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

NCT01892163 | Completed Phase 3 Results DMC

• 1 other identifier: SIVS1007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edema, Ozurdex

Outcome Measures

Primary Outcomes (1)

• The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months

  Baseline and 12 months

Secondary Outcomes (3)

• Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25).

  Baseline and 12 months

• Difference Between Arms in Change in Central Subfield Thickness.

  Baseline and 12 months

• Proportion of Patients With Ocular and Systemic Serious Adverse Events

  12 months

Study Arms (2)

Ozurdex PRN dosing

ACTIVE COMPARATOR

Ozurdex PRN dosing versus Ozurdex fixed dosing

Device: Ozurdex

Ozurdex fixed dosing

EXPERIMENTAL

Device: Ozurdex

Interventions

Ozurdex DEVICE

Dexamethasone implant (Ozurdex)

Also known as: Dexamethasone

Ozurdex PRN dosing; Ozurdex fixed dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead
• The Royal Wolverhampton Hospitals NHS Trust: collaborator
• Frimley Park Hospital NHS Trust: collaborator
• Brighton and Sussex University Hospitals NHS Trust: collaborator
• University Hospitals Bristol and Weston NHS Foundation Trust: collaborator

Study Sites (1)

Moorfields Eye Hospital NHS Foundation trust

London, EC1V 2PD, United Kingdom

Location

Results Point of Contact

• Title: Professor Sobha Sivaprasad
• Organization: Moorfields Eye Hospital NHS Foundation Trust

sobha.sivaprasad@moorfields.nhs.uk

02072533411

Study Officials

• Sobha Sivaprasad, FRCS

  Moorfields Eye Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 4, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-01

Locations

GB (1)