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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01257815
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : September 30, 2014
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Macular Oedema Drug: Ranibizumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : January 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Ranibizumab 0.5mg Drug: Ranibizumab

Primary Outcome Measures :
  1. The change in mean Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline to 12 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01257815

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United Kingdom
Novartis Investigative Site
Torquay, Devon,, United Kingdom, TQ2 7AA
Novartis Investigative Site
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, E11 1NR
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Novartis Investigative Site
Rugby, United Kingdom, CV22 5PX
Novartis Investigative Site
Uxbridge, United Kingdom, UB8 3NN
Novartis Investigative Site
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01257815    
Other Study ID Numbers: CRFB002DGB14
2010-022616-39 ( EudraCT Number )
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diabetes mellitus
Diabetic retinopathy
Macular oedema
Visual acuity
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents