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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ozurdex PRN dosing

Ozurdex PRN dosing versus Ozurdex fixed dosing

Group Type ACTIVE_COMPARATOR

Ozurdex

Intervention Type DEVICE

Dexamethasone implant (Ozurdex)

Ozurdex fixed dosing

Group Type EXPERIMENTAL

Ozurdex

Intervention Type DEVICE

Dexamethasone implant (Ozurdex)

Interventions

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Ozurdex

Dexamethasone implant (Ozurdex)

Intervention Type DEVICE

Other Intervention Names

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Dexamethasone

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No