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 (LUDIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01315275
First received: March 11, 2011
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to evaluate the proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) at 6 months in current medical practice.


Condition Intervention Phase
Visual Impairment
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, Multicenter, Phase IV Study of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema in Current Medical Practice

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean average change in BCVA from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • if the letters gain after 2 injections is predictive from the letters gain at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • mean number of injections needed to obtain a 10 letters gain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • efficacy of ranibizumab IVT on Central Retinal Thickness (OCT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 394
Study Start Date: February 2011
Study Completion Date: August 2012
Primary Completion Date: August 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:

  • Male or female patients >18 years of age who have signed an informed consent
  • 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:

Ocular concomitant conditions/ diseases

  • 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

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: NCT01315275

Locations
France
Novartis Investigative Site
Amiens, France, 80054
Novartis Investigative Site
Angers, France, 49044
Novartis Investigative Site
Besançon cedex, France, 25030
Novartis Investigative Site
Bobigny, France, 93009
Novartis Investigative Site
Bordeaux, France, 33100
Novartis Investigative Site
Bordeaux, France, 33000
Novartis Investigative Site
Caen, France, 14050
Novartis Investigative Site
Cesson Sevigne, France, 35510
Novartis Investigative Site
Clermont-ferrand, France, 63014
Novartis Investigative Site
Créteil, France, 94000
Novartis Investigative Site
Grenoble, France, 38000
Novartis Investigative Site
Lille, France, 59037
Novartis Investigative Site
Lyon, France, 69275
Novartis Investigative Site
Lyon, France, 69007
Novartis Investigative Site
Lyon, France, 69437
Novartis Investigative Site
Lyon Cedex 04, France, 69317
Novartis Investigative Site
Mantes la joile, France, 78201
Novartis Investigative Site
Marseille, France, 13008
Novartis Investigative Site
Marseille cedex 05, France, 13385
Novartis Investigative Site
Melun, France, 77000
Novartis Investigative Site
Montpellier, France, 34000
Novartis Investigative Site
Montpellier, France, 34295
Novartis Investigative Site
Nice, France, 06000
Novartis Investigative Site
Nimes, France, 30029
Novartis Investigative Site
Osny, France, 95520
Novartis Investigative Site
Paris, France, 75006
Novartis Investigative Site
Paris, France, 75007
Novartis Investigative Site
Paris, France, 75015
Novartis Investigative Site
Paris Cedex 19, France, 75940
Novartis Investigative Site
Paris, Cedex 12, France, F-75571
Novartis Investigative Site
Puilboreau, France, 17138
Novartis Investigative Site
Reims, France, 51092
Novartis Investigative Site
Rouen, France, 76100
Novartis Investigative Site
Saint Brieuc, France, 22015
Novartis Investigative Site
Saint Etienne, France, 42000
Novartis Investigative Site
Saitnt Herblain, France, 44819
Novartis Investigative Site
St Jean, France, 31240
Novartis Investigative Site
St-Priest-en-Jarez, France, 42270
Novartis Investigative Site
Strasbourg, France, 67000
Novartis Investigative Site
Toulouse, France, 31077
Novartis Investigative Site
Tours, France, 37044
Novartis Investigative Site
Vandoeuvre les Nancy, France, 54511
Novartis Investigative Site
Vannes, France, 56000
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: NCT01315275     History of Changes
Other Study ID Numbers: CRFB002DFR08, 2010-023315-34
Study First Received: March 11, 2011
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:
visual impairment
macular edema
ranibizumab
visual impairment due to macular edema

Additional relevant MeSH terms:
Edema
Macular Edema
Vision Disorders
Eye Diseases
Macular Degeneration
Nervous System Diseases
Neurologic Manifestations
Retinal Degeneration
Retinal Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014