NCT04692688

Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Ocuphire Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

The objective of this study is to evaluate the efficacy of APX3330 to improve Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Score (DRSS) in one hundred (100) subjects with moderately severe to severe NPDR or mild PDR. Subjects with moderately severe to severe NPDR and mild PDR will be selected for study participation and be screened for study eligibility. The eligible eye with the highest DRSS, as assessed by the central reading center, will be designated as the study eye for the primary efficacy analysis. If the subject meets all eligibility criteria, then the subject will be randomized into the study and receive study medication. Blood will be drawn for biomarker analysis. The total length of subject participation is approximately 26 weeks, with 5 clinic visits, 4 telephone safety calls, and one telephone call follow-up visit. The execution of the entire study (first subject screen through last randomized subject completed) is expected to be approximately 12 to 15 months.

Conditions

• Diabetic Retinopathy
• Diabetic Macular Edema
• NPDR - Non Proliferative Diabetic Retinopathy
• PDR - Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	APX3330	APX3330, a small-molecule oral tablet, is a Ref-1 inhibitor that can potentially reduce proinflammatory and hypoxic signaling that contributes to several eye diseases.
DRUG	Placebo	Placebo tablets are identical to APX3330 tablets except for the absence of the active pharmaceutical ingredient.

Timeline

• Start date: 2021-04-08
• Primary completion: 2023-01-25
• Completion: 2023-01-25
• First posted: 2021-01-05
• Last updated: 2023-02-27

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study