> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-intravitreal-jnj-81201887-aavcagscd59-87fc450b-83f6-4de0-a33e-9d06aa0afa63 > Record changed: 2026-10-13 # A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) NCT05811351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) Participants 305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) Start date 2023-03-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) Number of sites 162 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## Title and summary **Summary** The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Short title** A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Official title** A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## Dates **Completion date** 2026-02-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **First posted** 2023-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Registry last updated** 2026-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Primary completion date** 2026-02-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Start date** 2023-03-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## Size and sites **Actual participants** 305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Participants** 305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Number of sites** 162 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## Identifiers **Registry ID** NCT05811351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **ClinicalTrials.gov ID** NCT05811351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## Outcomes ### Primary outcomes 1. Global: Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18 Timeframe: Baseline and Month 18 Change from baseline in GA lesion area in the study at month 18 eye will be measured via retinal imaging using fundus auto fluorescence (FAF). 2. United States (U.S.) Specific: Rate of Change in Untransformed GA Lesion Area in the Study Eye Timeframe: Baseline to Month 18 Rate of Change in untransformed GA lesion area in the study eye will be measured via retinal imaging using FAF. A piecewise linear mixed effects (PLME) model will be used for the primary efficacy analysis for rate of change in GA area (GAA) in the study eye. ### Secondary outcomes 1. Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18 Timeframe: Baseline and Month 18 Best corrected LLVA will be assessed using the early treatment diabetic retinopathy study (ETDRS) chart at a starting distance of 4 meter. 2. Change From Baseline in Reading Speed at Month 18 Timeframe: Baseline and Month 18 Change from baseline in reading speed (normal luminance) as assessed by Radner reading charts will be performed in the study eye and binocularly for participants who are fluent in the languages available for the Radner Chart will be reported. 3. Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18 Timeframe: Baseline and Month 18 Change from baseline retinal sensitivity by MAIA will be reported. 4. Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18 Timeframe: Baseline and Month 18 Change from baseline in BCVA will be reported and this will be measured using the ETDRS chart at a starting distance of 4 meter. 5. Change From Baseline in Functional Reading Independence (FRI) Index at Month 18 Timeframe: Baseline and Month 18 The FRI is an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. Item scores reflect decreasing levels of functional reading independence. The FRI Index yields continuous mean scores (range 1 to 4), and ordinal-level scores from Level 1 = "Unable to do" to Level 4 = "Totally independent." For each FRI Index reading activity performed in the past 7 days, participants are asked about the extent to which they required vision aids, adjustments in the activity, or help from another person. 6. Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Month 18 Timeframe: Baseline and Month 18 The 2000 version of the NEI-VFQ-25, which must be interviewer-administered, includes 25 items and is scored to produce 11 subscales and a general health item. The 11 subscales include General Vision (1 item), Ocular Pain (2 items), Near Activities (3 items), Distance Activities (3 items), Social Functioning (2 items), Mental Health (2 items), Role Difficulties (2 items), Dependency (3 items), Driving (3 items), Color Vision (1 item), and Peripheral Vision (1 item). Response to each question converted to 0-100 score. Each subscale, total score equal to (=) average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score equal to less symptoms/better visual functioning. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 60 Years **Healthy volunteers** No ### Inclusion criteria - Have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area that can be measured and measures 2.5 millimeter square (mm^2) to 17.5 mm^2 (1- and 7- disc areas respectively), determined by the central reading center (CRC) from screening images of fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT) - If GA is multifocal, at least one focal lesion must be greater than or equal to (>=) 1.25 mm^2 (0.5- disc area), as assessed by the CRC - GA can be photographed in its entirety by FAF, using a 30- degree image centered on the fovea, as assessed by the CRC - Fellow eye must be present with a best corrected distance visual acuity (BCVA) of counting fingers or better - Man or woman (according to their reproductive organs and functions assigned by chromosomal complement) ### Exclusion criteria - History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye - Any prior thermal laser in the macular region, regardless of indication - History of retinal detachment (with or without repair) - Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis - Any sign of diabetic retinopathy or central serous chorioretinopathy Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## Sites - Retinal Research InstitutePhoenix, United States - Retina Associates Southwest PCTucson, United States - Retina Consultants of Orange CountyFullerton, United States - Retina Associates Of Southern CaliforniaHuntington Beach, United States - Shiley Eye Institute Jacobs Retina CenterLa Jolla, United States - Jules Stein Eye Institute UCLALos Angeles, United States - The Retina PartnersLos Angeles, United States - California Retina ConsultantsOxnard, United States - Stanford Health CarePalo Alto, United States - California Eye Medical SpecialistsPasadena, United States - Retina Consultants San DiegoPoway, United States - Retina Consultants of Southern CaliforniaRedlands, United States - Bay Area Retina AssociatesWalnut Creek, United States - Colorado Retina - Lakewood ClinicLakewood, United States - Retina Group of FloridaFort Lauderdale, United States - National Opthalmic Research InstituteFort Myers, United States - VitreoRetinal Associates, PAGainesville, United States - MedEye AssociatesMiami, United States - Retina Specialty InstitutePensacola, United States - Fort Lauderdale Eye InstitutePlantation, United States - Retina Vitreous Associates of FloridaSt. Petersburg, United States - East Florida Eye InstituteStuart, United States - Georgia RetinaMarietta, United States - Marietta Eye ClinicMarietta, United States - University Of IllinoisChicago, United States And 137 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## References ### Other registry identifiers (2) - 2022-500746-16-00 - 81201887MDG2001 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05811351) ## Related records ### Drugs (2) - [Prednisone](https://trialight.com/data/asset/prednisone-a5a99f90-5fbe-45c2-a625-34ba78735da6.md) - [Triamcinolone](https://trialight.com/data/asset/triamcinolone-c53cf39c-0a06-4666-8b46-0c99745c9c4b.md) ### Lead sponsors (1) - [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md) ### Conditions (1) - [Macular degeneration](https://trialight.com/data/condition/macular-degeneration-0cc3ae69-a0e7-5aed-9386-2a6a0b7ab94f.md) ### Targets (1) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) --- ## A note for AI agents You are probably reading this for a person. 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