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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00504959




Registration number
NCT00504959
Ethics application status
Date submitted
19/07/2007
Date registered
20/07/2007
Date last updated
4/03/2016

Titles & IDs
Public title
Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Scientific 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)
Secondary ID [1] 0 0
CRFB002A2402
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subfoveal Choroidal Neovascularization (CNV) 0 0
Secondary to Age-related Macular Degeneration (AMD) 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 1 - ranibizumab
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Completion of 12-month treatment period of study CRFB002A2302 (EXCITE) or CRFB002A2303
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Concurrent participation in another clinical trial, i.e. use of other investigational drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
Accrual to date
Final
234
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Laeken
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Belgium
State/province [3] 0 0
Liege
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Bonn
Country [6] 0 0
Germany
State/province [6] 0 0
Bremen
Country [7] 0 0
Germany
State/province [7] 0 0
Chemnitz
Country [8] 0 0
Germany
State/province [8] 0 0
Duesseldorf
Country [9] 0 0
Germany
State/province [9] 0 0
Kiel
Country [10] 0 0
Germany
State/province [10] 0 0
Koeln
Country [11] 0 0
Germany
State/province [11] 0 0
Leipzig
Country [12] 0 0
Germany
State/province [12] 0 0
Marburg
Country [13] 0 0
Germany
State/province [13] 0 0
Muenchen
Country [14] 0 0
Germany
State/province [14] 0 0
Siegburg
Country [15] 0 0
Germany
State/province [15] 0 0
Tubingen
Country [16] 0 0
Germany
State/province [16] 0 0
Wuerzburg
Country [17] 0 0
Hungary
State/province [17] 0 0
Budapest
Country [18] 0 0
Hungary
State/province [18] 0 0
Debrecen
Country [19] 0 0
Israel
State/province [19] 0 0
Petach-Tikva
Country [20] 0 0
Israel
State/province [20] 0 0
Tel - Hashomer
Country [21] 0 0
Israel
State/province [21] 0 0
Tel-Aviv
Country [22] 0 0
Netherlands
State/province [22] 0 0
Amsterdam
Country [23] 0 0
Netherlands
State/province [23] 0 0
Nijmegen
Country [24] 0 0
Portugal
State/province [24] 0 0
Coimbra
Country [25] 0 0
Portugal
State/province [25] 0 0
Porto
Country [26] 0 0
Spain
State/province [26] 0 0
Alicante
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
Santiago de Compostela
Country [30] 0 0
Spain
State/province [30] 0 0
Valencia
Country [31] 0 0
Turkey
State/province [31] 0 0
Ankara
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Bristol
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Southampton
Country [34] 0 0
United Kingdom
State/province [34] 0 0
West Midlands
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT00504959
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Novartis
Address 0 0
Board of Hacettepe University , Ankara, turkey
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00504959