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Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy — ZETA-1  

Diabetic Retinopathy Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04692688
Study type Interventional
Source Ocuphire Pharma, Inc.
Contact
Status Completed
Phase Phase 2
Start date April 8, 2021
Completion date January 25, 2023
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