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)

• Status: Recruiting
• Trial end date: 2025-09-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Prednisone; Triamcinolone

Criteria

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 measuring 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)

• GA can be photographed in its entirety by FAF, using a 30 degree image centered on the fovea

• 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