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Само по покана Фаза 2 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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Age Related Macular Degeneration (AMD)

Спонсор: Gyroscope Therapeutics Limited

Налично на: БГ
Обобщение
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.
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.
Кой може да участва
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.
Места на провеждане 6
Австралия (1)
The University of Melbourne - The Centre for Eye Research Australia (CERA)
Melbourne E. , Victoria
Франция (1)
CHU Dijon - Hopital Mitterrand
Dijon
Германия (1)
Universitaetsklinikum Schleswig-Holstein
Lübeck
Испания (1)
Instituto de microcirugía ocular
Barcelona
Великобритания (1)
The Retina Clinic London
London
САЩ (1)
Retina Consultants San Diego - Poway
Poway , California
Технически детайли
Статус
Само по покана
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
55 Years
Здрави доброволци
Не
Начална дата
12.07.2022
Крайна дата
02.06.2028
Регистрационен номер
NCT05481827
Източник
anzctr
Запитване за медицински туризъм

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