Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GT005 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| GT005 | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| 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. |
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.