Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration

• Status: Completed
• Trial end date: 2015-07-09
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections.

The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Visual impairment predominantly due to neovascular age-related macular degeneration AMD

• Active, newly diagnosed, untreated CNV due to AMD

• CNV involving the center of the retina

• A qualifying vision score at study entry

Exclusion Criteria:

• Stroke or myocardial infarction less than 3 Months prior to study entry

• Active injection or inflammation of either eye at the time of study entry