Multicentre Randomised Clinical Trial Comparing Fixed vs Pro re Nata (PRN) Dosing of 700 μg Dexamethasone

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Device: Ozurdex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of either sex aged 18 years or over Diagnosis of diabetes mellitus (type 1 or type 2). Best corrected visual acuity in the study eye between ≥34 and ≤73 ETDRS letters at 1m at baseline attributable to diabetic macular edema (DME) On clinical exam at baseline in the study eye, retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield > 300 microns despite previous therapy. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs. Ability to return for study visits Visual acuity in fellow eye ≥ 2/60 Ability to give informed consent throughout the duration of the study Main Exclusion Criteria: Macular ischaemia Macular oedema is considered to be due to a cause other than diabetic macular oedema. Co-existent ocular disease An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study. A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ozurdex PRN dosing<br>Ozurdex PRN dosing versus Ozurdex fixed dosing | Device: Ozurdex<br>* Dexamethasone implant (Ozurdex)<br>* Other names: Dexamethasone;|
| Experimental: Ozurdex fixed dosing<br> | Device: Ozurdex<br>* Dexamethasone implant (Ozurdex)<br>* Other names: Dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months |  | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline and 12 months | 
| Proportion of Patients With Ocular and Systemic Serious Adverse Events |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic macular edema, Ozurdex