To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Endothelial Growth Factors; Ranibizumab

Criteria

Inclusion Criteria:

• Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));

• BCVA must be between ≥ 24 and ≤ 83 letters;

• Visual loss should be mainly due to the presence of any eligible types of ME.

Exclusion Criteria:

• Women of child-bearing potential,

• Active malignancies;

• History of stroke less than 6 months prior to screening;

• Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;

• Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;

• Any type of advanced, severe or unstable ocular disease or its reatment;

• ME with a high likelihood of spontaneous resolution.

Other protocol-defined inclusion/exclusion criteria may apply.