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

Diabetic Retinopathy Clinical Trial

— RELIGHT  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257815
• Other study ID #: CRFB002DGB14
• Secondary ID: 2010-022616-39
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2010
• Last updated: September 29, 2014
• Start date: January 2011
• Est. completion date: April 2013

Study information

• Verified date: September 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Edema
• Macular Edema
• Macular Oedema
• Retinal Diseases

Intervention

Drug:
• Ranibizumab

Locations

Country	Name	City	State
United Kingdom	Novartis Investigative Site	Ayr
United Kingdom	Novartis Investigative Site	Belfast
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Cardiff,
United Kingdom	Novartis Investigative Site	Colchester
United Kingdom	Novartis Investigative Site	Fife
United Kingdom	Novartis Investigative Site	Great Yarmouth
United Kingdom	Novartis Investigative Site	Hull
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Rugby
United Kingdom	Novartis Investigative Site	Torquay	Devon,
United Kingdom	Novartis Investigative Site	Uxbridge
United Kingdom	Novartis Investigative Site	York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in mean Best Corrected Visual Acuity (BCVA)		Baseline to 12 months	No
Secondary	The change in mean Best Corrected Visual Acuity (BCVA)		Baseline to 18 months	No
Secondary	Occurrence of ocular and systemic adverse events		Baseline to 18 months	Yes
Secondary	Time course of changes in BCVA		From 6 to 12 and 18 months	No
Secondary	Time course of changes in central retinal thickness		From baseline and 6 months to 12 and 18 months	No
Secondary	Proportion of patients with 10 and 15 letter improvement or loss in BCVA		From baseline to 12 and 18 months	No