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

Part of paid clinical trials in Poway, California.

Sponsor
Gyroscope Therapeutics Limited
Study ID
NCT05481827
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Age Related Macular Degeneration (AMD)

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GT005 — GENETIC
    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 Details

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.

Key Dates

Start date
Jul 12, 2022
Status verified
Mar 2024
Primary completion
Jun 2, 2028
Completion
Jun 2, 2028

Study Design

Enrollment
225 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: 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

Primary Outcome Measure

Incidence and severity of ocular and systemic adverse events (AEs) [ Time Frame: up to Week 260 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Retina Consultants San Diego - PowayPowayCalifornia92064-
Southwest Retina Research CenterDurangoColorado81303-
Vitreo Retinal Associates Pa - the Millennium Center LocationGainesvilleFlorida32607-2557-
Rand Eye Institute, Inc. (Rei)Pompano BeachFlorida33064-
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33711-
University Retina and Macula Associates, P.C. - Lemont OfficeLemontIllinois60439-7421-
Midwest Eye Institute NorthsideIndianapolisIndiana46290-
Wolfe Eye ClinicWest Des MoinesIowa50266-
The Retina Care Center, Llc - Baltimore LocationBaltimoreMaryland21209-
Ophthalmic Consultants of Boston (OCB)BostonMassachusetts02114-
Pepose Vision Institute, P.C - Midwest Vision Research FoundationChesterfieldMissouri63017-
Sierra Eye AssociatesRenoNevada89502-
Columbia University Medical CenterNew YorkNew York10032-
Retina Associates of Western New YorkRochesterNew York14620-
Cincinnati Eye InstituteCincinnatiOhio45242-
Sterling Vision - Oregon Retina, LlpEugeneOregon97401-2127-
Mid Atlantic Retina - Wills Eye HospitalPhiladelphiaPennsylvania19107-
Retina Consultants of AustinAustinTexas78705-
Texas Retina Associates (Tra) - Dallas MainDallasTexas75231-
Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical CenterHoustonTexas77030-2727-
Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical CenterHoustonTexas77030-
Retinal Consultants of San Antonio (Rcsa) - Medical CenterSan AntonioTexas78240-

Find similar trials in Poway, CA

By research site
Retina Consultants San Diego - Poway· Poway, CASouthwest Retina Research Center· Durango, COVitreo Retinal Associates Pa - the Millennium Center Location· Gainesville, FLRand Eye Institute, Inc. (Rei)· Pompano Beach, FLRetina Vitreous Associates of Florida· St. Petersburg, FLUniversity Retina and Macula Associates, P.C. - Lemont Office· Lemont, IL

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