Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement

Novartis151 enrolled

Overview

This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

151

Conditions

Diabetic Macular Edema

Interventions

Ranibizumab 0.3 mgDRUG

6 mg/ml ranibizumab solution for intravitreal injection

Ranibizumab 0.5 mgDRUG

10 mg/ml ranibizumab solution for intravitreal injection

Sham injectionDRUG

Non-treatment control for sham intravitreal injection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetic macular edema with center involvement in at least one eye * Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening * Laser photocoagulation in the study eye can be withheld for at least 3 months after randomization Exclusion Criteria: * Patients with uncontrolled systemic or ocular diseases * Have any history of any intraocular surgery in the study eye within the past 6 months preceding screening * Conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids Other protocol-defined inclusion/exclusion criteria applied to the study.

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12

Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.

Time frame: Baseline through the end of study (Month 12)

Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12

Time frame: Baseline through the end of study (Month 12)

Secondary Outcomes

Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12

Optical Coherence Tomography (OCT) was assessed on both eyes at every study visit. These assessments were performed by trained personnel at the sites. OCT imaging was performed using the Zeiss Humphrey System Model 2000 (or later) with version A6.1 software running under Windows 95 or Windows 98. The analysis of the OCT images were performed by the Photographic Reading Center which provided a study manual and training materials. OCT operators, systems and software were certified prior to any evaluation of study patients.

Time frame: Baseline through the end of study (Month 12)

Data from ClinicalTrials.gov

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