Ranibizumab "Treat and Extend" in Diabetic Macular Edma

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Visual impairment due to focal or diffuse macular edema with center involvement

• Diabetes type 1 or 2, HbA1c < 12.0%

• CRT = or > 250 μm

Exclusion Criteria:

• Active inflammation or infection

• Uncontrolled glaucoma

• Iris neovascularization, active proliferative retinopathy or vitreomacular traction

• Prior laser photocoagulation according to defined timelines

• History of stroke, uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply