Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis | Board of Hacettepe University , Ankara, turkey | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigational Site | Melbourne | Australia | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23021093 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Laken |
| Belgium |
| Novartis Investigative Site | Leuven | Belgium |
| Novartis Investigative Site | Liège | Belgium |
| Novartis Investigative Site | Berlin | Germany |
| Novartis Investigative Site | Bonn | Germany |
| Novartis Investigative Site | Bremen | Germany |
| Novartis Investigative Site | Chemnitz | Germany |
| Novartis Investigative Site | Cologne | Germany |
| Novartis Investigative Site | Düsseldorf | Germany |
| Novartis Investigative Site | Kiel | Germany |
| Novartis Investigative Site | Leipzig | Germany |
| Novartis Investigative Site | Marburg | Germany |
| Novartis Investigative Site | München | Germany |
| Novartis Investigative Site | Siegburg | Germany |
| Novartis Investigative Site | Tübingen | Germany |
| Novartis Investigative Site | Würzburg | Germany |
| Novartis Investigative Site | Budapest | Hungary |
| Novartis Investigative Site | Debrecen | Hungary |
| Novartis Investigative Site | Petah Tikva | Israel |
| Novartis Investigative Site | Tel Aviv | Israel |
| Novartis Investigative Site | Tel Litwinsky | Israel |
| Novartis Investigative Site | Amsterdam | Netherlands |
| Novartis Investigative Site | Nijmegen | Netherlands |
| Novartis Investigative Site | Coimbra | Portugal |
| Novartis Investigative Site | Porto | Portugal |
| Novartis Investigative Site | Alicante | Spain |
| Novartis Investigative Site | Barcelona | Spain |
| Novartis Investigative Site | Madrid | Spain |
| Novartis Investigative Site | Santiago de Compostela | Spain |
| Novartis Investigative Site | Valencia | Spain |
| Novartis Investigative SIte | Ankara | Turkey (Türkiye) |
| Novartis Investigative Site | Bristol | United Kingdom |
| Novartis Investigative Site | Southampton | United Kingdom |
| Novartis Investigative Site | West Midlands | United Kingdom |
| Novartis Investigative Site | Wolverhampton | United Kingdom |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided