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

Macular Edema Clinical Trial

— LUDIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315275
• Other study ID #: CRFB002DFR08
• Secondary ID: 2010-023315-34
• Status: Completed
• Phase: Phase 4
• First received: March 11, 2011
• Last updated: February 20, 2017
• Start date: February 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Vision Disorders
• Visual Impairment

Intervention

Drug:
• Ranibizumab

Locations

Country	Name	City	State
France	Novartis Investigative Site	Amiens
France	Novartis Investigative Site	Angers
France	Novartis Investigative Site	Besançon cedex
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 Sevigne
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 Cedex 04
France	Novartis Investigative Site	Mantes la joile
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Marseille cedex 05
France	Novartis Investigative Site	Melun
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Nimes
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 Cedex 19
France	Novartis Investigative Site	Paris, Cedex 12
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	Saitnt Herblain
France	Novartis Investigative Site	St Jean
France	Novartis Investigative Site	St-Priest-en-Jarez
France	Novartis Investigative Site	Strasbourg
France	Novartis Investigative Site	Toulouse
France	Novartis Investigative Site	Tours
France	Novartis Investigative Site	Vandoeuvre les Nancy
France	Novartis Investigative Site	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)		6 months
Secondary	mean average change in BCVA from baseline		6 months
Secondary	if the letters gain after 2 injections is predictive from the letters gain at 6 months		6 months
Secondary	mean number of injections needed to obtain a 10 letters gain		6 months
Secondary	mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments		6 months
Secondary	efficacy of ranibizumab IVT on Central Retinal Thickness (OCT)		6 months

External Links

•   Journal Article for CRFB002DFR08
•   Results for CRFB002DFR08 from the Novartis Clinical Trials Website