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

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

July 12, 2022

Primary Completion Date

June 2, 2028

Study Completion Date

June 2, 2028

Conditions
Age Related Macular Degeneration (AMD)
Interventions
GENETIC

GT005

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.

Trial Locations (32)

3002

The University of Melbourne - The Centre for Eye Research Australia (CERA), Melbourne E.

10032

Columbia University Medical Center, New York

14620

Retina Associates of Western New York, Rochester

19107

Mid Atlantic Retina - Wills Eye Hospital, Philadelphia

21000

CHU Dijon - Hopital Mitterrand, Dijon

21209

The Retina Care Center, Llc - Baltimore Location, Baltimore

23538

Universitaetsklinikum Schleswig-Holstein, Lübeck

28046

Clinica Baviera, Madrid

31008

Clinica Universidad de Navarra - Pamplona, Pamplona

33064

Rand Eye Institute, Inc. (Rei), Pompano Beach

33711

Retina Vitreous Associates of Florida, St. Petersburg

44093

CHU de Nantes - Hôtel-Dieu, Nantes

45242

Cincinnati Eye Institute, Cincinnati

46290

Midwest Eye Institute Northside, Indianapolis

50266

Wolfe Eye Clinic, West Des Moines

63017

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

72076

Universitaetsklinikum Tuebingen, Tübingen

75231

Texas Retina Associates (Tra) - Dallas Main, Dallas

77030

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

78240

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

78705

Retina Consultants of Austin, Austin

81303

Southwest Retina Research Center, Durango

89502

Sierra Eye Associates, Reno

92064

Retina Consultants San Diego - Poway, Poway

32607-2557

Vitreo Retinal Associates Pa - the Millennium Center Location, Gainesville

60439-7421

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

02114

Ophthalmic Consultants of Boston (OCB), Boston

97401-2127

Sterling Vision - Oregon Retina, Llp, Eugene

77030-2727

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

08035

Instituto de microcirugía ocular, Barcelona

W1G 7LB

The Retina Clinic London, London

SR2 9HP

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

Sponsors
All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Gyroscope Therapeutics Limited

INDUSTRY