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Completed

NCT Number: NCT01892163

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

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Moorfields Eye Hospital NHS Foundation trust

London, EC1V 2PD, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ozurdex

Device

Dexamethasone implant (Ozurdex)

Other names: Dexamethasone

Primary outcomes

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

    Time frame: Baseline and 12 months

Secondary outcomes

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

    Time frame: 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

  2. Difference Between Arms in Change in Central Subfield Thickness.

    Time frame: 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

  3. Proportion of Patients With Ocular and Systemic Serious Adverse Events

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Collaborators

  • Brighton and Sussex University Hospitals NHS Trust
  • Frimley Park Hospital NHS Trust
  • The Royal Wolverhampton Hospitals NHS Trust
  • University Hospitals Bristol and Weston NHS Foundation Trust

Registry information

Official study 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

Acronym: OZDRY

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 4, 2013
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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