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

NCT01892163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-02-23

Study results available
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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.

Conditions

Interventions

DEVICE

Ozurdex

Dexamethasone implant (Ozurdex)

Sponsors & Collaborators

  • The Royal Wolverhampton Hospitals NHS Trust

    collaborator OTHER_GOV

  • Frimley Park Hospital NHS Trust

    collaborator OTHER

  • Brighton and Sussex University Hospitals NHS Trust

    collaborator OTHER

  • University Hospitals Bristol and Weston NHS Foundation Trust

    collaborator OTHER

  • Moorfields Eye Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Sobha Sivaprasad, FRCS · Moorfields Eye Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01892163 on ClinicalTrials.gov