Phase 3 Completed N=100 Randomized Single-blind Treatment

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

Diabetic Macular Edema

Source: ClinicalTrials.gov NCT01892163 ↗

Enrolled (actual)

100

Serious AEs

19.0%

Results posted

Feb 2017

Primary outcomePrimary: The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months — 0; 0.53 ETDRS letters

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months	0; 0.53	—
SECONDARY Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25).	-0.45; 3.02	—
SECONDARY Difference Between Arms in Change in Central Subfield Thickness.	-90.1; -179.9	—
SECONDARY Proportion of Patients With Ocular and Systemic Serious Adverse Events	10; 9	—

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01892163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.