Ocuphire Pharma Results
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Key Eligibility Criteria in ZETA-1
Oral Medication Provides Binocular Treatment; DME Allowed in Fellow Eye
Inclusion
Males or non-pregnant females ≥ 18 years of age
At least one eye with DR graded at least moderately
severe to severe NPDR or mild PDR (corresponding
to DRSS 47, 53, or 61, confirmed by a central reading
center) in which PRP and intravitreal injections of an
anti-VEGF agent can be safely deferred for ≥ 6 months
in the opinion of the Investigator
BCVA assessed by ETDRS protocol letters score
of ≥ 60 letters (Snellen equivalent 20/63 or better)
in the study eye
Body mass index (BMI) between
18 and 40 kg/m², inclusive
Ocuphire Source: ZETA-1 trial
PHARMA
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Exclusion
Retinopathy from causes other than diabetes in study eye
Presence of center involved diabetic macular edema (DME)
defined as a central subfield thickness (CST) ≥ 320 μm on SD-OCT
or the presence of intra- or subretinal fluid within the central subfield
Center involved DME in the fellow eye is allowed
Prior treatment in study eye with focal/grid laser photocoagulation
within the past year, PRP at any time, systemic or intravitreal
anti-VEGF agents within last 6 months in study eye
Intraocular steroids including triamcinolone and dexamethasone
implant within the last 6 months
Fluocinolone implant within the last 3 years
HbA1c ≥ 12.0%
Clinically significant systemic disease (e.g., uncontrolled diabetes,
myasthenia gravis, cancer, hepatic, renal, endocrine, or cardio-
vascular disorders) that might interfere as deemed by Investigator
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