Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema

Novartis Pharmaceuticals135 enrolled

Overview

The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

135

Conditions

Diabetic Retinopathy

Interventions

ranibizumab 0.5 mgDRUG

intravitreal injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0% * Patients with visual impairment due to DME in at least one eye * BCVA ≥ 24 and ≤ 78 letters in the study eye Exclusion Criteria: * Active intraocular inflammation * Any active infection in either eye at the * Structural damage within 0.5 disc diameter of the center of the macula in the study eye * Uncontrolled glaucoma in either eye at screening Other protocol-defined inclusion/exclusion criteria may apply.

Locations (30)

Novartis Investigative Site

Outcomes

Primary Outcomes

Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)

BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity

Time frame: Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12