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Gene therapy shot for dry AMD shows promise but trial halted early

NCT ID NCT04566445

Disease control Sponsor: Gyroscope Therapeutics Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a single injection of GT005, a gene therapy, in 255 people with geographic atrophy from dry age-related macular degeneration. The goal was to see if it could slow the growth of blind spots in the eye. The trial was terminated early, so we have less data than hoped, but results may still inform future treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GT005 (a gene therapy injected into the eye to help regulate the immune system)
What this could lead to
If successful, this could point toward a treatment that slows or stops vision loss from dry age-related macular degeneration.
What could go wrong
The trial was terminated early, so results are limited. Gene therapy for the eye carries risks like inflammation or retinal damage, and it is unclear if it will work in larger populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

255 people

The number who actually took part.

Started

Sep 2020

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able and willing to give written informed consent 2. Age ≥55 years 3. 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) 4. GA lesion(s) within an acceptable size on FAF, in the study eye 5. The GA lesion in the study eye must reside completely within the FAF image 6. Up to 25% of the enrolled study population are permitted to have CNV in the fellow eye 7. Have a BCVA of ≥24 letters (6/95 or 20/320 Snellen acuity equivalent), using ETDRS charts, in the study eye 8. a. In Stage 1: Meet one of the pre-specified AMD genetic subgroup criteria; b. In Stage 2: Genotyping is not required for study eligibility 9. Able to attend all study visits and complete the study procedures 10. Women of child-bearing potential must have a negative pregnancy test within 2 weeks prior to randomisation (not required for postmenopausal women) or provide documentation of being surgically sterilised Exclusion Criteria: 1. a. In Stage 1: Carriers of excluded genetic variants; b. In Stage 2: Subjects are excluded if they have a clinical diagnosis of Stargardt Disease or other retinal dystrophies 2. Have a history, or evidence, of CNV in the study eye 3. Presence of moderate/severe or worse non-proliferative, diabetic retinopathy in the study eye 4. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye 5. History of intraocular surgery in the study eye within 12 weeks prior to Visit 1 6. Have clinically significant cataract that may require surgery during the study period in the study eye 7. Presence of moderate to severe glaucomatous optic neuropathy, uncontrolled intraocular pressure (IOP), despite use of two or more topical agents; or a history of glaucoma-filtering or valve surgery 8. Axial myopia of greater than -8 diopters in the study eye 9. Have received any investigational product for the treatment of GA within the past 6 months or 5 half-lives (whichever is longer), other than nutritional supplements such as the age-related eye disease study (AREDS) formula 10. Have received a gene or cell therapy at any time. 11. Have a contraindication to the protocol specified corticosteroid regimen 12. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant 13. Active malignancy within the past 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with a stable prostate-specific antigen (PSA) ≥ 12 months 14. Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration dry age related macular degeneration eye disorder Geographic Atrophy primary anetoderma retinal degeneration retinal disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry age-related macular degeneration

Contacts and locations

Locations

  • Associated Retinal Consultants PC

    Royal Oak, Michigan, 48073, United States

  • Austin Research Center for Retina, PLLC

    Austin, Texas, 78705, United States

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136, United States

  • Byers Eye Institute at Stanford

    Palo Alto, California, 94303, United States

  • CHU Dijon - Hopital Mitterrand

    Dijon, 21000, France

  • CHU de Nantes - Hôtel-Dieu

    Nantes, 44093, France

  • Casey Eye Institute - OHSU

    Portland, Oregon, 97239, United States

  • Centre Paradis Monticelli

    Marseille, 13008, France

  • Charles Retina Institute

    Germantown, Tennessee, 38138, United States

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Baviera

    Madrid, 28046, Spain

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008, Spain

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Department of Ophthalmology UW Medicine

    Seattle, Washington, 98104-2499, United States

  • Duke Eye Center

    Durham, North Carolina, 27705, United States

  • Erie Retinal Surgery ,INC

    Erie, Pennsylvania, 16507, United States

  • Georgia Retina PC

    Marietta, Georgia, 30060, United States

  • Illinois Retina Associates

    Chicago, Illinois, 60657, United States

  • Instituto de microcirugía ocular

    Barcelona, 08035, Spain

  • Internationale Innovative Ophthalmochirurgie

    Düsseldorf, 40549, Germany

  • John Radcliffe Hospital

    Oxford, OX3 9DU, United Kingdom

  • Mid Atlantic Retina - Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Midwest Eye Institute Northside

    Indianapolis, Indiana, 46290, United States

  • Moorfields Eye Hospital - NHS Foundation Trust

    London, EC1V 2PD, United Kingdom

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040, United States

  • Oftalmika Spolka z ograniczona odpowiedzialnoscia

    Bydgoszcz, 85-631, Poland

  • Ophthalamic Consultants of Boston (OCB)

    Boston, Massachusetts, 02114, United States

  • Oregon Retina

    Eugene, Oregon, 97401, United States

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169, United States

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064, United States

  • Retina Associates of Michigan

    Grand Blanc, Michigan, 48439, United States

  • Retina Associates of Western New York

    Rochester, New York, 14620, United States

  • Retina Associates, LLC

    Shawnee Mission, Kansas, 66204, United States

  • Retina Center Northwest

    Silverdale, Washington, 98383, United States

  • Retina Clinic London

    London, W1G 7LB, United Kingdom

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384, United States

  • Retina Consultants of Houston-TMC

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Orange County

    Fullerton, California, 92835, United States

  • Retina Consultants of San Diego

    Poway, California, 92064, United States

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231, United States

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211, United States

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711, United States

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240, United States

  • Retinal Research Institute (retina consultants of AZ)

    Phoenix, Arizona, 85053, United States

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah, 84107, United States

  • Sierra Eye Associates

    Reno, Nevada, 89502, United States

  • Southeast Retina Center

    Augusta, Georgia, 30909, United States

  • Southeastern Retina Associates, PC

    Knoxville, Tennessee, 37922, United States

  • Southwest Retina Research Center

    Durango, Colorado, 81303, United States

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP, United Kingdom

  • Sydney Hospital and Sydney Eye Hospital

    Sydney, New South Wales, 2000, Australia

  • Texas Retina Associates (Dallas)

    Dallas, Texas, 75231, United States

  • The Retina Care Center

    Baltimore, Maryland, 21209, United States

  • The University of Melbourne - The Centre for Eye Research Australia (CERA)

    Melbourne E., Victoria, 3002, Australia

  • Universitaetsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, 23562, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076, Germany

  • University Retina Macula Associates PC

    Lemont, Illinois, 60452, United States

  • University of California (UC) Davis Medical Group Eye Center

    Sacramento, California, 95817, United States

  • Universitätsklinikum Bonn

    Bonn, 53127, Germany

  • VitreoRetinal Associates, P.A.

    Gainesville, Florida, 32607, United States

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266, United States

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