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The purpose of this research study is to compare different timing therapies of Verteporfin with Bevacizumab to treat choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verteporfin | Drug | |||
| Bevacizumab | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients losing 3 or more lines of visual acuity | ||
| percentage of patients gaining 3 or more lines of visual acuity | ||
| mean change from baseline in visual acuity | ||
| OCT evidence of active CNV leakage | ||
| fluorescein angiographic evidence of active CNV leakage | ||
| number of retreatments |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who have received previous treatment for subfoveal CNV, in their study eye including prior PDT, transpupillary thermotherapy (TTT), submacular surgery, drug therapies such as Macugen or other anti-angiogenic compounds, or other local treatment. Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
Patients with a known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light.
Patients who use medications that may induce photosensitivity.
Patients who have undergone YAG capsulotomy within the last month.
Subjects currently involved in any experimental procedure within the last 12 weeks.
Female patients who are pregnant, fecund or breast-feeding.
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| Name | Affiliation | Role |
|---|---|---|
| Joel A Pearlman, M.D., Ph. D. | Retinal Consultants Medical Group, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants Medical Group, Inc. | Sacramento | California | 95819 | United States |
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| 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 |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| 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 |