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RGX-314 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Commercial Formulation Dose 1 | EXPERIMENTAL | Dose 1 of RGX-314 |
| Clinical Formulation Dose 1 | EXPERIMENTAL | Dose 1 of RGX-314 |
| Commercial Formulation Dose 2 | EXPERIMENTAL | Dose 2 of RGX-314 |
| Clinical Formulation Dose 2 | EXPERIMENTAL | Dose 2 of RGX-314 |
| Main Observational Study | NO_INTERVENTION | All subjects that previously received RGX-314 in a subretinal administration parent study are enrolled into this arm. |
| RGX-314 Fellow Eye Treatment Substudy | EXPERIMENTAL | RGX-314 Fellow Eye Treatment |
| Name | Type | Description |
|---|---|---|
| RGX-314 | GENETIC | RGX-314 is a recombinant adeno-associated virus gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein |
Inclusion Criteria: 1. Males or females, aged ≥ 50 years and ≤ 89 years. 2. An Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA-letter score between ≤ 78 and ≥ 40 in the study eye at Screening. 3. Diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration i...
RGX-314 is an investigational gene therapy being developed for neovascular age-related macular degeneration (nAMD), also known as wet macular degeneration. It is designed to treat this condition, which causes abnormal blood vessel growth and leakage in the retina, leading to vision loss.
RGX-314 is a gene therapy intended to treat neovascular age-related macular degeneration. It works by delivering a gene that encodes for an anti-angiogenic protein, which inhibits the growth of abnormal blood vessels in the eye. This mechanism aims to reduce vascular leakage and preserve vision.
RGX-314 is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the therapy for neovascular age-related macular degeneration.
RGX-314 is currently in Phase 2 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The ongoing trials are evaluating its safety and efficacy for neovascular age-related macular degeneration.
RGX-314 has two Phase 2 clinical trials. NCT03999801 is a long-term follow-up study with 865 participants, currently enrolling by invitation. NCT04832724 is a completed pharmacodynamic study with 60 participants. Both trials are conducted in the United States for neovascular age-related macular degeneration.
RGX-314 is a gene therapy specifically developed for neovascular age-related macular degeneration (nAMD), commonly known as wet AMD. It is not the same as existing treatments but is designed to address the underlying cause of the condition by providing long-term expression of an anti-angiogenic protein.