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

Diabetic Macular Edema Clinical Trial

— RESOLVE  

Official title:

A Randomized, Double-masked, Multi-center, Phase II Study Assessing the Safety and Efficacy of Two Concentrations of Ranibizumab (Intravitreal Injections) Compared With Non-treatment Control for the Treatment of Diabetic Macular Edema With Center Involvement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284050
• Other study ID #: CRFB002D2201
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2006
• Last updated: February 22, 2011
• Start date: October 2005
• Est. completion date: June 2008

Study information

• Verified date: February 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Ranibizumab 0.3 mg
6 mg/ml ranibizumab solution for intravitreal injection
• Ranibizumab 0.5 mg
10 mg/ml ranibizumab solution for intravitreal injection
• Sham injection
Non-treatment control for sham intravitreal injection.

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through the end of study (Month 12)	No
Primary	Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at 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.	Baseline through the end of study (Month 12)	No
Secondary	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.	Baseline through the end of study (Month 12)	No