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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)
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
22-5125
Category
Eye/Ocular Disorders
Principal Investigator
Contact
Location
- UCLA Westwood