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.
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 7 | PHASE3 | Surabgene Lomparvovec, RGX-314, ABBV-6628 |
| Ocular Therapeutix Inc | OCUL | 3 | PHASE3 | OTX-TKI |
| 4D Molecular Therapeutics, Inc. | FDMT | 3 | PHASE3 | 4D-150 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Aflibercept, Pozelimab, Cemdisiran |
| Novartis AG Sponsored ADR | NVS | 5 | PHASE2 | Iptacopan, GT005, FWY003 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Hoffmann-La Roche | RHHBY | 10 | PHASE3 | Ranibizumab, Susvimo, RO7965032, OpRegen, Faricimab |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Adverum Biotechnologies, Inc. | ADVM | 4 | PHASE3 | Ixo-vec, ADVM-022 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-3007 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 938, Aflibercept |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Ocugen Inc | OCGN | 1 | PHASE3 | OCU410 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-033 |
| Bayer | BAYRY | 2 | - | Aflibercept |
GT005 is an investigational gene therapy being developed for geographic atrophy secondary to age-related macular degeneration (AMD). It is intended for patients with AMD, a condition that can lead to progressive vision loss. GT005 is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
GT005 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of GT005 in patients with geographic atrophy secondary to age-related macular degeneration.
GT005 is currently in Phase 2 clinical development. It is an investigational gene therapy for geographic atrophy secondary to age-related macular degeneration. The drug has not been approved by the FDA or other regulatory agencies and remains under clinical investigation to assess its safety and potential benefits.
GT005 is being evaluated in a Phase 2 clinical trial identified as NCT05481827, titled ORACLE. This long-term follow-up study assesses the safety of GT005 in participants with geographic atrophy secondary to age-related macular degeneration who were treated in a prior Gyroscope-sponsored study. The trial is enrolling by invitation and aims to enroll 225 participants.
GT005 is a distinct investigational gene therapy developed by Novartis AG for geographic atrophy secondary to age-related macular degeneration. No alternative names for GT005 have been disclosed in the available clinical trial information. It is being studied under the clinical trial identifier NCT05481827.