Overview

Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration)

Status:
Completed
Trial end date:
2015-11-23
Target enrollment:
0
Participant gender:
All
Summary
The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Ranibizumab
Criteria
Key Inclusion criteria:

- Patients with visual impairment due to neovascular AMD

- A qualifying vision score at study entry Key Exclusion criteria

- Active infection or inflammation either eye at study entry

- Uncontrolled glaucoma in either eye

- Any disorder in the study eye which may affect vision

- Use of any systemic anti-vascular endothelial growth factor (VEGF)-drugs within 3
months prior to study entry

- Previous treatment of the study eye for wet AMD

- Any surgery in the study eye 3 months prior to or planned with 6 month after study
entry