Multicentre randomized controlled trial to evaluate whether 5 monthly fixed dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (Ozurdex) is as efficacious as Optical coherence tomography (OCT)-guided PRN dosing in patients with refractory diabetic macular edema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Dexamethasone implant (Ozurdex)
Moorfields Eye Hospital NHS Foundation trust
London, United Kingdom
The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months
Time frame: Baseline and 12 months
Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25).
NEI VFQ 25 is a questionnaire intended to measure visual function and quality of life. It has 25 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (lowest) to 100 (highest). Composite score = (Score for each item with a non-missing answer) / Total number of items with non-missing answers 100 = Best, 0 = Worst possible score
Time frame: Baseline and 12 months
Difference Between Arms in Change in Central Subfield Thickness.
Central subfield thickness is defined as the average thickness in the central 1mm diameter circle of the ETDRS grid and is measured in microns
Time frame: Baseline and 12 months
Proportion of Patients With Ocular and Systemic Serious Adverse Events
Time frame: 12 months
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