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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006760-28 | EudraCT Number |
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Ranibizumab has been proven to be effective in large multicentre studies. However, the injections have to be repeated monthly. A combined therapy with the established photodynamic therapy might even be more effective, less intravitreal injections might be necessary due to a synergistic effect.
The study will be conducted to explore whether intravitreal ranibizumab in monotherapy or in combination with verteporfin photodynamic therapy under a new time regime is an effective, safe and convenient treatment for patients with subfoveal Choroidal Neovascularisation (CNV) secondary to Age-Related Macular Degeneration (AMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monotherapy arm | Active Comparator | patients receiving 3 initial Ranibizumab injections, thereafter as needed |
|
| combined treatment arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | intravitreal injection 3 monthly injections thereafter as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of injections | Comparision of the number of required retreatments between the groups | baseline-month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| number of AE, SAE | number of AE and SAE | 12 months |
| central retinal thickness | central retinal thickness measured by OCT | baseline-month 12 |
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Inclusion Criteria:
BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart measured at 4 meters or Snellen equivalent
CNV lesion of any type in the study eye which meets all the following characteristics as determined by fluorescein angiography:
For occult with no classic CNV, additionally recent disease progression as assessed by the Investigator is required defined as having at least one of the following criteria:
Willing to return for scheduled visits for a 12 month period
Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilse Krebs, MD | Ludwig Boltzmann Institute for retinology and biomicroscopic Lasersurgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of OPhthalmology Medical center east | Vienna | State of Vienna | A1030 | Austria | ||
| Department of Ophthalmology Rudolf foundation Clinic |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D000077362 | Verteporfin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Verteporfin | Drug | Verteporfin photodynamic therapy standard fluence |
|
| distance acuity | change of disance acuity measured by ETDRS letter scores | baseline-month 12 |
| Vienna |
| State of Vienna |
| A1030 |
| Austria |
| Department of Ophthalmology, Hospital Hietzing | Vienna | State of Vienna | A1030 | Austria |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |