Status:
COMPLETED
Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema
Lead Sponsor:
Oculis
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Anti-inflammatory or anti-angiogenic drugs play an ever- increasing role in the treatment of diabetic macular edema (DME). The drug delivery systems, such as injections of corticosteroid and or vascul...
Eligibility Criteria
Inclusion
- Key
- Had DME of less than 3 years duration since diagnosis with presence of intraretinal and/or subretinal fluid in the study eye, with CMT of ≥ 310 µm by SD-OCT at baseline (Visit 2) (as measured by the Investigator).
- Had definite retinal thickening in the study eye due to DME involving the central macula based on the Investigator's clinical evaluation and by SD-OCT;
- ...
- Key
Exclusion
- Had macular edema considered to be due to a cause other than DME;
- Had a decrease in BCVA due to causes other than DME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, non-retinal condition, substantial cataract, macular ischemia) that is likely to be decreasing BCVA by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
- ...
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2019
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT05343156
Start Date
September 18 2017
End Date
March 28 2019
Last Update
June 28 2022
Active Locations (1)
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1
Glostrup Hospital
Glostrup Municipality, Denmark, 2600