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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
225
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.
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.
Time frame: up to Week 260
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Retina Consultants San Diego - Poway
Poway, California, United States
Southwest Retina Research Center
Durango, Colorado, United States
Vitreo Retinal Associates Pa - the Millennium Center Location
Gainesville, Florida, United States
Rand Eye Institute, Inc. (Rei)
Pompano Beach, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
University Retina and Macula Associates, P.C. - Lemont Office
Lemont, Illinois, United States
Midwest Eye Institute Northside
Indianapolis, Indiana, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
The Retina Care Center, Llc - Baltimore Location
Baltimore, Maryland, United States
Ophthalmic Consultants of Boston (OCB)
Boston, Massachusetts, United States
...and 22 more locations