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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01257815
First received: December 8, 2010
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Diabetic Retinopathy
Macular Oedema
Drug: Ranibizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The change in mean Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in mean Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: No ]
  • Occurrence of ocular and systemic adverse events [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: Yes ]
  • Time course of changes in BCVA [ Time Frame: From 6 to 12 and 18 months ] [ Designated as safety issue: No ]
  • Time course of changes in central retinal thickness [ Time Frame: From baseline and 6 months to 12 and 18 months ] [ Designated as safety issue: No ]
  • Proportion of patients with 10 and 15 letter improvement or loss in BCVA [ Time Frame: From baseline to 12 and 18 months ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: January 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab 0.5mg Drug: Ranibizumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257815

Locations
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, 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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01257815     History of Changes
Other Study ID Numbers: CRFB002DGB14, 2010-022616-39
Study First Received: December 8, 2010
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Diabetes mellitus
Diabetic retinopathy
Macular oedema
Visual acuity

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration

ClinicalTrials.gov processed this record on August 26, 2014