Phase 2
N=151
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT00284050 ↗Enrolled (actual)
151
Serious AEs
17.9%
Results posted
Jan 2011
Primary outcome: Primary: 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 — 9.2; 6.4; -0.1 Letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ranibizumab 0.3 mg (Drug); Ranibizumab 0.5 mg (Drug); Sham injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
9.2; 6.4; -0.1 | — |
| PRIMARY Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12 |
11.8; 8.8; -1.4 | — |
| SECONDARY Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12 |
-200.7; -187.6; -48.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00284050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.