Diabetic Macular Edema Clinical Trial
Official title:
A Pivotal, Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema
Verified date | January 2023 |
Source | Oculis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of OCS-01 ophthalmic suspension versus vehicle alone in subjects with DME
Status | Active, not recruiting |
Enrollment | 497 |
Est. completion date | August 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria (selection) : 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 and a glycosylated hemoglobin A1c (HbA1c) of = 12.0% (=108 mmol/mol) at Visit 1 (Screening). Exclusion criteria (selection): 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 (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, nonretinal condition, substantial cataract, macular ischemia). 2) Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye. |
Country | Name | City | State |
---|---|---|---|
United States | Oculis Investigative Site | Beverly Hills | California |
Lead Sponsor | Collaborator |
---|---|
Oculis | Syneos Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in BCVA (Best Corrected Visual Acuity) ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the EDTRS chart representing better visual acuity | Stage 1:
Mean change in BCVA ETDRS letters score at Visit 5 (Week 6) compared with baseline. Stage 2: Mean change in BCVA ETDRS letters score at Visit 9 (Week 52) compared with baseline. |
Week 52 | |
Secondary | Safety measures | • Incidence in Treatment Emergent Adverse Events assessed by site | at each visit throughout the study up to week 52 |
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