Status:
COMPLETED
Multicentre Randomised Clinical Trial Comparing Fixed vs Pro re Nata (PRN) Dosing of 700 μg Dexamethasone
Lead Sponsor:
Moorfields Eye Hospital NHS Foundation Trust
Collaborating Sponsors:
The Royal Wolverhampton Hospitals NHS Trust
Frimley Park Hospital NHS Trust
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 tomog...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01892163
Start Date
March 1 2013
End Date
December 1 2014
Last Update
February 23 2017
Active Locations (1)
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1
Moorfields Eye Hospital NHS Foundation trust
London, United Kingdom, EC1V 2PD