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

Phase 2

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Ranibizumab 0.3 mg; Drug: Sham injection; Drug: Ranibizumab 0.5 mg

• Registration Number: NCT00284050
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-01-30
• Study First Submitted QC: 2006-01-30
• Study First Posted: 2006-01-31
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2010-12-20
• Results First Submitted QC: 2010-12-21
• Results First Posted: 2011-01-20
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab 0.3 mg	Ranibizumab 0.3 mg	Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
Sham injection	Sham injection	Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
Ranibizumab 0.5 mg	Ranibizumab 0.5 mg	Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12	Baseline through the end of study (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.
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	Baseline through the end of study (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.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12	Baseline through the end of study (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.

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland