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Ranibizumab "Treat and Extend" in Diabetic Macular Edma (OPTIMAL)

This study is currently recruiting participants.
Verified April 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01297569
First received: February 15, 2011
Last updated: April 27, 2012
Last verified: April 2012
History of Changes

February 15, 2011
April 27, 2012
August 2011
October 2012   (final data collection date for primary outcome measure)
Change in Best Corrected Visual Acuity(BCVA) [ Time Frame: from month 0 (baseline) to month 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01297569 on ClinicalTrials.gov Archive Site
  • change in central retinal thickness (CRT) [ Time Frame: from month 0 to month 12 ] [ Designated as safety issue: No ]
  • the number of injections needed [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • the number of patients with improvement in BCVA from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ranibizumab "Treat and Extend" in Diabetic Macular Edma
An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized "Treat and Extend" Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema

This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Macular Edema
Drug: Ranibizumab
Experimental: Ranibizumab
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.
 
Recruiting
30
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Visual impairment due to focal or diffuse macular edema with center involvement
  • Diabetes type 1 or 2, HbA1c < 12.0%
  • CRT = or > 250 μm

Exclusion Criteria:

  • Active inflammation or infection
  • Uncontrolled glaucoma
  • Iris neovascularization, active proliferative retinopathy or vitreomacular traction
  • Prior laser photocoagulation according to defined timelines
  • History of stroke, uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply
Both
18 Years and older
No
Contact: Kari Myren, MD kari.myren@novartis.com
Norway
 
NCT01297569
CRFB002DNO02, 2010-021182-76
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

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