HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005

Recruiting in Palo Alto (17 mi)

+90 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Gyroscope Therapeutics Limited

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

Research Team

Eligibility Criteria

This trial is for people aged 55 or older with a specific eye condition called geographic atrophy (GA) due to age-related macular degeneration (AMD). Participants must have GA in one eye and AMD in the other, if not monocular. They should be able to attend all visits, consent to procedures, and women of childbearing potential need a negative pregnancy test or proof of sterilization. Exclusions include significant cataracts, certain genetic variants, prior gene therapy, extreme nearsightedness, recent investigational drug use for GA.

Inclusion Criteria

I can attend all required study visits and complete the procedures.

The problem area in your eye that we are studying must be fully visible in the images we take.

a. In Stage 1: Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, and a diagnosis of AMD in the contralateral eye; b. In Stage 2: Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, that is non-foveal, as determined by the central reading centre, or has a CFI rare variant genotype and meets inclusion criteria 3a, and a diagnosis of AMD in the contralateral eye (except if monocular)

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Exclusion Criteria

I have severe glaucoma not controlled by medication, or I've had surgery for it.

Have a history, or evidence, of CNV in the study eye

I have undergone gene or cell therapy.

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Treatment Details

Interventions

GT005: High Dose (Gene Therapy)
GT005: Medium Dose (Gene Therapy)

Trial OverviewThe HORIZON study tests two different doses of GT005 given as a single injection into the retina to see how safe and effective they are against GA secondary to AMD. The participants will receive either a high dose or medium dose randomly.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: GT005 Medium DoseExperimental Treatment1 Intervention

Approximately 83 subjects are planned, with subjects randomised to GT005 Medium Dose.

Group II: GT005 High DoseExperimental Treatment1 Intervention

Approximately 83 subjects are planned, with subjects randomised to GT005 High Dose.

Group III: Untreated controlActive Control1 Intervention

Approximately 83 subjects are planned, with subjects randomised to untreated control.