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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
305
JNJ-81201887 will be administered as intravitreal injection.
Prednisone will be administered as oral capsule.
Prednisone matching placebo will be administered as oral capsule.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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
...and 152 more locations
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