Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase

• Status: Terminated
• Trial end date: 2015-04-29
• Target enrollment: 0
• Participant gender: All

Summary

The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Type I or type II diabetes with HbA1c≤10%

• Visual impairment due to a diabetic macular edema

• Stable antidiabetic treatment (since more than 3 months) or hygiene-dietary

Exclusion Criteria:

• Inflammation or infection in one eye

• Women of childbearing potential without an efficient contraception, pregnant or breastfeeding

Other protocol-defined inclusion/exclusion criteria may apply