CompletedPhase 2

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

Switzerland151 participantsStarted 2005-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Baseline through the end of study (Month 12)

Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12

Timeframe: Baseline through the end of study (Month 12)

Trial details

NCT IDNCT00284050

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-06

Results submitted2010-12-20

View on ClinicalTrials.gov More Diabetic Macular Edema trials