Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
QR-1123 · 1 trial · 8 indications
Incidence and severity of ocular adverse events scored based on CTCAC in the study and fellow eye
Incidence and severity of non-ocular adverse events scored based on CTCAC in the study and fellow eye
| Arm | Type | Description |
|---|---|---|
| QR-1123 Single dose - dose level 1 | EXPERIMENTAL | Open label Single dose cohort: dose level 1 |
| QR-1123 Single dose - dose level 2 | EXPERIMENTAL | Open label Single dose cohort: dose level |
| QR-1123 Single dose - dose level 3 | EXPERIMENTAL | Open label Single dose cohort: dose level 3 |
| QR-1123 Single dose - dose level 4 | EXPERIMENTAL | Open label Single dose cohort: dose level 4 |
| QR-1123 Single dose - dose level 5 | EXPERIMENTAL | Open label Single dose cohort: dose level 5 |
| Repeat dose cohort 1 | EXPERIMENTAL | Double-masked, randomized, sham controlled, Repeat dose cohort. Dose levels will be determined following DMC review of obtained safety and efficacy data. |
| Name | Type | Description |
|---|---|---|
| QR-1123 | DRUG | unilateral IVT injection |
| Sham procedure | OTHER | Sham procedures (i.e. no penetration of the globe) closely mimic the active injection and serve to mask subjects to treatment assignment |
Main Inclusion Criteria: 1. Male or female, ≥ 18 years of age. 2. Clinical presentation consistent with adRP, based on ophthalmic examinations. 3. Impairment on VF in the opinion of the Investigator, as determined by perimetry. 4. A molecular diagnosis of autosomal dominant form of RP with the P23H...