CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Ozurdexdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01892163
NCT01892163Phase 3Completed
CompareCT.gov

A Multicentre Prospective Open-label Randomised Clinical Trial Comparing the Efficacy of Fixed Versus PRN Dosing of 700 μg Dexamethasone Posterior Segment Drug Delivery System (Ozurdex) in Patients With Refractory Diabetic Macular Oedema

Moorfields Eye Hospital NHS Foundation Trust·interventional·Posted Jul 4, 2013·Updated Feb 23, 2017

In Brief

A Phase 3 clinical trial evaluating Ozurdex for Diabetic Macular Edema. Completed, enrolled 100 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesUnited Kingdom
CollaboratorsThe Royal Wolverhampton Hospitals NHS Trust, Frimley Park Hospital NHS Trust, Brighton and Sussex University Hospitals NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 4, 2013
Enrollment StartMar 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.0 years ago

Interventions

Ozurdexdevice

Dexamethasone implant (Ozurdex)