🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT07392255
Recruiting Phase 1/2

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

NCT07392255 · tracked via the Priya Life Science UK tracker
Sponsor
Complement Therapeutics
Phase
Phase 1/2
Started
2025-12-30
Last updated
2026-06-22

Condition(s) studied

Geographic Atrophy Secondary to Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

CTx001

CTx001: Subretinal administration of CTx001

Study 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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Meet protocol-defined age eligibility Have bilateral geographic atrophy secondary to AMD, confirmed by the Reading Center Meet baseline lesion size requirements, as assessed by fundus autofluorescence imaging Meet best-corrected visual acuity and low-luminance visual acuity criteria, as measured by ETDRS charts Meet retinal sensitivity criteria, as measured by microperimetry Have sufficient fellow-eye visual function to ensure navigational vision Have adequate historical SD-OCT imaging available for longitudinal assessment Meet reproductive status and contraception requirements, where applicable Be able and willing to provide informed consent and comply with study procedures Exclusion Criteria: Macular atrophy or retinal disease not attributable to AMD Evidence of current or prior choroidal neovascularization (wet AMD) Prior intraocular, macular, or retinal surgery or laser treatment that may confound assessments Prior AMD-directed or intravitreal therapy in the study eye, except permitted supplements Prior exposure to complement inhibitor therapies Ocular conditions, infections, inflammation, or media opacities that interfere with safety or retinal imaging Uncontrolled glaucoma, diabetic retinopathy, or clinically significant refractive error Aphakia or compromised posterior capsule, except as permitted by protocol Systemic medical or psychiatric conditions that may increase risk or limit compliance Recent participation in another interventional clinical study or exposure to investigational therapies Any condition that, in the investigator's judgment, poses unacceptable risk or precludes safe participation

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Midwest Eye Institute Carmel Indiana Recruiting
Sierra Eye Associates Reno Nevada Recruiting
Retina Foundation of the Southwest Dallas Texas Recruiting
Gundersen Health System La Crosse Wisconsin Recruiting
The Retina Clinic London London London Recruiting

More Complement Therapeutics trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07392255 on ClinicalTrials.gov ↗ ← All trials in the UK