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The purpose of this research is to use an approved drug(Visudyne) for neovascular age-related macular degeneration, which is essentially choroidal neovascularization for permeability and vascular proliferation for the retinal circulation, to treat another permeable abnormality - retinal capillary abnormalities - located eccentric to the central portion of the macula or in the foveal region.
The study will include 30 patients who were diagnosed with retinal capillary abnormalities and include 2 follow-up visits at 6 and 12 months post-procedure to determine if the treatment has been effective in treating their disorder. It is anticipated that approximately half of the patients will require an additional treatment. Patients will be enrolled from our patient population and be 50 years of age and older, male or female. Pregnant women or women of normal child bearing age will be excluded since there are no adequate and well-controlled studies on the use of photodynamic therapy in pregnant women. Any retinal vascular abnormality that has a standard of care method of treatment will also be excluded from the study population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visudyne | Experimental | Visudyne half fluence- 1 treatment with the possibility of a second treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visudyne | Drug | Half fluence verteporfin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement and/or stabilization of disease. | The drug, approved for are-related macular degeneration should also prove effective for other permeable conditions, such as retinal capillary/vascular abnormalities that lead to macular edemas such as macular telangiectasia type I and type II, retinal arteriolar macroanurysms, and retinal angiomatous proliferation (RAP), which is a variant of neovascular age-related macular degeneration. These diseases currently have no available approved alternative treatment. | 1-2 years |
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Inclusion Criteria:• Individuals that are 50 years of age and older.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence A. Yannuzzi, M.D. | Northshore LIJ/MEETH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitreous Retina Macula Consultants of New York | Recruiting | New York | New York | 10022 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22451952 | Background | Yannuzzi LA, Slakter JS, Gross NE, Spaide RF, Costa DL, Huang SJ, Klancnik JM Jr, Aizman A. Indocyanine green angiography-guided photodynamic therapy for treatment of chronic central serous chorioretinopathy: a pilot study. 2003. Retina. 2012 Feb;32 Suppl 1:288-98. doi: 10.1097/iae.0b013e31823f99a9. |
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| ID | Term |
|---|---|
| D000077362 | Verteporfin |
| ID | Term |
|---|---|
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| 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 |