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rAAV2tYF-CB-hRS1 · 1 trial · 1 indication
Number of participants with ocular adverse events, assessed by standard ophthalmic examination, including slit lamp biomicroscopy, tonometry, and indirect ophthalmoscopy.
| Arm | Type | Description |
|---|---|---|
| Groups 1A and 1B | EXPERIMENTAL | Subjects at least 18 y/o treated with a lower dose of rAAV2tYF-CB-hRS1 study drug. |
| Groups 2 and 2A | EXPERIMENTAL | Subjects at least 6 y/o treated with a middle dose of rAAV2tYF-CB-hRS1 study drug. |
| Group 3 | EXPERIMENTAL | Subjects at least 18 y/o treated with a higher dose of rAAV2tYF-CB-hRS1 study drug. |
| Group 4 | EXPERIMENTAL | Subjects at least 6 y/o treated with a maximum tolerated dose of rAAV2tYF-CB-hRS1 study drug determined for Groups 1A, 1B, 2 and 3. |
| Name | Type | Description |
|---|---|---|
| rAAV2tYF-CB-hRS1 | BIOLOGICAL | adeno-associated virus vector expressing retinoschisin |
Inclusion Criteria include: 1. Retinal disease consistent with a diagnosis of XLRS and documented mutations in the RS1 gene 2. Male individual at least 18 years of age (dose escalation phase) or at least 6 years of age (maximum tolerated dose phase), 3. Able to perform tests of visual and retinal f...
rAAV2tYF-CB-hRS1 is an investigational gene therapy being developed for the treatment of X-linked Retinoschisis, a genetic eye disorder that causes vision loss. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
rAAV2tYF-CB-hRS1 is being developed by Elevance Health, Inc., a company traded on the stock exchange under the ticker symbol ELV. The drug is currently in Phase 1 clinical trials for X-linked Retinoschisis.
rAAV2tYF-CB-hRS1 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of X-linked Retinoschisis.
rAAV2tYF-CB-hRS1 has been studied in one clinical trial with the identifier NCT02416622. This Phase 1 trial, titled 'Safety and Efficacy of rAAV-hRS1 in Patients With X-linked Retinoschisis (XLRS)', has been completed and enrolled 27 male participants in the United States.
Yes, rAAV2tYF-CB-hRS1 is also known as rAAV-hRS1. The clinical trial NCT02416622 uses the name rAAV-hRS1 to refer to the same investigational gene therapy being developed for X-linked Retinoschisis.