CompletedPhase 2

Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy

United States103 participantsStarted 2021-04-08

Plain-language summary

The objective of this study is to evaluate the safety and efficacy of APX3330 to treat diabetic retinopathy (DR) and diabetic macular edema (DME).

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)
✓. BCVA assessed by ETDRS protocol letters score of ≥ 60 letters (Snellen equivalent ≥ 20/63)
✓. Body mass index (BMI) between 18 and 40 kg/m2, inclusive

✕. Any prior treatment in the study eye with:
✕. Focal or grid laser photocoagulation within the past year or PRP at any time
✕. Systemic or intravitreal anti-VEGF agents within the last 6 months
✕. Intraocular steroids including triamcinolone and dexamethasone implant within the last 6 months
✕. Fluocinolone implant within the last 3 years
✕. Active uveitis, vitritis, or infection in either eye including infectious conjunctivitis, keratitis, scleritis, or endophthalmitis.
✕. Ocular incisional surgery including cataract surgery in the study eye within 3 months.
✕. Clinically significant ocular disease in either eye.

Percent of Subjects with an improvement in Diabetic Retinopathy Severity Score (DRSS)

Timeframe: 24 Weeks

NCT IDNCT04692688

SponsorOcuphire Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-25