Clinical trial NCT05481827: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Age Related Macular Degeneration (AMD)
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
Lead sponsor: Gyroscope Therapeutics Limited
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2022-08-01
Enrollment: 225
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Incidence and severity of ocular and systemic adverse events (AEs)
timeFrame: up to Week 260
Secondary outcomes:
Other outcomes:
Locations:
city: Poway
country: United States
facility: Retina Consultants San Diego - Poway
state: California
city: Durango
country: United States
facility: Southwest Retina Research Center
state: Colorado
city: Gainesville
country: United States
facility: Vitreo Retinal Associates Pa - the Millennium Center Location
state: Florida
city: Pompano Beach
country: United States
facility: Rand Eye Institute, Inc. (Rei)
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Lemont
country: United States
facility: University Retina and Macula Associates, P.C. - Lemont Office
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute Northside
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Baltimore
country: United States
facility: The Retina Care Center, Llc - Baltimore Location
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston (OCB)
state: Massachusetts
city: Chesterfield
country: United States
facility: Pepose Vision Institute, P.C - Midwest Vision Research Foundation
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western New York
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Eugene
country: United States
facility: Sterling Vision - Oregon Retina, Llp
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina - Wills Eye Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Retina Consultants of Austin
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates (Tra) - Dallas Main
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio (Rcsa) - Medical Center
state: Texas
city: Melbourne E.
country: Australia
facility: The University of Melbourne - The Centre for Eye Research Australia (CERA)
state: Victoria
city: Dijon
country: France
facility: CHU Dijon - Hopital Mitterrand
city: Nantes
country: France
facility: CHU de Nantes - Hôtel-Dieu
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Barcelona
country: Spain
facility: Instituto de microcirugía ocular
city: Madrid
country: Spain
facility: Clinica Baviera
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona
city: London
country: United Kingdom
facility: The Retina Clinic London
city: Sunderland
country: United Kingdom
facility: South Tyneside and Sunderland Nhs Foundation Trust - Sunderland Eye Infirmary
Study officials:
References: