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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ranibizumab

Experimental: 1 - ranibizumab


Treatment: Drugs: ranibizumab


Intervention code [1] 0 0
Treatment: Drugs
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
Gender
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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/NCT00504959
Trial related presentations / publications
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
Other publications