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)

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

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.

Study Overview

• Status: Completed
• Conditions: Macular Edema; Visual Impairment
• Intervention / Treatment: Drug: Ranibizumab

• Study Type: Interventional
• Enrollment (Actual): 394
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • 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, 33000
    • Novartis Investigative Site
  • Bordeaux, France, 33100
    • 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, 69437
    • Novartis Investigative Site
  • Lyon, France, 69275
    • Novartis Investigative Site
  • Lyon, France, 69007
    • 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, 75015
    • Novartis Investigative Site
  • Paris, France, 75007
    • 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
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ranibizumab	Drug: Ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
mean average change in BCVA from baseline	6 months
if the letters gain after 2 injections is predictive from the letters gain at 6 months	6 months
mean number of injections needed to obtain a 10 letters gain	6 months
mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments	6 months
efficacy of ranibizumab IVT on Central Retinal Thickness (OCT)	6 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 11, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (Estimate): March 15, 2011

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: macular edema; visual impairment; ranibizumab; visual impairment due to macular edema
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Sensation Disorders; Macular Edema; Edema; Vision, Low; Vision Disorders; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: CRFB002DFR08; 2010-023315-34 (EudraCT Number)