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

M

Moorfields Eye Hospital NHS Foundation Trust

Status and phase

Completed
Phase 3

Conditions

Diabetic Macular Edema

Treatments

Device: Ozurdex

Study type

Interventional

Funder types

Other

Identifiers

NCT01892163
SIVS1007

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Ozurdex PRN dosing
Active Comparator group
Description:
Ozurdex PRN dosing versus Ozurdex fixed dosing
Treatment:
Device: Ozurdex
Ozurdex fixed dosing
Experimental group
Treatment:
Device: Ozurdex

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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