Ocuphire Pharma Results
ZETA-1 Phase 2b Design for DR/DME
Ongoing, Randomized, Double-Masked, Placebo-Controlled 24-Week Trial (Similar To Eylea P3 DR Trial)
25 US sites
90-100 participants with
moderately severe to
severe NPDR or mild
PDR
Noncentral DME
is permitted
Eligibility Screening
Ocuphire
1:1
PHARMA
Randomization
Week 0
APX3330 600 mg/day (BID)
Primary
Endpoint
Week 4
Week 12
Enrollment of 103 DR Patients Completed (Apr 2021 to Mar 2022)
Top Line Data Expected in Q4 2022
Placebo BID
NPDR = non-proliferative diabetic retinopathy (which includes non centrally involved diabetic macular edema)
PDR = proliferative diabetic retinopathy (which includes non centrally involved diabetic macular edema)
ZETA-1 Clinical Trial is Sponsored by Ocuphire Pharma https://clinicaltrials.gov/ct2/show/NCT04692688?term=ZETA-1&draw=2&rank=1
Week 24
Endpoints
Primary: % of subjects with a ≥2
step improvement on the DRSS
(Diabetic Retinopathy Severity
Scale) score at week 24
Secondary:
Central subfield thickness
(CST)
BCDVA (ETDRS)
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DRSS change at week 12
Rescue subjects
Safety and tolerability
Exploratory:
Labs / PK
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