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

NCT00284050 | Completed Phase 2 Results

• 1 other identifier: CRFB002D2201
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

DME; Diabetic macular edema; ranibizumab; Diabetic macular edema with center involvement

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (1)

• Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12

  Baseline through the end of study (Month 12)

Study Arms (3)

Ranibizumab 0.3 mg

EXPERIMENTAL

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

Ranibizumab 0.5 mg

EXPERIMENTAL

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

Sham injection

SHAM COMPARATOR

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

Interventions

Ranibizumab 0.3 mg DRUG

6 mg/ml ranibizumab solution for intravitreal injection

Ranibizumab 0.3 mg

Ranibizumab 0.5 mg DRUG

10 mg/ml ranibizumab solution for intravitreal injection

Ranibizumab 0.5 mg

Sham injection DRUG

Non-treatment control for sham intravitreal injection.

Sham injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

Basel, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 20980427 DERIVED

MeSH Terms

Interventions

Ranibizumab; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis

  Novartis Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2006
• First Posted: January 31, 2006
• Study Start: October 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 24, 2011
• Results First Posted: January 20, 2011

Record last verified: 2011-02

Locations

CH (1)