A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Tr… (NCT05811351) | Clinical Trial Compass
CompletedPhase 2
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)
United States305 participantsStarted 2023-03-06
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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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
What they're measuring
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
2
United States (U.S.) Specific: Rate of Change in Untransformed GA Lesion Area in the Study Eye