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Age Related Macular Degeneration (AMD)Phase 2ORACLENCT05481827

ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study

A Phase 2 study testing GT005 in people with Age Related Macular Degeneration (AMD), run by Gyroscope Therapeutics Limited at 32 sites in 6 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the long-term safety of GT005 in participants with Geographic Atrophy (GA) secondary to AMD who have been treated in an antecedent study. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Age Related Macular Degeneration (AMD)
What is being tested?
GT005
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
32 sitesin 6 countries
Study dates
12 Jul 2022to 2 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to give written informed consent
  • Received GT005 in an antecedent study, GT005-01 (FOCUS, NCT03846193), GT005-02 (EXPLORE, NCT04437368) and GT005-03 (HORIZON, NCT04566445)
  • Willing to attend study visits and complete the study procedures.

Who cannot join

None listed.

Trial locations and contacts

32 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

32 sites in 6 countries

United States22 sites

  • Retina Consultants of Austin

    Austin, Texas, 78705

  • The Retina Care Center, Llc - Baltimore Location

    Baltimore, Maryland, 21209

  • Ophthalmic Consultants of Boston (OCB)

    Boston, Massachusetts, 02114

  • Pepose Vision Institute, P.C - Midwest Vision Research Foundation

    Chesterfield, Missouri, 63017

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Texas Retina Associates (Tra) - Dallas Main

    Dallas, Texas, 75231

  • Southwest Retina Research Center

    Durango, Colorado, 81303

  • Sterling Vision - Oregon Retina, Llp

    Eugene, Oregon, 97401-2127

  • Vitreo Retinal Associates Pa - the Millennium Center Location

    Gainesville, Florida, 32607-2557

  • Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center

    Houston, Texas, 77030-2727

  • Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center

    Houston, Texas, 77030

  • Midwest Eye Institute Northside

    Indianapolis, Indiana, 46290

  • University Retina and Macula Associates, P.C. - Lemont Office

    Lemont, Illinois, 60439-7421

  • Columbia University Medical Center

    New York, New York, 10032

  • Mid Atlantic Retina - Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Rand Eye Institute, Inc. (Rei)

    Pompano Beach, Florida, 33064

  • Retina Consultants San Diego - Poway

    Poway, California, 92064

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • Retinal Consultants of San Antonio (Rcsa) - Medical Center

    San Antonio, Texas, 78240

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

Other trials in United States

Spain3 sites

  • Instituto de microcirugía ocular

    Barcelona, 08035

  • Clinica Baviera

    Madrid, 28046

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008

Other trials in Spain

France2 sites

  • CHU Dijon - Hopital Mitterrand

    Dijon, 21000

  • CHU de Nantes - Hôtel-Dieu

    Nantes, 44093

Other trials in France

Germany2 sites

  • Universitaetsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

United Kingdom2 sites

  • The Retina Clinic London

    London, W1G 7LB

  • South Tyneside and Sunderland Nhs Foundation Trust - Sunderland Eye Infirmary

    Sunderland, SR2 9HP

Other trials in United Kingdom

Australia1 site

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

    Melbourne E., Victoria, 3002

Other trials in Australia

About this study

The purpose of this study is to evaluate the long-term safety of GT005 in participants with Geographic Atrophy (GA) secondary to AMD who have been treated in an antecedent study.

Read the detailed description

This is a prospective, multi-centre, long-term, follow-up study for participants who have previously received GT005 in one of the antecedent clinical studies which were prematurely terminated GT005-01 (FOCUS), GT005-02 (EXPLORE) or GT005-03 (HORIZON). Participants from GT005-01 (FOCUS) study with only 1 last study visit to be conducted (Week 240) will remain in the study to complete their last visit. No investigational product will be administered within this study, and participants will be invited to enter ORACLE upon their completion or termination of the antecedent interventional study (whichever is soonest). This study will consist of up to three study visits prior to Week 96, and up to five study visits thereafter, for an overall period of 5-years post-GT005 administration.

Being tested
GT005
Keywords
Geographic Atrophy, Retinal disease, Retinal degeneration, Macular atrophy, Dry age-related macular degeneration, Macular degeneration, age-related macular degeneration (ARMD), retina damage, dry macular degeneration, AMD
Medical subject headings
Macular Degeneration, Geographic Atrophy, Retinal Diseases, Retinal Degeneration, Anetoderma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GT005Genetic

    GT005 is a gene therapy for GA and is a recombinant adeno-associated viral serotype 2 (AAV2) vector encoding for human complement factor I. GT005 was administered to all participants in an antecedent study prior to enrollment in ORACLE and GT005 is not administered in the ORACLE study.

Study groups in NCT05481827
Study groupRoleWhat they receive
GT005ExperimentalGT005 is a gene therapy for GA and is a recombinant adeno-associated viral serotype 2 (AAV2) vector encoding for human complement factor I. GT005 was administered to all participants in an antecedent study prior to enrollment in ORACLE and GT005 is not administered in the ORACLE study
Receives: Genetic: GT005

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of ocular and systemic adverse events (AEs)

    An AE is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the IMP.

    Measured: up to Week 260

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start12 Jul 2022
  3. Primary completion2 Jun 2028 (estimated)
  4. Study completion2 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
225 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05481827
Sponsor's protocol ID
GT-ORACLE
Other IDs
2020-003987-22, CPPY988A12203B
Acronym
ORACLE
Status last verified
Sep 2026
First submitted
28 Jul 2022
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GT005 in people with Age Related Macular Degeneration (AMD), run by Gyroscope Therapeutics Limited at 32 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Spain, France, Germany, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of ocular and systemic adverse events (AEs) (time frame: up to Week 260). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05481827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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