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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Ranibizumab 0.3 mg
Ranibizumab 0.5 mg
Sham injection
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring DME, Diabetic macular edema, ranibizumab, Diabetic macular edema with center involvement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Ranibizumab 0.3 mg

Ranibizumab 0.5 mg

Sham injection

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 30, 2006
Last Updated
February 22, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00284050
Brief Title
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
DME, Diabetic macular edema, ranibizumab, Diabetic macular edema with center involvement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab 0.3 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Ranibizumab 0.5 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham injection
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.3 mg
Intervention Description
6 mg/ml ranibizumab solution for intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.5 mg
Intervention Description
10 mg/ml ranibizumab solution for intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Sham injection
Intervention Description
Non-treatment control for sham intravitreal injection.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline through the end of study (Month 12)
Title
Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12
Description
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.
Time Frame
Baseline through the end of study (Month 12)
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12
Description
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.
Time Frame
Baseline through the end of study (Month 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
Basel
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20980427
Citation
Massin P, Bandello F, Garweg JG, Hansen LL, Harding SP, Larsen M, Mitchell P, Sharp D, Wolf-Schnurrbusch UE, Gekkieva M, Weichselberger A, Wolf S. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care. 2010 Nov;33(11):2399-405. doi: 10.2337/dc10-0493.
Results Reference
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Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement

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