TRIALS
PARASOL: safety and efficacy of a single gene therapy injection in patients with atrophic AMD
STATUS:
DESCRIPTION
Phase IIb, randomized, double-masked study that will evaluate the safety and efficacy of a single injection of the investigational drug JNJ-81201887 compared to placebo (sham injection) in patients with geographic atrophy secondary to age-related macular degeneration (AMD).
Objectives
The primary objective of this study is to evaluate changes in the growth of the fundus lesion. Secondary objectives include assessing changes in visual function, the retina, and quality of life.
Drug
The investigational gene therapy in this study, JNJ-81201887 (AAVCAGsCD59), is a recombinant adeno-associated virus serotype 2 (rAAV2) carrying a transgene that encodes for sCD59.
Population
INCLUSION CRITERIA:
Patients aged 60 or older with dry AMD and a non-subfoveal atrophic area between 2.5 mm² and 17.5 mm². These and other medical criteria will be evaluated during the screening visit.
Duration
Associated Pathologies
No results found.
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