drugset / Trial / NCT07392255

An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)

NCT07392255

Phase 1/2 Recruiting 75 enrolled Complement Therapeutics
RandomizedSequentialOpen-labelTreatment

Summary

This is a clinical study to evaluate the safety, tolerability and efficacy of CTx001, administered via a single subretinal injection, for GA (secondary to AMD). Safety and efficacy will be measured at regular intervals for 2 years after which long-term safety will be assessed annually for up to 5 years.

Timeline

Start
2025-12-30
Primary completion
2028-05-31
Completion
2032-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject EXAGAMGLOGENE AUTOTEMCEL CRISPR / gene editing Other