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

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

Ozurdex

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic macular edema, Ozurdex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Moorfields Eye Hospital NHS Foundation trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ozurdex PRN dosing

Ozurdex fixed dosing

Arm Description

Ozurdex PRN dosing versus Ozurdex fixed dosing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Proportion of Patients With Ocular and Systemic Serious Adverse Events

Full Information

NCT ID

NCT01892163

First Posted

June 25, 2013

Last Updated

January 3, 2017

Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Collaborators

The 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

1. Study Identification

Unique Protocol Identification Number

NCT01892163

Brief Title

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

Acronym

OZDRY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Collaborators

The 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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

Keywords

Diabetic macular edema, Ozurdex

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ozurdex PRN dosing

Arm Type

Active Comparator

Arm Description

Ozurdex PRN dosing versus Ozurdex fixed dosing

Arm Title

Ozurdex fixed dosing

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Ozurdex

Other Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone implant (Ozurdex)

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline and 12 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and 12 months

Title

Difference Between Arms in Change in Central Subfield Thickness.

Description

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

Title

Proportion of Patients With Ocular and Systemic Serious Adverse Events

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sobha Sivaprasad, FRCS

Organizational Affiliation

Moorfields Eye Hospital NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Moorfields Eye Hospital NHS Foundation trust

City

London

ZIP/Postal Code

EC1V 2PD

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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