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

Phase 3

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Device: Ozurdex

• Registration Number: NCT01892163
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-04
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-09-13
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-03
• Last Update Submitted: 2017-01-03
• Results First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozurdex PRN dosing	Ozurdex	Ozurdex PRN dosing versus Ozurdex fixed dosing
Ozurdex fixed dosing	Ozurdex	-

Primary Outcome Measures

Name	Time	Method
The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients With Ocular and Systemic Serious Adverse Events	12 months
Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25).	Baseline and 12 months	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
Difference Between Arms in Change in Central Subfield Thickness.	Baseline and 12 months	Central subfield thickness is defined as the average thickness in the central 1mm diameter circle of the ETDRS grid and is measured in microns

Trial Locations

Locations (1)

Moorfields Eye Hospital NHS Foundation trust; 🇬🇧 London, United Kingdom