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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00284050
First received: January 30, 2006
Last updated: February 22, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Diabetic Macular Edema
Drug: Ranibizumab 0.3 mg
Drug: Ranibizumab 0.5 mg
Drug: Sham injection
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

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 [ Time Frame: Baseline through the end of study (Month 12) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline through the end of study (Month 12) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline through the end of study (Month 12) ] [ Designated as safety issue: No ]
    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.


Enrollment: 151
Study Start Date: October 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284050

Locations
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00284050     History of Changes
Other Study ID Numbers: CRFB002D2201
Study First Received: January 30, 2006
Results First Received: December 20, 2010
Last Updated: February 22, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
DME
Diabetic macular edema
ranibizumab
Diabetic macular edema with center involvement

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 01, 2014