Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy

Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy

Study Type :
Interventional  (Clinical Trial)

Estimated Enrollment :
66 participants

Allocation:
Randomized

Intervention Model:
Parallel Assignment

Intervention Model Description:
This study is a randomized, double-masked, placebo-controlled, multicenter study to investigate the efficacy and safety of OPL-0401 in patients with diabetes mellitus (DM) with non-proliferative diabetic retinopathy (NPDR) or mild PDR with or without diabetic macular edema (DME). Data from an interim analysis may be used to consider additional arms in the study.

Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:
This is a double-masked study in which participants, care providers, central reading center and investigators are masked to study intervention.

Primary Purpose:
Treatment

Official Title:
Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy

Actual Study Start Date :
August 16, 2022

Estimated Primary Completion Date :
July 2024

Estimated Study Completion Date :
August 2024

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

February 22, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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