Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03374657 | A First-in-human, Proof of Concept Study of CPK850 in Patients With RLBP1 Retinitis Pigmentosa | PHASE1 | ACTIVE NOT_RECRUITING | 12 | — | — | Aug 22, 2018 | May 11, 2026 | Jan 15, 2026 | 1 | Sweden |
Safety events
A patient is considered a responder if sensitivity recovery values at 1 hour post-bleach are observed to be outside of the patient's prediction interval at ≥2 consecutive post-treatment visits within one year after treatment.
| Arm | Type | Description |
|---|---|---|
| CPK Dose 1 (lowest dose) | EXPERIMENTAL | CPK850, one subretinal injection to the study eye |
| CPK Dose 2 (next lowest dose) | EXPERIMENTAL | CPK850, one subretinal injection to the study eye |
| CPK Dose 3 (third lowest dose) | EXPERIMENTAL | CPK850, one subretinal injection to the study eye |
| CPK Dose 4 (highest dose) | EXPERIMENTAL | CPK850, one subretinal injection to the study eye |
| Name | Type | Description |
|---|---|---|
| CPK850 | BIOLOGICAL | In one of 4 dose levels administered via subretinal injection under anesthesia |
Inclusion Criteria: * Male and female patients aged 18 to 70 years inclusive. * The visual acuity in the study eye at the screening 1 visit should be no better than 60 ETDRS letters. * Clinical diagnosis of Bothnia dystrophy, Newfoundland rod-cone dystrophy or other progressive retinitis pigmentosa...