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)
Completed · Phase 2 · Has a placebo group
Conditions studied: Geographic Atrophy
In brief
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.
Key facts
- Study ID
- NCT05811351
- Run by
- Janssen Research & Development, LLC
- People needed
- 305
- Starts
- 2023-03-06
- Expected to finish
- 2026-02-23
- Last updated by the study team
- 2026-03-13
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Oftalmika — Bydgoszcz, Poland
- Uno Med — Tarnów, Poland
- Retina Consultants of Southern California — Redlands, California, United States
- Retinal Research Institute — Phoenix, Arizona, United States
- Retina Associates Southwest PC — Tucson, Arizona, United States
- Retina Consultants of Orange County — Fullerton, California, United States
- Retina Associates Of Southern California — Huntington Beach, California, United States
- Shiley Eye Institute Jacobs Retina Center — La Jolla, California, United States
- Jules Stein Eye Institute UCLA — Los Angeles, California, United States
- The Retina Partners — Los Angeles, California, United States
- California Retina Consultants — Oxnard, California, United States
- Stanford Health Care — Palo Alto, California, United States
- California Eye Medical Specialists — Pasadena, California, United States
- Retina Consultants San Diego — Poway, California, United States
- Bay Area Retina Associates — Walnut Creek, California, United States
- Colorado Retina - Lakewood Clinic — Lakewood, Colorado, United States
- Retina Group of Florida — Fort Lauderdale, Florida, United States
- National Opthalmic Research Institute — Fort Myers, Florida, United States
- VitreoRetinal Associates, PA — Gainesville, Florida, United States
- MedEye Associates — Miami, Florida, United States
- Retina Specialty Institute — Pensacola, Florida, United States
- Fort Lauderdale Eye Institute — Plantation, Florida, United States
- Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
- East Florida Eye Institute — Stuart, Florida, United States
- Oculomedica — Bydgoszcz, Poland
Full record on ClinicalTrials.gov
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