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Gene therapy shot for dry AMD shows promise in early trial

NCT ID NCT04437368

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a single injection of a gene therapy called GT005 in 98 people with geographic atrophy, an advanced form of dry age-related macular degeneration that causes vision loss. The goal was to see if the treatment could slow the growth of damaged areas in the eye and check for side effects. The trial was stopped early, so results are limited.

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

98 people

The number who actually took part.

Started

Apr 2019

Finished

Apr 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. 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) 4. Have GA lesion(s) total size between or equal to 1.25mm2 to 17.5mm2 in the study eye 5. The GA lesion(s) 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, defined as either: 1. Non-exudative/sub-clinical fellow eye CNV identified at Screening, or 2. Known history of fellow eye CNV with either ≥2 years since diagnosis or with no active treatment required in 6 months prior to Screening 7. Have a BCVA of 24 letters (6/95 and 20/320 Snellen acuity equivalent) or better, using ETDRS charts, in the study eye 8. Part 1 Only: Subjects carrying a CFI rare variant genotype (minor allele frequency of ≤1%) previously associated with low serum CFI or subjects carrying an unreported CFI rare variant genotype that have tested to have a low serum CFI 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. A pregnancy test is not required for postmenopausal women (defined as being at least 12 consecutive months without menses) or those surgically sterilised (those having a bilateral tubal ligation/bilateral salpingectomy, bilateral tubal occlusive procedure, hysterectomy, or bilateral oophorectomy) Exclusion Criteria: 1. Subjects who have a clinical diagnosis of Stargardt Disease or other retinal dystrophies, confirmed by the central reading centre 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 Screening (Visit 1). Yttrium aluminium garnet capsulotomy is permitted if performed \>10 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 in the study eye; uncontrolled IOP despite the use of two or more topical agents; a history of glaucoma-filtering or valve surgery is also excluded 8. Axial myopia of greater than -8 dioptres in the study eye 9. 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 10. Have a contraindication to specified protocol corticosteroid regimen 11. Have received any investigational and/or approved product(s) 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 in the study eye or systemically 12. Have received a gene or cell therapy at any time 13. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant 14. 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

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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

  • Austin Research Center for Retina, PLLC

    Austin, Texas, 78705, United States

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136, United States

  • Bristol Eye Hospital

    Bristol, BS1 2LX, United Kingdom

  • Byers Eye Institute at Stanford

    Palo Alto, California, 94303, United States

  • CHU Hôpital F. Mitterrand

    Dijon, Bourgogne-Franche-Comté, 21079, France

  • CHU de Nantes - Hôtel-Dieu

    Nantes, Pays de la Loire Region, 44000, France

  • Casey Eye Institute

    Portland, Oregon, 97239, United States

  • Centre Paradis Monticelli

    Marseille, Alpes-Cote d'Azur, 13008, France

  • Charles Retina Institute

    Memphis, 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 Oftalvist Valencia

    Valencia, 46100, Spain

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, Navarre, 31008, Spain

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Department of Ophthalmology UW Medicine

    Seattle, Washington, 98104-2499, United States

  • Erie Retinal Surgery, INC

    Erie, Pennsylvania, 16507, United States

  • Hospital La Arruzafa

    Córdoba, 14012, Spain

  • Hospital Universitari General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195, Spain

  • Internationale Innovative Ophthalmochirurgie

    Düsseldorf, 40549, Germany

  • Mid Atlantic Retina

    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

  • Oftalmika Spolka z ograniczona odpowiedzialnoscia

    Bydgoszcz, 85-631, Poland

  • Ophthalmic Consultants of Boston (OCB)

    Boston, Massachusetts, 02114, United States

  • Oregon Retina

    Eugene, Oregon, 97401, United States

  • Retina Associates of Southern California

    Huntington Beach, California, 92647, United States

  • Retina Associates of Western New York

    Rochester, New York, 14620, United States

  • Retina Consultants San Diego

    Poway, California, 92064, United States

  • Retina Consultants of Houston-TMC

    Bellaire, Texas, 77401, 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

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2SB, United Kingdom

  • 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

  • St. Franziskus-Hospital

    Münster, 48145, Germany

  • St.Paul's Eye Unit

    Liverpool, L7 8XP, United Kingdom

  • Stichting Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA, Netherlands

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP, United Kingdom

  • Sydney Hospital and Sydney Eye Hospital

    Sydney, 2000, Australia

  • Texas Retina Associates

    Dallas, Texas, 75231, United States

  • The Retina Care Center

    Baltimore, Maryland, 21209, United States

  • The Retina Clinic London

    London, W1G 7LB, United Kingdom

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

    Melbourne E., Victoria, Australia

  • Universitaetsklinikum Bonn

    Bonn, 53127, Germany

  • Universitaetsklinikum Schleswig-Holstein Campus Lübeck

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitatsklinikum Tübingen

    Tübingen, 72076, Germany

  • University Retina Macula Associates PC

    Lemont, Illinois, 60439, United States

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109, United States

  • VitreoRetinal Associates, P.A.

    Gainesville, Florida, 32607, United States

  • VitreoRetinal Surgery, PLLC

    Minneapolis, Minnesota, 55435, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.