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

Phase 4

Completed

• Conditions: Visual Impairment; Macular Edema
• Interventions: Drug: Ranibizumab

• Registration Number: NCT01315275
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Ranibizumab	-

Primary Outcome Measures

Name	Time	Method
proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)	6 months

Secondary Outcome Measures

Name	Time	Method
mean average change in BCVA from baseline	6 months
mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments	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
efficacy of ranibizumab IVT on Central Retinal Thickness (OCT)	6 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇫🇷 Vannes, France