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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01297569
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Ranibizumab Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ranibizumab Drug: Ranibizumab


Outcome Measures
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Primary Outcome Measures :
  1. Change in Best Corrected Visual Acuity(BCVA) [ Time Frame: from month 0 (baseline) to month 12 ]

Secondary Outcome Measures :
  1. change in central retinal thickness (CRT) [ Time Frame: from month 0 to month 12 ]
  2. the number of injections needed [ Time Frame: 12 months ]
  3. the number of patients with improvement in BCVA from baseline [ Time Frame: 12 months ]
  4. the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84 [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 18 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297569


Locations
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Norway
Novartis Investigative Site
Oslo, Norway, 0264
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:
Results for CRFB002DNO02 from Novartis Clinical Trials website  This link exits the ClinicalTrials.gov site

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01297569    
Other Study ID Numbers: CRFB002DNO02
2010-021182-76 ( EudraCT Number )
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diabetic macular edema
Macular edema
DME
Diabetic retinopathy
 Diabetic eye disease
anti-VEGF
ranibizumab
Lucentis
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
 Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents