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

Diabetic Macular Edema Clinical Trial

— OZDRY  

Official title:

A Multicentre Prospective Open-label Randomised Clinical Trial Comparing the Efficacy of Fixed Versus PRN Dosing of 700 μg Dexamethasone Posterior Segment Drug Delivery System (Ozurdex) in Patients With Refractory Diabetic Macular Oedema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01892163
• Other study ID #: SIVS1007
• Status: Recruiting
• Phase: Phase 3
• First received: June 25, 2013
• Last updated: July 3, 2013
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: June 2013
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: Sobha Sivaprasad, FRCS
• Phone: 07817886759
• Email: sobha.sivaprasad[@]moorfields.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Device:
• Ozurdex
Dexamethasone implant (Ozurdex)

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital NHS Foundation trust	London

Sponsors (5)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust	Brighton and Sussex University Hospitals NHS Trust, Frimley Park Hospital NHS Trust, The Royal Wolverhampton Hospitals NHS Trust, University Hospitals Bristol NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between arms in the change from baseline in best corrected visual acuity at 12 months		12 months	No
Secondary	Difference between arms in change from baseline in each domain and composite scores of the National Eye Institute Visual function questionnaire (VFQ-25).		12 months	No
Secondary	Difference between arms in change in central subfield thickness.		12 months	No
Secondary	Proportion of patients with ocular and systemic serious adverse events		12 months	Yes