One-time subretinal CTx001 injection for geographic atrophy from AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Opti-GAIN is a phase 1/2 interventional trial testing a single subretinal injection of CTx001 in people with bilateral geographic atrophy secondary to AMD. Participants must meet imaging, lesion size, visual acuity, and retinal sensitivity criteria and will be followed closely with functional and structural eye tests. Safety, tolerability, and signs of efficacy will be measured regularly for two years, with long-term safety follow-up annually for up to five years. The trial excludes eyes with non-AMD retinal disease, current or prior choroidal neovascularization, and prior intraocular procedures that could confound outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Midwest Eye Institute
  Carmel, Indiana, United States Recruiting
• Sierra Eye Associates
  Reno, Nevada, United States Recruiting
• Retina Foundation of the Southwest
  Dallas, Texas, United States Recruiting
• Gundersen Health System
  La Crosse, Wisconsin, United States Recruiting
• Gloucestershire Royal Hospital
  Gloucester, Gloucestershire, United Kingdom Recruiting
• Moorfields Eye Hospital
  London, London, United Kingdom Recruiting

Study contacts

• Study coordinator: Muhammad Ali Memon
• Email: clinicaltrials@complementtx.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Transcorneal electrical stimulation to slow geographic atrophy

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• FWY003 versus placebo for geographic atrophy from age-related macular degeneration

  This study will test whether injections of FWY003 can slow the growth of geographic atrophy in people aged 50 and older with AMD.

  Recruiting at 65 sites Phase 2 Novartis · Huntington Beach, California and 64 other locations · NCT07441642

• APL-3007 combined with Syfovre (pegcetacoplan) for geographic atrophy from age-related macular degeneration

  This trial will test whether adding APL-3007 to ongoing Syfovre (pegcetacoplan) injections can slow geographic atrophy progression in people aged 60 and older already receiving Syfovre.

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• Short-term progression of geographic atrophy in people with age-related macular degeneration

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  Recruiting at 17 sites Complement Therapeutics · Mountain View, California and 18 other locations · NCT07144137

• ADX-038 for geographic atrophy due to age-related macular degeneration

  This phase 2 study will test whether ADX-038 can slow geographic atrophy in people with age-related macular degeneration compared with placebo while monitoring safety and drug levels.

  Recruiting at 40 sites Phase 2 ADARx Pharmaceuticals, Inc. · Gilbert, Arizona and 82 other locations · NCT06990269

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.