Clinical trial NCT01315275: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Visual Impairment
Macular Edema
Keywords: visual impairment
macular edema
ranibizumab
visual impairment due to macular edema
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-03-15
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)
timeFrame: 6 months
Secondary outcomes:
measure: mean average change in BCVA from baseline
timeFrame: 6 months
measure: if the letters gain after 2 injections is predictive from the letters gain at 6 months
timeFrame: 6 months
measure: mean number of injections needed to obtain a 10 letters gain
timeFrame: 6 months
measure: mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments
timeFrame: 6 months
measure: efficacy of ranibizumab IVT on Central Retinal Thickness (OCT)
timeFrame: 6 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Novartis Investigative Site
city: Angers
country: France
facility: Novartis Investigative Site
city: Besançon cedex
country: France
facility: Novartis Investigative Site
city: Bobigny
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Bordeaux
country: France
facility: Novartis Investigative Site
city: Caen
country: France
facility: Novartis Investigative Site
city: Cesson Sevigne
country: France
facility: Novartis Investigative Site
city: Clermont-ferrand
country: France
facility: Novartis Investigative Site
city: Créteil
country: France
facility: Novartis Investigative Site
city: Grenoble
country: France
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Lyon Cedex 04
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Mantes la joile
country: France
facility: Novartis Investigative Site
city: Marseille cedex 05
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Melun
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Nimes
country: France
facility: Novartis Investigative Site
city: Osny
country: France
facility: Novartis Investigative Site
city: Paris Cedex 19
country: France
facility: Novartis Investigative Site
city: Paris, Cedex 12
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Puilboreau
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Saint Brieuc
country: France
facility: Novartis Investigative Site
city: Saint Etienne
country: France
facility: Novartis Investigative Site
city: Saitnt Herblain
country: France
facility: Novartis Investigative Site
city: St Jean
country: France
facility: Novartis Investigative Site
city: St-Priest-en-Jarez
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Tours
country: France
facility: Novartis Investigative Site
city: Vandoeuvre les Nancy
country: France
facility: Novartis Investigative Site
city: Vannes
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: