Safety and Efficacy of Ranibizumab in Diabetic Macular Edema

Phase 3TerminatedNCT01131585

Novartis Pharmaceuticals128 enrolled

Overview

This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

128

Conditions

Visual Impairment Due to Diabetic Macular Edema

Interventions

Active laser photocoagulationPROCEDURE

Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Sham injectionsDRUG

Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Ranibizumab 0.5 mgDRUG

Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Visual acuity impairment caused by macular edema in at least one eye * Type 1 or type 2 diabetes mellitus * Stable medication of diabetes in past 3 month Exclusion Criteria: * Patients with uncontrolled systemic or ocular diseases * Laser photocoagulation in the study eye for the last 3 months * Any history of any intraocular surgery in the study eye within the past 3 months * Blood pressure \> 160/100 mmHg Other protocol defined inclusion/exclusion criteria may apply

Locations (34)

Outcomes

Primary Outcomes

Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12

Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.

Time frame: 12 months

Data from ClinicalTrials.gov

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Novartis Investigative Site

Aschaffenburg, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Bonn, Germany

Novartis Investigative Site

Bremen, Germany

Novartis Investigative Site

Chemnitz, Germany

Novartis Investigative Site

Cologne, Germany

Novartis Investigative Site

Darmstadt, Germany

Novartis Investigative Site

Dessau, Germany

Novartis Investigative Site

Dortmund, Germany

Novartis Investigative Site

Dresden, Germany

...and 24 more locations