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

Обзор

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.

Подробное описание

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.

Вмешательства

• Генная терапия 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.

Первичные конечные точки

• Incidence and severity of ocular and systemic adverse events (AEs) [Срок оценки: up to Week 260]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 22 центра

• Retina Consultants San Diego - Poway — Poway
• Southwest Retina Research Center — Durango
• Vitreo Retinal Associates Pa - the Millennium Center Location — Gainesville
• Rand Eye Institute, Inc. (Rei) — Pompano Beach
• Retina Vitreous Associates of Florida — St. Petersburg
• University Retina and Macula Associates, P.C. - Lemont Office — Lemont
• Midwest Eye Institute Northside — Indianapolis
• Wolfe Eye Clinic — West Des Moines
• … и ещё 14 центров

Испания · 3 центра

• Instituto de microcirugía ocular — Barcelona
• Clinica Baviera — Madrid
• Clinica Universidad de Navarra - Pamplona — Pamplona

Франция · 2 центра

• CHU Dijon - Hopital Mitterrand — Dijon
• CHU de Nantes - Hôtel-Dieu — Nantes

Германия · 2 центра

• Universitaetsklinikum Schleswig-Holstein — Lübeck
• Universitaetsklinikum Tuebingen — Tübingen

Великобритания · 2 центра

• The Retina Clinic London — London
• South Tyneside and Sunderland Nhs Foundation Trust - Sunderland Eye Infirmary — Sunderland

Австралия · 1 центр

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

Идентификаторы

NCT: NCT05481827 · GT-ORACLE · 2020-003987-22 · CPPY988A12203B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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