NCT05822245

A Study of PER-001 in Participants With Open-Angle Glaucoma

A Phase 1/2a Study to Evaluate Safety, Tolerability, and Pharmacodynamic Effect After Single Administration of PER-001 Intravitreal Implant in Participants With Open-Angle Glaucoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Perfuse Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study has two phases: Phase 1 and Phase 2a. Phase 1 is an open-label, single ascending dose (SAD), while Phase 2a is a randomized, single-masked (participant) with a sham control.

Detailed description

This clinical study has two phases: Phase 1 and Phase 2a. Phase 1 is an open-label, SAD study to investigate the ocular and systemic safety and tolerability of two dose levels of PER-001, in participants with advanced OAG. Phase 1 will enroll up to approximately 12 participants. Phase 2a 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 progressing glaucoma. Participants who meet entry criteria will be randomized to receive either dose of PER-001 or sham control. In Phase 2a, a total of approximately 24 participants (12 in each Cohort, will be randomized).

Conditions

• Open-angle Glaucoma

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: 2023-05-25
• Primary completion: 2025-04-04
• Completion: 2026-04-04
• First posted: 2023-04-20
• Last updated: 2025-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study