A Study of PER-001 in Participants With Open-Angle Glaucoma
brief 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).
official title
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