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

February 22, 2011 updated by: Novartis

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ranibizumab 0.3 mg
6 mg/ml ranibizumab solution for intravitreal injection
Experimental: 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.
Drug: Ranibizumab 0.5 mg
10 mg/ml ranibizumab solution for intravitreal injection
Sham Comparator: 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.
Drug: Sham injection
Non-treatment control for sham intravitreal injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
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)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12
Time Frame: 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.
Baseline through the end of study (Month 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 30, 2006

First Submitted That Met QC Criteria

January 30, 2006

First Posted (Estimate)

January 31, 2006

Study Record Updates

Last Update Posted (Estimate)

February 24, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002D2201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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