A Phase 2 interventional study of JNJ-81201887 and Prednisone in Geographic Atrophy, sponsored by Janssen Research & Development, LLC. Completed at 162 sites in 17 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
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.
173 studies on the registry are indexed under Geographic Atrophy; 44 are open to participants now.
This study's enrollment of 305 is above the median of 60 across 131 interventional studies indexed under Geographic Atrophy.
Browse Geographic Atrophy studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single low dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
Drug: JNJ-81201887 · Drug: Prednisone · Drug: Triamcinolone
Participants will receive a single high dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
Drug: JNJ-81201887 · Drug: Prednisone · Drug: Triamcinolone
Participants will receive sham procedure that matches the single JNJ21801887 injection on Day 4, a sham procedure that matches the long acting periocular triamcinolone (corticosteroid injection) on Day 4 and a 20-day placebo matching oral prednisone starting on Day 1.
Other: Placebo · Other: Sham Procedure
JNJ-81201887 will be administered as intravitreal injection.
Also known as: AAVCAGsCD59
Prednisone will be administered as oral capsule.
Prednisone matching placebo will be administered as oral capsule.
Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice.
Sham injections matching to single JNJ-81201887 injection and matching to corticosteroid (triamcinolone) periocular injection will be administered.
Global: Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at 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).
Time frame: Baseline and Month 18
United States (U.S.) Specific: Rate of Change in Untransformed GA Lesion Area in the Study Eye
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.
Time frame: Baseline to Month 18
Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18
Best corrected LLVA will be assessed using the early treatment diabetic retinopathy study (ETDRS) chart at a starting distance of 4 meter.
Time frame: Baseline and Month 18
Change From Baseline in Reading Speed at 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.
Time frame: Baseline and Month 18
Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18
Change from baseline retinal sensitivity by MAIA will be reported.
Time frame: Baseline and Month 18
Change From Baseline in Best Corrected Visual Acuity (BCVA) at 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.
Time frame: Baseline and Month 18
Change From Baseline in Functional Reading Independence (FRI) Index at 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.
Time frame: Baseline and Month 18
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at 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.
Time frame: Baseline and Month 18
Showing the first 100 of 162 sites across 17 countries.
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen Research & Development, LLC