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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
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
 Drug: Ranibizumab
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in Best Corrected Visual Acuity(BCVA) [ Time Frame: from month 0 (baseline) to month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab Drug: Ranibizumab

  Eligibility

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297569

Contacts
Contact: Kari Myren, MD kari.myren@novartis.com

Locations
Norway
Novartis Investigative site Recruiting
Bodo, Norway
Novartis Investigative Site Recruiting
Oslo, Norway
Novartis Investigative site Recruiting
Trondheim, Norway
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: NCT01297569     History of Changes
Other Study ID Numbers: CRFB002DNO02, 2010-021182-76
Study First Received: February 15, 2011
Last Updated: April 27, 2012
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Novartis:
Diabetic macular edema
Macular edema
DME
Diabetic retinopathy
 Diabetic eye disease
anti-VEGF
ranibizumab
Lucentis

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013