CTx001 for Macular Degeneration

(Opti-GAIN Trial)

Overseen By Muhammad Ali Memon

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Complement Therapeutics

Must not be taking: Complement inhibitors

Disqualifiers: Wet AMD, Glaucoma, Diabetic retinopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

The Opti-GAIN trial is for adults with bilateral geographic atrophy due to age-related macular degeneration (AMD). Participants must meet specific criteria regarding the size of the lesion, visual acuity, retinal sensitivity, and have historical eye imaging available. They should be able to navigate safely with their fellow eye and agree to study procedures.

Inclusion Criteria

I meet the age requirement for the study.

I have previous SD-OCT images available for review.

My other eye sees well enough for me to move around safely.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subretinal injection of CTx001

1 day

1 visit (in-person)

Initial Follow-up

Safety and efficacy are measured at regular intervals

2 years

Regular visits (in-person)

Long-term Follow-up

Long-term safety is assessed annually

3 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CTx001

Trial Overview

This trial tests CTx001 administered through a single subretinal injection in patients with GA secondary to AMD. The main goals are to assess its safety, tolerability, and effectiveness over two years, followed by annual checks for up to five additional years.

How Is the Trial Designed?

Group I: Cohort 5 Experimental Treatment 1 Intervention

Expansion of a second dose selected from Cohort 1-3

Group II: Cohort 4 Experimental Treatment 1 Intervention

Expansion of a dose selected from Cohort 1-3

Group III: Cohort 3 Experimental Treatment 1 Intervention

High Dose

Group IV: Cohort 2 Experimental Treatment 1 Intervention

Medium Dose

Group V: Cohort 1 Experimental Treatment 1 Intervention

Low Dose

Who Is Running the Clinical Trial?

Complement Therapeutics

Lead Sponsor

Trials

1

Recruited

250+