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

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:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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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