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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01892163
Recruitment Status : Completed
First Posted : July 4, 2013
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Collaborators:
The Royal Wolverhampton Hospitals NHS Trust
Frimley Park Hospital NHS Trust
Brighton and Sussex University Hospitals NHS Trust
University Hospitals Bristol NHS Foundation Trust
Information provided by (Responsible Party):
Sobha Sivaprasad, 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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Device: Ozurdex Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Ozurdex PRN dosing
Ozurdex PRN dosing versus Ozurdex fixed dosing
Device: Ozurdex
Dexamethasone implant (Ozurdex)
Other Name: Dexamethasone

Experimental: Ozurdex fixed dosing Device: Ozurdex
Dexamethasone implant (Ozurdex)
Other Name: Dexamethasone




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892163


Locations
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United Kingdom
Moorfields Eye Hospital NHS Foundation trust
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
The Royal Wolverhampton Hospitals NHS Trust
Frimley Park Hospital NHS Trust
Brighton and Sussex University Hospitals NHS Trust
University Hospitals Bristol NHS Foundation Trust
Investigators
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Principal Investigator: Sobha Sivaprasad, FRCS Moorfields Eye Hospital NHS Foundation Trust

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Responsible Party: Sobha Sivaprasad, Consultant, Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01892163    
Other Study ID Numbers: SIVS1007
First Posted: July 4, 2013    Key Record Dates
Results First Posted: February 23, 2017
Last Update Posted: February 23, 2017
Last Verified: January 2017
Keywords provided by Sobha Sivaprasad, Moorfields Eye Hospital NHS Foundation Trust:
Diabetic macular edema, Ozurdex
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action