Phase 2 Completed N=151 Randomized Double-blind Treatment

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

Diabetic Macular Edema

Source: ClinicalTrials.gov NCT00284050 ↗

Enrolled (actual)

151

Serious AEs

17.9%

Results posted

Jan 2011

Primary outcomePrimary: 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

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.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.