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

NCT01315275 | Completed Phase 4

• 2 other identifiers: CRFB002DFR082010-023315-34
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 43

Brief 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.

Conditions

Visual Impairment; Macular Edema

Keywords

visual impairment; macular edema; ranibizumab; visual impairment due to macular edema

Outcome Measures

Primary Outcomes (1)

• proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)

  6 months

Secondary Outcomes (5)

• 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

Study Arms (1)

Ranibizumab

EXPERIMENTAL

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (43)

Novartis Investigative Site

Paris, France, F-75571, France

Location

Novartis Investigative Site

Amiens, 80054, France

Location

Novartis Investigative Site

Angers, 49044, France

Location

Novartis Investigative Site

Besançon, 25030, France

Location

Novartis Investigative Site

Bobigny, 93009, France

Location

Novartis Investigative Site

Bordeaux, 33000, France

Location

Novartis Investigative Site

Bordeaux, 33100, France

Location

Novartis Investigative Site

Caen, 14050, France

Location

Novartis Investigative Site

Cesson-Sévigné, 35510, France

Location

Novartis Investigative Site

Clermont-Ferrand, 63014, France

Location

Novartis Investigative Site

Créteil, 94000, France

Location

Novartis Investigative Site

Grenoble, 38000, France

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Lyon, 69007, France

Location

Novartis Investigative Site

Lyon, 69275, France

Location

Novartis Investigative Site

Lyon, 69317, France

Location

Novartis Investigative Site

Lyon, 69437, France

Location

Novartis Investigative Site

Mantes La Joile, 78201, France

Location

Novartis Investigative Site

Marseille, 13008, France

Location

Novartis Investigative Site

Marseille, 13385, France

Location

Novartis Investigative Site

Melun, 77000, France

Location

Novartis Investigative Site

Montpellier, 34000, France

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Nice, 06000, France

Location

Novartis Investigative Site

Nîmes, 30029, France

Location

Novartis Investigative Site

Osny, 95520, France

Location

Novartis Investigative Site

Paris, 75006, France

Location

Novartis Investigative Site

Paris, 75007, France

Location

Novartis Investigative Site

Paris, 75015, France

Location

Novartis Investigative Site

Paris, 75940, France

Location

Novartis Investigative Site

Puilboreau, 17138, France

Location

Novartis Investigative Site

Reims, 51092, France

Location

Novartis Investigative Site

Rouen, 76100, France

Location

Novartis Investigative Site

Saint-Brieuc, 22015, France

Location

Novartis Investigative Site

Saint-Etienne, 42000, France

Location

Novartis Investigative Site

Saint-Priest-en-Jarez, 42270, France

Location

Novartis Investigative Site

Saitnt Herblain, 44819, France

Location

Novartis Investigative Site

St.-Jean, 31240, France

Location

Novartis Investigative Site

Strasbourg, 67000, France

Location

Novartis Investigative Site

Toulouse, 31077, France

Location

Novartis Investigative Site

Tours, 37044, France

Location

Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511, France

Location

Novartis Investigative Site

Vannes, 56000, France

Location

Related Links

• Journal Article for CRFB002DFR08

MeSH Terms

Conditions

Vision Disorders; Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 15, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

FR (43)