Subfoveal Choroidal Neovascularization (CNV)Phase 4NCT00504959
Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
A Phase 4 study testing ranibizumab in people with Subfoveal Choroidal Neovascularization (CNV) and Secondary to Age-related Macular Degeneration (AMD), run by Novartis at 36 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Subfoveal Choroidal Neovascularization (CNV), Secondary to Age-related Macular Degeneration (AMD)
- What is being tested?
- ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 36 sitesin 10 countries
- Study dates
- Jul 2007to Jan 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of 12-month treatment period of study CRFB002A2302 (EXCITE) or CRFB002A2303
Who cannot join
- Concurrent participation in another clinical trial, i.e. use of other investigational drugs
Trial locations and contacts
36 sites in 10 countries.
36 sites in 10 countries
Germany13 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Bonn
Novartis Investigative Site
Bremen
Novartis Investigative Site
Chemnitz
Novartis Investigative Site
Cologne
Novartis Investigative Site
Düsseldorf
Novartis Investigative Site
Kiel
Novartis Investigative Site
Leipzig
Novartis Investigative Site
Marburg
Novartis Investigative Site
München
Novartis Investigative Site
Siegburg
Novartis Investigative Site
Tübingen
Novartis Investigative Site
Würzburg
Spain5 sites
Novartis Investigative Site
Alicante
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Madrid
Novartis Investigative Site
Santiago de Compostela
Novartis Investigative Site
Valencia
United Kingdom4 sites
Novartis Investigative Site
Bristol
Novartis Investigative Site
Southampton
Novartis Investigative Site
West Midlands
Novartis Investigative Site
Wolverhampton
Belgium3 sites
Novartis Investigative Site
Laken
Novartis Investigative Site
Leuven
Novartis Investigative Site
Liège
Israel3 sites
Novartis Investigative Site
Petah Tikva
Novartis Investigative Site
Tel Aviv
Novartis Investigative Site
Tel HaShomer
Hungary2 sites
Novartis Investigative Site
Budapest
Novartis Investigative Site
Debrecen
Netherlands2 sites
Novartis Investigative Site
Amsterdam
Novartis Investigative Site
Nijmegen
Portugal2 sites
Novartis Investigative Site
Coimbra
Novartis Investigative Site
Porto
About this study
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)
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
- Conditions
- Subfoveal Choroidal Neovascularization (CNV), Secondary to Age-related Macular Degeneration (AMD)
- Being tested
- ranibizumab
- Keywords
- Age-related macular degeneration (AMD),, choroidal neovascularization (CNV),, vascular endothelial growth factor (VEGF)
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called rhuFab V2, Lucentis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ranibizumab Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subfoveal Choroidal Neovascularization (CNV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study chair, Board of Hacettepe University , Ankara, turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504959
- Sponsor's protocol ID
- CRFB002A2402
- Status last verified
- Mar 2016
- First submitted
- 19 Jul 2007
- Last updated
- 4 Mar 2016
- Results posted
- No
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.
PubMed 23021093
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00504959
- Acronym / sponsor ID
- CRFB002A2402
- 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)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ranibizumabranibizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completion of 12-month treatment period of study CRFB002A2302 (EXCITE) or CRFB002A2303
Key exclusion criteria (1 listed)
- Concurrent participation in another clinical trial, i.e. use of other investigational drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ranibizumabAlso: rhuFab V2, Lucentis | Drug | 1 |
Primary outcome
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)
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Derived from this study: PubMed 23021093Silva 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis study chair
Board of Hacettepe University , Ankara, turkey
36 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ranibizumab in people with Subfoveal Choroidal Neovascularization (CNV) and Secondary to Age-related Macular Degeneration (AMD), run by Novartis at 36 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Germany, Spain, United Kingdom, Belgium, Israel and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00504959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.