Safety and Efficacy of Ranibizumab in Diabetic Macular Edema

Phase 3

Terminated

• Conditions: Visual Impairment Due to Diabetic Macular Edema
• Interventions: Procedure: Active laser photocoagulation; Drug: Ranibizumab 0.5 mg; Drug: Sham injections

• Registration Number: NCT01131585
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-27
• Study Start: 2010-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2012-07-12
• Results First Submitted QC: 2012-07-12
• Status Verified: 2012-08
• Results First Posted: 2012-08-17
• Last Update Submitted: 2012-08-20
• Last Update Posted: 2012-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active laser photocoagulation and ranibizumab	Active laser photocoagulation	Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Active laser photocoagulation and ranibizumab	Ranibizumab 0.5 mg	Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Active laser photocoagulation and sham injection	Sham injections	Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Active laser photocoagulation and sham injection	Active laser photocoagulation	Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Primary Outcome Measures

Name	Time	Method
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12	12 months	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Würzburg, Germany