Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Retinopathy, Diabetic Macular Edema, NPDR - Non Proliferative Diabetic Retinopathy, PDR - Proliferative Diabetic Retinopathy

In brief

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

Key facts

Study ID

NCT04692688

Run by

Ocuphire Pharma, Inc.

People needed

103

Starts

2021-04-08

Expected to finish

2023-01-25

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Clinical Site 9 — Phoenix, Arizona, United States
• Clinical Site 8 — Bakersfield, California, United States
• Clinical Site 5 — Beverly Hills, California, United States
• Clinical Site 11 — Palm Desert, California, United States
• Clinical Site 2 — Sacramento, California, United States
• Clinical Site 24 — Walnut Creek, California, United States
• Clinical Site 19 — Miami, Florida, United States
• Clinical Site 7 — Winter Haven, Florida, United States
• Clinical Site 6 — Carmel, Indiana, United States
• Clinical Site 14 — Hagerstown, Maryland, United States
• Clinical Site 22 — Springfield, Massachusetts, United States
• Clinical Site 17 — Grand Blanc, Michigan, United States
• Clinical Site 12 — Albuquerque, New Mexico, United States
• Clinical Site 15 — Shirley, New York, United States
• Clinical Site 20 — Charlotte, North Carolina, United States
• Clinical Site 1 — Rapid City, South Dakota, United States
• Clinical Site 18 — Austin, Texas, United States
• Clinical Site 16 — Bellaire, Texas, United States
• Clinical Site 10 — Fort Worth, Texas, United States
• Clinical Site 4 — McAllen, Texas, United States
• Clinical Site 3 — San Antonio, Texas, United States
• Clinical Site 23 — San Antonio, Texas, United States
• Clinical Site 13 — Southlake, Texas, United States
• Clinical Site 21 — Ogden, Utah, United States

Full record on ClinicalTrials.gov

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