A Clinical Study in Current Medical Practice of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema
NCT ID: NCT01315275
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
394 participants
INTERVENTIONAL
2011-02-28
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ranibizumab
Ranibizumab
Interventions
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Ranibizumab
Eligibility Criteria
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Inclusion Criteria
* Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines) with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes.
* Patients with visual impairment due to focal or diffuse DME in at least one eye
* Central Retinal thickness on OCT ≥ 250 microns in the central subfield
* BCVA score between 78 and 39 letters, inclusively, using ETDRS-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160)
* Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
* Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.
Exclusion Criteria
* Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
* Active intraocular inflammation (grade trace or above) in either eye
* Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
* History of uveitis in either eye Systemic conditions or treatments
* Active systemic infection
* History of stroke \< 3 months
* Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels \> 2.0 mg/dl
* Untreated diabetes mellitus
* Blood pressure systolic \> 160 mmHg and diastolic \> 100 mmHg
* Untreated hypertension
* Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Others
* Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Paris, France, France
Novartis Investigative Site
Amiens, , France
Novartis Investigative Site
Angers, , France
Novartis Investigative Site
Besançon, , France
Novartis Investigative Site
Bobigny, , France
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Caen, , France
Novartis Investigative Site
Cesson-Sévigné, , France
Novartis Investigative Site
Clermont-Ferrand, , France
Novartis Investigative Site
Créteil, , France
Novartis Investigative Site
Grenoble, , France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Mantes La Joile, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Melun, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Nice, , France
Novartis Investigative Site
Nîmes, , France
Novartis Investigative Site
Osny, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Puilboreau, , France
Novartis Investigative Site
Reims, , France
Novartis Investigative Site
Rouen, , France
Novartis Investigative Site
Saint-Brieuc, , France
Novartis Investigative Site
Saint-Etienne, , France
Novartis Investigative Site
Saint-Priest-en-Jarez, , France
Novartis Investigative Site
Saitnt Herblain, , France
Novartis Investigative Site
St.-Jean, , France
Novartis Investigative Site
Strasbourg, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Tours, , France
Novartis Investigative Site
Vandœuvre-lès-Nancy, , France
Novartis Investigative Site
Vannes, , France
Countries
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Related Links
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Journal Article for CRFB002DFR08
Other Identifiers
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2010-023315-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRFB002DFR08
Identifier Type: -
Identifier Source: org_study_id
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