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The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis) |
|
| II | Experimental | Treatment with ranibizumab (Lucentis) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| verteporfin (Visudyne) | Drug | Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual change | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of treatment | 18 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nabil M Jabbour, MD | Mid-Atlantic Retina Consultations | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 22, 2013 | |
| Reset | Jun 6, 2013 | |
| Release | Jun 18, 2013 | |
| Reset | Jul 16, 2013 | |
| Release | Oct 24, 2013 | |
| Reset | Dec 12, 2013 | |
| Release | Dec 12, 2013 | |
| Reset | Jan 27, 2014 | |
| Release | Oct 24, 2014 | |
| Reset | Oct 29, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 22, 2013 | Jun 6, 2013 | |||
| Jun 18, 2013 |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
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| ID | Term |
|---|---|
| D000077362 | Verteporfin |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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|
| ranibizumab (Lucentis) | Drug | ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33&37 per study protocol |
|
|
| Jul 16, 2013 |
| Oct 24, 2013 | Dec 12, 2013 |
| Dec 12, 2013 | Jan 27, 2014 |
| Oct 24, 2014 | Oct 29, 2014 |
| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| 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 |
| 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 |