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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due to age-related macular degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. |
|
| B | Experimental | Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline. | 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dante J Pieramici, MD | California Retina Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants | Bakersfield | California | 93309 | United States | ||
| California Retina Consultants |
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| Label | URL |
|---|---|
| California Retina Consultants Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Fluence | Reduced Fluence Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| verteporfin photodynamic therapy reduced fluence | Device | Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2]. |
|
|
| verteporfin photodynamic therapy standardfluence | Device | Patients will receive combination verteporfin with photodynamic therapy at standard fluence [600mw/cm2]. |
|
| Santa Barbara |
| California |
| 93103 |
| United States |
| Standard Fluence |
Standard Fluence Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduced Fluence | Reduced Fluence Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. |
| BG001 | Standard Fluence | Standard Fluence Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| visual acuity | Mean | Standard Deviation | ETDRS letters |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline. | Posted | Number | percent of participants | 1 Year |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduced Fluence | Reduced Fluence Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. | 0 | 11 | 0 | 11 | ||
| EG001 | Standard Fluence | Standard Fluence Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy. | 0 | 11 | 0 | 11 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | California Retina Consultants | 8059631648 | 3034 | gabe@californiaretina.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| D008269 | Macular Edema |
| 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 |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077362 | Verteporfin |
| 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 |
| 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 |
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| Male |
|