A Phase IV, Long-term, Open-label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

Novartis3 sites in 3 countries234 target enrollmentJuly 2007

ConditionsSubfoveal Choroidal Neovascularization (CNV)Secondary to Age-related Macular Degeneration (AMD)

Interventionsranibizumab

Drugsranibizumab

Overview

Phase: Phase 4
Intervention: ranibizumab
Conditions: Subfoveal Choroidal Neovascularization (CNV)
Sponsor: Novartis
Enrollment: 234
Locations: 3
Primary Endpoint: Safety assessed by incidence and severity of treatment emergent ocular and non-ocular adverse events over 24 month study period with ranibizumab monthly prn (0.5mg/0.05ml)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This extension study will investigate the long-term safety and tolerability of multiple intravitreal injections of ranibizumab administered to patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration who have been previously treated in either of the two ongoing ranibizumab studies CRFB002A2302 (EXCITE) or CRFB002A2303 (SUSTAIN

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

January 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Completion of 12-month treatment period of study CRFB002A2302 (EXCITE) or CRFB002A2303

Exclusion Criteria

•Concurrent participation in another clinical trial, i.e. use of other investigational drugs

Arms & Interventions

1

ranibizumab

Intervention: ranibizumab

Outcomes

Primary Outcomes

Safety assessed by incidence and severity of treatment emergent ocular and non-ocular adverse events over 24 month study period with ranibizumab monthly prn (0.5mg/0.05ml)

Secondary Outcomes

Efficacy assessed by mean change in BCVA from Baseline at M 6, 12, 18, and 24. Number of injections with ranibizumab. Safety assessed by AEs and SAEs leading to premature discont. of study drug, vital signs, and ophthalmic exams.