A Phase 2/3 Double-Masked, Randomized, 2 Stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema
Dexamethasone ophthalmic suspension (OCS-01)
+ Vehicle
Treatment Study
Summary
Study start date: October 19, 2021
Actual date on which the first participant was enrolled.A Phase 2/3 Pivotal Double-masked, Randomized, Vehicle-controlled, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Participants with Diabetic Macular Edema Stage 1: To select a dose and dosing regimen for OCS-01 in participants with DME and evaluate the efficacy and safety of OCS-01 as compared to Vehicle in participants with DME. Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in participants with DME.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.552 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria (selection) - Stage 1: 1. Have a signed informed consent form before any study-specific procedures are performed. 2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). 3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus at Visit 1 (Screening). Inclusion Criteria (selection) - Stage 2: 1. Have a signed informed consent form before any study-specific procedures are performed. 2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). 3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus prior to Visit 1 (Screening). Exclusion criteria (selection) - Stage 1 and Stage 2: 1. Have macular edema considered to be because of a cause other than DME. 2. Have a decrease in BCVA because of causes other than DME. 3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 52 locations
Arizona Retina and Vitreous Consultants
Phoenix, United StatesOpen Arizona Retina and Vitreous Consultants in Google MapsPhoenix Retina Associates
Phoenix, United StatesRetina Partners of Northwest Arkansas
Springdale, United StatesRetina-Vitreous Associates Medical Group
Beverly Hills, United States