Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment
RELIGHT
2 other identifiers
interventional
111
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2011
Typical duration for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2010
CompletedFirst Posted
Study publicly available on registry
December 10, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedSeptember 30, 2014
September 1, 2014
2.2 years
December 8, 2010
September 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in mean Best Corrected Visual Acuity (BCVA)
Baseline to 12 months
Secondary Outcomes (5)
The change in mean Best Corrected Visual Acuity (BCVA)
Baseline to 18 months
Occurrence of ocular and systemic adverse events
Baseline to 18 months
Time course of changes in BCVA
From 6 to 12 and 18 months
Time course of changes in central retinal thickness
From baseline and 6 months to 12 and 18 months
Proportion of patients with 10 and 15 letter improvement or loss in BCVA
From baseline to 12 and 18 months
Study Arms (1)
Ranibizumab 0.5mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Novartis Investigative Site
Torquay, Devon,, TQ2 7AA, United Kingdom
Novartis Investigative Site
Hull, Hull, HU3 2JZ, United Kingdom
Novartis Investigative Site
Ayr, KA6 6DX, United Kingdom
Novartis Investigative Site
Belfast, BT12 6BA, United Kingdom
Novartis Investigative Site
Birmingham, B9 5SS, United Kingdom
Novartis Investigative Site
Cardiff, CF14 4XW, United Kingdom
Novartis Investigative Site
Colchester, CO3 3NB, United Kingdom
Novartis Investigative Site
Fife, KY12 OSU, United Kingdom
Novartis Investigative Site
Great Yarmouth, NR31 6LA, United Kingdom
Novartis Investigative Site
Liverpool, L7 8XP, United Kingdom
Novartis Investigative Site
London, E11 1NR, United Kingdom
Novartis Investigative Site
London, SE5 9RS, United Kingdom
Novartis Investigative Site
Rugby, CV22 5PX, United Kingdom
Novartis Investigative Site
Uxbridge, UB8 3NN, United Kingdom
Novartis Investigative Site
York, YO31 8HE, United Kingdom
Related Publications (1)
Pearce I, Banerjee S, Burton BJ, Chakravarthy U, Downey L, Gale RP, Gibson J, Pagliarini S, Patel J, Sivaprasad S, Andrews C, Brittain C, Warburton J; RELIGHT Study Group. Ranibizumab 0.5 mg for Diabetic Macular Edema with Bimonthly Monitoring after a Phase of Initial Treatment: 18-Month, Multicenter, Phase IIIB RELIGHT Study. Ophthalmology. 2015 Sep;122(9):1811-9. doi: 10.1016/j.ophtha.2015.05.038. Epub 2015 Jul 3.
PMID: 26150052DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2010
First Posted
December 10, 2010
Study Start
January 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
September 30, 2014
Record last verified: 2014-09