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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01297569
First received: February 15, 2011
Last updated: January 17, 2014
Last verified: January 2014
  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 4

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:


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 ]

Enrollment: 7
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab Drug: Ranibizumab

  Eligibility

Ages Eligible for Study:   18 Years to 18 Years
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
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: NCT01297569

Locations
Norway
Novartis Investigative Site
Oslo, Norway, 0264
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: January 17, 2014
Health Authority: United States: Food and Drug Administration
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 October 02, 2014