This is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
27
PER-001 Low Dose Intravitreal Implant
PER-001 High Dose Intravitreal Implant
PER-001 Intravitreal Sham
Perfuse Therapeutics, Inc
San Francisco, California, United States
Best-corrected Visual Acuity (BCVA)
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
Time frame: End of Study(Week 24)
Intraocular Pressure (IOP)
IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry.
Time frame: End of Study(Week 24)
Ocular Adverse events
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
Time frame: End of Study(Week 24)
Systemic Adverse events
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
Time frame: End of Study(Week 24)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.