed NK, Duker JS, Sadda SR, Sarraf D. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY OF TYPE 3 NEOVASCULARIZATION SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2015 Nov;35(11):2229-35. doi: 10.1097/IAE.0000000000000835. |
| 26457399 | Background | Miere A, Querques G, Semoun O, El Ameen A, Capuano V, Souied EH. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN EARLY TYPE 3 NEOVASCULARIZATION. Retina. 2015 Nov;35(11):2236-41. doi: 10.1097/IAE.0000000000000834. |
| 26441269 | Background | El Ameen A, Cohen SY, Semoun O, Miere A, Srour M, Quaranta-El Maftouhi M, Oubraham H, Blanco-Garavito R, Querques G, Souied EH. TYPE 2 NEOVASCULARIZATION SECONDARY TO AGE-RELATED MACULAR DEGENERATION IMAGED BY OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2212-8. doi: 10.1097/IAE.0000000000000773. |
| 24679442 | Background | Jia Y, Bailey ST, Wilson DJ, Tan O, Klein ML, Flaxel CJ, Potsaid B, Liu JJ, Lu CD, Kraus MF, Fujimoto JG, Huang D. Quantitative optical coherence tomography angiography of choroidal neovascularization in age-related macular degeneration. Ophthalmology. 2014 Jul;121(7):1435-44. doi: 10.1016/j.ophtha.2014.01.034. Epub 2014 Mar 27. |
| 26457397 | Background | Miere A, Semoun O, Cohen SY, El Ameen A, Srour M, Jung C, Oubraham H, Querques G, Souied EH. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY FEATURES OF SUBRETINAL FIBROSIS IN AGE-RELATED MACULAR DEGENERATION. Retina. 2015 Nov;35(11):2275-84. doi: 10.1097/IAE.0000000000000819. |
| 26201877 | Background | Coscas G, Lupidi M, Coscas F, Francais C, Cagini C, Souied EH. Optical coherence tomography angiography during follow-up: qualitative and quantitative analysis of mixed type I and II choroidal neovascularization after vascular endothelial growth factor trap therapy. Ophthalmic Res. 2015;54(2):57-63. doi: 10.1159/000433547. Epub 2015 Jul 17. |
| 25887628 | Background | Spaide RF. Optical Coherence Tomography Angiography Signs of Vascular Abnormalization With Antiangiogenic Therapy for Choroidal Neovascularization. Am J Ophthalmol. 2015 Jul;160(1):6-16. doi: 10.1016/j.ajo.2015.04.012. Epub 2015 Apr 14. |
| 24084500 | Background | Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, Ho AC, Ogura Y, Simader C, Jaffe GJ, Slakter JS, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Sowade O, Zeitz O, Norenberg C, Sandbrink R, Heier JS. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014 Jan;121(1):193-201. doi: 10.1016/j.ophtha.2013.08.011. Epub 2013 Sep 29. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mean BCVA in LogMAR | Best Corrected Visual acuity (BCVA) 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. | Measure includes all participants with analyzable baseline BCVA | Mean | Full Range | score |
|
| OCTA Analysis of Lesion Area | Mean | Full Range | mm^2 |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Area of Lesion Measured by Optical Coherence Tomography Angiography (OCTA) Scan. | Area of the neovascular lesion (in millimeters^2) | Participants present for 52 week assessment | Posted | Mean | Full Range | mm^2 | Week 52 |
|
|
|
| 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). | Participants with analyzable ETDRS at both baseline & week 24 | Posted | Number | participants | Baseline, Week 24 |
|
|
|
| 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). | Participants with analyzable BCVA at both 24 and 52 weeks | Posted | Number | participants | Week 24, Week 52 |
|
|
|
| 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. | Participants with analyzable measure at week 24 | Posted | Mean | Full Range | score | Week 24 |
|
|
|
| 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. | Participants with analyzable BCVA at 52 weeks | Posted | Mean | Full Range | score | Week 52 |
|
|
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| 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 | Posted | Mean | Inter-Quartile Range | ratio | 12 weeks |
|
|
|
| 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) | Participants present for assessment at week 24 | Posted | Count of Participants | Participants | week 24 |
|
|
|
| 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) | Participants present for assessment at 52 weeks | Posted | Count of Participants | Participants | week 52 |
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| Other Pre-specified | Ocular AE | ocular adverse events | All participants at risk for AE | Posted | Number | events | 52 weeks |
|
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| Other Pre-specified | Relevant Systemic SAE | relevant systemic serious adverse events | Participants at risk for AE during study | Posted | Number | events | 52 weeks |
|
|
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| Other Pre-specified | Number of Injections | Participants present at week 24 visit | Posted | Number | injections | week 24 |
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| Other Pre-specified | Number of Injections | Participants present for week 52 visit | Posted | Number | injections | week 52 |
|
|
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| 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 | Qualitative analyses not performed due to study staff turnover and lack of expertise | Posted | Week 1-12 |
|
|
| 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. | Participants present for both baseline and week 24 assessment | Posted | Mean | Standard Deviation | ratio | Baseline to week 24 |
|
|
|
| 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. | Participants present for both baseline and week 52 assessment | Posted | Mean | Standard Deviation | ratio | Baseline to week 52 |
|
|
|
| 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. | Participants present for both baseline and 24 week assessment | Posted | Mean | Standard Deviation | ratio | 24 weeks |
|
|
|
| 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 | Qualitative analyses not performed due to study staff turnover and lack of expertise | Posted | Week 1-12 |
|
|
| 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 | Qualitative analyses not performed due to study staff turnover and lack of expertise | Posted | Week 1-12 |
|
|
| Other Pre-specified | SD OCT Analysis of SRF Volume | Change in volume of subretinal fluid | Fluid volume measures not performed due to study staff turnover and lack of expertise | Posted | week 24 and 52 |
|
|
| Other Pre-specified | SD OCT Analysis of SHRM Volume | Change volume of SHRM | Fluid volume measures not performed due to study staff turnover and lack of expertise | Posted | week 24 and 52 |
|
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| 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 | Participants assessed for CME at week 24 | Posted | Count of Participants | Participants | week 24 |
|
|
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| 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 | Participants assessed for CME at week 52 | Posted | Count of Participants | Participants | week 52 |
|
|
|
| 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. | Participants present for both baseline and week 24 assessment | Posted | Mean | Standard Deviation | ratio | Baseline to week 24 |
|
|
|
| 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. | Participants present for both baseline and week 52 assessment | Posted | Mean | Standard Deviation | ratio | Baseline to Week 52 |
|
|
|
| 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 | Participants present for both baseline and week 24 assessment | Posted | Mean | Inter-Quartile Range | ratio | Baseline, week 24 |
|
|
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| 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 | Participants present for both baseline and week 52 assessment | Posted | Mean | Inter-Quartile Range | ratio | Baseline, week 52 |
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| 0 |
| 26 |
| 1 |
| 26 |
| 2 |
| 26 |
| Pneumonia | Infections and infestations | Systematic Assessment |
|
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