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ZETA-1: Diabetic Retinopathy Phase 2 Clinical Trial for APX3330

About the Trial

ZETA-1: Diabetic Retinopathy Phase 2 Clinical Trial for APX3330 (NCT04692688)

Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Orally Administered APX3330 in Subjects with Non-Proliferative Diabetic Retinopathy and Mild Proliferative Diabetic Retinopathy

Detailed Info

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

Study Phase

Phase 2

Estimated Enrollment

103

Estimated Primary Completion Date

January 25, 2023

Study Type

Interventional

Interventions
  • Drug: APX3330
  • Drug: Placebo
Sponsor

Ocuphire Pharma, Inc.

Eligibility

Inclusion Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

Ophthalmic:

  • 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.
  • Presence of macular or retinal vascular disease including diabetic macular edema, retinopathy from causes other than diabetes, age-related macular degeneration, pattern dystrophy, choroidal neovascularization of any cause, retinal vein occlusion, retinal artery occlusion in the study eye.
  • History of retinal detachment, full-thickness macular hole in the study eye, or idiopathic or autoimmune uveitis in either eye.

Systemic:

  • Known hypersensitivity or contraindication to study drug.
  • Any disease or medical condition that in the opinion of the Investigator would interfere with the study, prevent the subject from successfully participating in the study, or which might confound the study results.
  • Participation in any investigational study within 30 days prior to screening or planning to participate in any other investigational drug or device clinical trials within 30 days of study completion.
  • Resting HR outside the specified range (50-110 beats per minute).
  • Known to be immunocompromised or receiving immunosuppressive therapy.
  • Hypertension with resting diastolic blood pressure (BP) > 105 mmHg or systolic BP > 200 mmHg.
  • History of chronic liver disease or presence of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) consistent with such diagnosis.
  • Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

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