CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled / 103 target
Drug / intervention
APX3330 +1 moredrug
Likely dose
120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04692688
NCT04692688Phase 2CompletedMonitor (1.6/mo)Completion was 41mo ago

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

Ocuphire Pharma, Inc.·interventional·Posted Jan 5, 2021·Updated Jun 8, 2026

In Brief

A Phase 2 clinical trial evaluating APX3330 and Placebo for Diabetic Retinopathy and 3 related conditions. Completed, enrolled 103 participants across 24 sites.

Signals

Enrolling slower than its timeline implies

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJan 5, 2021
Enrollment StartApr 8, 2021
Primary CompletionJan 25, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.5 years ago

Arms & Interventions

APX3330experimental

Five 120 mg tablets will be taken by mouth as follows: 3 tablets every morning and 2 tablets every evening.

Drug: APX3330
Placeboplacebo_comparator

Five 120 mg tablets will be taken by mouth as follows: 3 tablets every morning and 2 tablets every evening.

Drug: Placebo

Interventions

APX3330drug

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.

Placebodrug

Placebo tablets are identical to APX3330 tablets except for the absence of the active pharmaceutical ingredient.