At a glance
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Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml, Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml, and 1 other intervention for Diabetic Macular Edema. Completed, enrolled 27 participants across 1 site.
Detailed Summary
Purpose: To determine the impact of short-term 4mg/ml dexamethasone solution treatment in diabetic macular edema (DME). Design: Phase II, randomized, prospective, parallel, interventional study. Participants: Pseudophakic patients with central-involved DME. Methods: Twenty-seven patients with visual impairment caused by DME were randomized in a 1:1:1 ratio, in order to investigate treatment with 0.01 ml, 0.03 ml and 0.05 ml intravitreous dexamethasone solutions, and followed-up over 28 days Outcome Measures: The primary outcome was macular thickness at three days after intravitreous dexamethasone. The secondary outcomes were macular thickness at 28 days after intravitreous dexamethasone, best-corrected visual acuity (BCVA) and intraocular pressure (IOP) at three and 28 days after intravitreous dexamethasone
Study Details
Timeline
Interventions
0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
0,05 ml intravitreous dexamethasone solution 4mg/ml injection.