Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment (RELIGHT)

September 29, 2014 updated by: Novartis Pharmaceuticals

Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment. A UK, 18-month, Prospective, Open-label, Multicentre, Single-arm, Phase IIIb Study With 12-month Primary Endpoint, Assessing the Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Diabetic Macular Oedema.

This study evaluates a new investigational treatment regimen of three consecutive monthly doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for the first three months then two-monthly follow-up until 18 months in patients with visual impairment due to diabetic macular oedema.The aim of the study is to determine if this treatment regimen is effective and safe in these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Ayr, United Kingdom, KA6 6DX
        • Novartis Investigative Site
      • Belfast, United Kingdom, BT12 6BA
        • Novartis Investigative Site
      • Birmingham, United Kingdom, B9 5SS
        • Novartis Investigative Site
      • Cardiff,, United Kingdom, CF14 4XW
        • Novartis Investigative Site
      • Colchester, United Kingdom, CO3 3NB
        • Novartis Investigative Site
      • Fife, United Kingdom, KY12 OSU
        • Novartis Investigative Site
      • Great Yarmouth, United Kingdom, NR31 6LA
        • Novartis Investigative Site
      • Hull, United Kingdom, HU3 2JZ
        • Novartis Investigative Site
      • Liverpool, United Kingdom, L7 8XP
        • Novartis Investigative Site
      • London, United Kingdom, SE5 9RS
        • Novartis Investigative Site
      • London, United Kingdom, E11 1NR
        • Novartis Investigative Site
      • Rugby, United Kingdom, CV22 5PX
        • Novartis Investigative Site
      • Uxbridge, United Kingdom, UB8 3NN
        • Novartis Investigative Site
      • York, United Kingdom, YO31 8HE
        • Novartis Investigative Site
    • Devon,
      • Torquay, Devon,, United Kingdom, TQ2 7AA
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Type 1 or Type 2 diabetes mellitus.
  • Patients with visual impairment due to focal or diffuse diabetic macular oedema (DMO), and not other causes, in at least one eye who are eligible for laser treatment in the opinion of the investigator.
  • Best Corrected Visual Acuity between 78 and 24 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS)-like grading charts (approximate Snellen equivalent of 20/32 to 20/320).
  • Increased central retinal thickness which, in the opinion of the investigator, is due to DMO.

Exclusion Criteria:

  • Concomitant conditions in the study eye that could prevent the improvement of visual acuity on study treatment.
  • Active intraocular inflammation (grade trace or above) or infection in either eye at enrollment.
  • History of uveitis in either eye at any time.
  • Structural damage within 0.5 disc diameters of the centre of the macular in the study eye likely to preclude improvement in visual acuity following resolution of macular oedema.
  • Planned medical or surgical intervention during the 18-month study period.
  • Uncontrolled glaucoma in either eye at screening.
  • Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg at screening.
  • Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids.
  • History of acute thromboembolic event within 4 months of screening.
  • Untreated diabetes mellitus.
  • Evidence of advanced, severe or unstable concomitant disease or its treatment which may interfere with evaluations or put the patient at special risk.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ranibizumab 0.5mg
Drug: Ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in mean Best Corrected Visual Acuity (BCVA)
Time Frame: Baseline to 12 months
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in mean Best Corrected Visual Acuity (BCVA)
Time Frame: Baseline to 18 months
Baseline to 18 months
Occurrence of ocular and systemic adverse events
Time Frame: Baseline to 18 months
Baseline to 18 months
Time course of changes in BCVA
Time Frame: From 6 to 12 and 18 months
From 6 to 12 and 18 months
Time course of changes in central retinal thickness
Time Frame: From baseline and 6 months to 12 and 18 months
From baseline and 6 months to 12 and 18 months
Proportion of patients with 10 and 15 letter improvement or loss in BCVA
Time Frame: From baseline to 12 and 18 months
From baseline to 12 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

December 8, 2010

First Submitted That Met QC Criteria

December 9, 2010

First Posted (Estimate)

December 10, 2010

Study Record Updates

Last Update Posted (Estimate)

September 30, 2014

Last Update Submitted That Met QC Criteria

September 29, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002DGB14
  • 2010-022616-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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