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 29, 2014
Last verified: September 2014

December 8, 2010
September 29, 2014
January 2011
April 2013   (final data collection date for primary outcome measure)
The change in mean Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01257815 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetic Retinopathy
  • Macular Oedema
Drug: Ranibizumab
Experimental: Ranibizumab 0.5mg
Intervention: Drug: Ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
April 2013
April 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01257815
CRFB002DGB14, 2010-022616-39
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP