Age Related Macular Degeneration (AMD)
Conditions
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
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.
Interventions
GENETICGT005
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.
Sponsors
Novartis Pharmaceuticals
Gyroscope Therapeutics Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of ocular and systemic adverse events (AEs) | up to Week 260 | 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. |
Countries
Australia, France, Germany, Spain, United Kingdom, United States
Outcome results
None listed