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
Overview
- Phase
- Phase 2
- Intervention
- Ranibizumab 0.3 mg
- Conditions
- Diabetic Macular Edema
- Sponsor
- Novartis
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
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.
Arms & Interventions
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.
Intervention: Ranibizumab 0.3 mg
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.
Intervention: Ranibizumab 0.5 mg
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.
Intervention: Sham injection
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12(Baseline through the end of study (Month 12))