ORACLE: En langsigtet opfølgningsundersøgelse for at evaluere sikkerheden og holdbarheden af GT005 i et gyroskop-sponsoreret forudgående studie (ORACLE)
ORACLE: En langsigtet opfølgningsundersøgelse for at evaluere sikkerheden og holdbarheden af GT005 hos deltagere med geografisk atrofi, sekundær til aldersrelateret makuladegeneration, behandlet i et gyroskop-sponsoreret forudgående studie
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Victoria
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Melbourne E., Victoria, Australien, 3002
- The University of Melbourne - The Centre for Eye Research Australia (CERA)
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London, Det Forenede Kongerige, W1G 7LB
- The Retina Clinic London
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Sunderland, Det Forenede Kongerige, SR2 9HP
- South Tyneside and Sunderland Nhs Foundation Trust - Sunderland Eye Infirmary
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California
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Poway, California, Forenede Stater, 92064
- Retina Consultants San Diego - Poway
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Colorado
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Durango, Colorado, Forenede Stater, 81303
- Southwest Retina Research Center
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Florida
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Gainesville, Florida, Forenede Stater, 32607-2557
- Vitreo Retinal Associates Pa - the Millennium Center Location
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Pompano Beach, Florida, Forenede Stater, 33064
- Rand Eye Institute, Inc. (Rei)
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St. Petersburg, Florida, Forenede Stater, 33711
- Retina Vitreous Associates of Florida
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Illinois
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Lemont, Illinois, Forenede Stater, 60439-7421
- University Retina and Macula Associates, P.C. - Lemont Office
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46290
- Midwest Eye Institute Northside
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Iowa
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West Des Moines, Iowa, Forenede Stater, 50266
- Wolfe Eye Clinic
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Maryland
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Baltimore, Maryland, Forenede Stater, 21209
- The Retina Care Center, Llc - Baltimore Location
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Ophthalmic Consultants of Boston (OCB)
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Missouri
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Chesterfield, Missouri, Forenede Stater, 63017
- Pepose Vision Institute, P.C - Midwest Vision Research Foundation
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Nevada
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Reno, Nevada, Forenede Stater, 89502
- Sierra Eye Associates
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New York
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New York, New York, Forenede Stater, 10032
- Columbia University Medical Center
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Rochester, New York, Forenede Stater, 14620
- Retina Associates of Western New York
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45242
- Cincinnati Eye Institute
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Oregon
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Eugene, Oregon, Forenede Stater, 97401-2127
- Sterling Vision - Oregon Retina, Llp
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Mid Atlantic Retina - Wills Eye Hospital
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Texas
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Austin, Texas, Forenede Stater, 78705
- Retina Consultants of Austin
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Dallas, Texas, Forenede Stater, 75231
- Texas Retina Associates (Tra) - Dallas Main
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Houston, Texas, Forenede Stater, 77030-2727
- Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
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Houston, Texas, Forenede Stater, 77030
- Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
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San Antonio, Texas, Forenede Stater, 78240
- Retinal Consultants of San Antonio (Rcsa) - Medical Center
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Dijon, Frankrig, 21000
- CHU Dijon - Hopital Mitterrand
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Nantes, Frankrig, 44093
- CHU de Nantes - Hôtel-Dieu
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Barcelona, Spanien, 08035
- Instituto de microcirugía ocular
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Madrid, Spanien, 28046
- Clinica Baviera
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Pamplona, Spanien, 31008
- Clinica Universidad de Navarra - Pamplona
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Lübeck, Tyskland, 23538
- Universitaetsklinikum Schleswig-Holstein
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Tübingen, Tyskland, 72076
- Universitaetsklinikum Tuebingen
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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 |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence and severity of ocular and systemic adverse events (AEs)
Tidsramme: up to Week 260
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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. |
up to Week 260
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GT-ORACLE
- 2020-003987-22 (EudraCT nummer)
- CPPY988A12203B (Anden identifikator: Novartis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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