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A Phase 2a Study to Evaluate Safety and Tolerability After Single Administration of PER-001 Intravitreal Implant in Participants With Diabetic Retinopathy
This is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study.
Details
| Lead sponsor | Perfuse Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 24 |
| Start date | 2023-08-05 |
| Completion | 2026-04 |
Conditions
- Diabetic Retinopathy
Interventions
- PER-001 Intravitreal Implant - Low Dose
- PER-001 Intravitreal Implant - High Dose
- PER-001 Intravitreal Implant - Sham
Primary outcomes
- Best-corrected Visual Acuity (BCVA) — End of Study(Week 24)
Change in BCVA from Baseline at Week 24 using BETDRS or modified ETDRS chart (Charts 1, 2, and R as applicable) with standardized distance and lighting ill be used to calculate the LogMAR score - Intraocular Pressure (IOP) — End of Study(Week 24)
IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry. - Ocular Adverse events — End of Study(Week 24)
Frequency, severity and timing of ocular adverse events reported during the study will have verbatim terms mapped to corresponding thesaurus terms from the Medical Dictionary for Regulatory Activities coding dictionary and reported in a table summary for each active and sham participants - Systemic Adverse events — End of Study(Week 24)
Frequency, severity and timing of systemic adverse events reported during the study will have verbatim terms mapped to corresponding thesaurus terms from the Medical Dictionary for Regulatory Activities coding dictionary and reported in a table summary for each active and sham participants
Countries
United States