NCT06003751

A Study of PER-001 in Participants With Diabetic Retinopathy

A Phase 2a Study to Evaluate Safety and Tolerability After Single Administration of PER-001 Intravitreal Implant in Participants With Diabetic Retinopathy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Perfuse Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study.

Detailed description

This clinical study is a randomized, single-masked (participant) study to further investigate the ocular and systemic safety and tolerability of the two dose levels of PER-001 Intravitreal Implants in participants with diabetic retinopathy. Participants who meet entry criteria will be randomized to receive either dose of PER-001 or sham control. A total of approximately 24 participants (12 in each Cohort, will be randomized).

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	PER-001 Intravitreal Implant - Low Dose	PER-001 Low Dose Intravitreal Implant
DRUG	PER-001 Intravitreal Implant - High Dose	PER-001 High Dose Intravitreal Implant
DRUG	PER-001 Intravitreal Implant - Sham	PER-001 Intravitreal Sham

Timeline

• Start date: 2023-08-05
• Primary completion: 2025-04-03
• Completion: 2026-04-01
• First posted: 2023-08-22
• Last updated: 2025-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study