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

Diabetic Macular Edema research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Subjects of either sex aged 18 years or over 2. Diagnosis of diabetes mellitus (type 1 or type 2). 3. Best corrected visual acuity in the study eye between ≥34 and ≤73 ETDRS letters at 1m at baseline attributable to diabetic macular edema (DME) 4. 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. 5. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs. 6. Ability to return for study visits 7. Visual acuity in fellow eye ≥ 2/60 8. Ability to give informed consent throughout the duration of the study Main Exclusion Criteria: 1. Macular ischaemia 2. Macular oedema is considered to be due to a cause other than diabetic macular oedema. 3. Co-existent ocular disease 4. 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. 5. A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Diabetic Macular Edema

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:OzurdexDexamethasone implant (Ozurdex)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ozurdex PRN dosingOzurdex PRN dosing versus Ozurdex fixed dosing

Ozurdex fixed dosing

Study Status

Completed

Start Date: March 2013

Completed Date: December 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months

Secondary Outcome: Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25).

Study sponsors, principal investigator, and references

Principal Investigator: Sobha Sivaprasad, FRCS

Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Collaborator: The Royal Wolverhampton Hospitals NHS Trust

More information:https://clinicaltrials.gov/show/NCT01892163

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