Trials / Recruiting

RecruitingNCT07392255

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

A First in Human Phase 1 / 2 Multi-center Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of CTx001 Administered Via a Single Subretinal Injection in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Status: Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 75 (estimated)

Sponsor: Complement Therapeutics · Industry
Sex: All
Age: 55 Years
Healthy volunteers: Not accepted

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.

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Interventions

Type	Name	Description
GENETIC	CTx001	Subretinal administration of CTx001

Timeline

Start date: 2025-12-30
Primary completion: 2028-05-31
Completion: 2032-06-30
First posted: 2026-02-06
Last updated: 2026-03-17

Locations

3 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07392255. Inclusion in this directory is not an endorsement.