TerminatedPhase 2

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

Stopped: Terminated for interim analysis demonstrating futility (trial highly unlikely to meet efficacy outcome). The trial is not ending early because of medical problems or concerns.

United States, Australia, France98 participantsStarted 2019-04-26

Plain-language summary

The purpose of this clinical study was 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).

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Able and willing to give written informed consent
. Age ≥55 years
. 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 (except if the subject is monocular)
. Have GA lesion(s) total size between or equal to 1.25mm2 to 17.5mm2 in the study eye
. The GA lesion(s) in the study eye must reside completely within the FAF image
. Up to 25% of the enrolled study population are permitted to have CNV in the fellow eye, defined as either:
. Non-exudative/sub-clinical fellow eye CNV identified at Screening, or

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Change From Baseline to Week 48 in Geographic Atrophy (GA) - Part 1

Timeframe: Baseline, Weeks 12, 24, 36, and 48

Trial details

NCT IDNCT04437368

SponsorGyroscope Therapeutics Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-05

Results submitted2025-03-07

View on ClinicalTrials.gov More Dry Age-related Macular Degeneration trials

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Able and willing to give written informed consent
. Age ≥55 years
. 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 (except if the subject is monocular)
. Have GA lesion(s) total size between or equal to 1.25mm2 to 17.5mm2 in the study eye
. The GA lesion(s) in the study eye must reside completely within the FAF image
. Up to 25% of the enrolled study population are permitted to have CNV in the fellow eye, defined as either:
. Non-exudative/sub-clinical fellow eye CNV identified at Screening, or

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria