Clinical trial NCT00504959: Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subfoveal Choroidal Neovascularization (CNV)
Secondary to Age-related Macular Degeneration (AMD)
Keywords: Age-related macular degeneration (AMD),
choroidal neovascularization (CNV),
vascular endothelial growth factor (VEGF)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 234
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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:
measure: 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.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Novartis Investigational Site
city: Laeken
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Siegburg
country: Germany
facility: Novartis Investigative Site
city: Tubingen
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Petach-Tikva
country: Israel
facility: Novartis Investigative Site
city: Tel - Hashomer
country: Israel
facility: Novartis Investigative Site
city: Tel-Aviv
country: Israel
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Nijmegen
country: Netherlands
facility: Novartis Investigative Site
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Alicante
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative SIte
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Southampton
country: United Kingdom
facility: Novartis Investigative Site
city: West Midlands
country: United Kingdom
facility: Novartis Investigative Site
city: Wolverhampton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Board of Hacettepe University , Ankara, turkey
name: Novartis
role: STUDY_CHAIR
References:
citation: Silva R, Axer-Siegel R, Eldem B, Guymer R, Kirchhof B, Papp A, Seres A, Gekkieva M, Nieweg A, Pilz S; SECURE Study Group. The SECURE study: long-term safety of ranibizumab 0.5 mg in neovascular age-related macular degeneration. Ophthalmology. 2013 Jan;120(1):130-9. doi: 10.1016/j.ophtha.2012.07.026. Epub 2012 Sep 25.