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| ID | Type | Description | Link |
|---|---|---|---|
| Health Canada Control #106990 | |||
| 9427-U0207/2-21C |
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| Name | Class |
|---|---|
| QLT Inc. | INDUSTRY |
| Canadian Retinal Trials Group | OTHER |
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The primary purpose of the study is to investigate whether patients with Choroidal Neovascularization secondary to Age-related Macular Degeneration, receiving triple or double therapy compared to monotherapy with Avastin will reduce the intervention rate with equivalent safety and efficacy.
Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in developed countries throughout the world.The beneficial therapeutic effect of Photodynamic Therapy (PDT)in the treatment of AMD is modest. The treatment benefit of PDT may be moderated by PDT-induced, non-selective effects in the choroidal circulation (resulting in hypoxia-induced stimulation of angiogenesis through increased vascular endothelial growth factor (VEGF)production), direct injury to the retinal pigment epithelium, and subretinal fluid/hemorrhage or post-treatment inflammation secondary to PDT. There is potential that supplemental Avastin (through VEGF inhibition) or intravitreal Triamcinolone Acetonide (ITA) treatments (through non-specific membrane stabilizing, anti-neovascular, and anti-inflammatory activities) could minimize the effect of these processes, enhancing the efficacy of PDT. Presently, PDT, the current gold standard,in combination with Avastin and/or Kenalog is being more widely used in exactly this fashion and may become the standard of care without the necessary randomized clinical trial. However, the treatment benefit of these interventions is uncertain as is their safety profile.
This randomized, controlled trial addresses the potential supplemental therapeutic effect of intravitreal injection of Triamcinolone Acetonide and/or Avastin in conjunction with photodynamic therapy for the treatment of sub-foveal CNVM secondary to AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Reduced fluence PDT plus intravitreal Kenalog (2 mg) plus intravitreal Avastin 1.25 mg |
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| 2 | Experimental | Reduced fluence PDT plus intravitreal Avastin |
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| 3 | Experimental | Intravitreal Avastin and sham reduced fluence PDT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avastin (Bevacizumab) | Drug | Avastin 1.25 mg intravitreal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate whether patients with CNV secondary to AMD, receiving triple or double therapy compared to monotherapy with Avastin, will reduce the intervention rate with equivalent safety and efficacy. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To compare between treatment groups: | 1 year | |
| Whether combination therapy with rPDT + iA and rPDT + iAK in patients with sub-foveal CNVM of all types secondary to ARMD will result in a significant improvement in visual acuity defined as 2 or more lines (10+ letters) on a standardized ETDRS chart c |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas G. Sheidow, MD | The University of Western Ontario | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alberta and Capital Health | Edmonton | Alberta | T5H 3V9 | Canada | ||
| The University of British Columbia |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab |
| Drug |
Intravitreal 1.25 mg |
|
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| Bevacizumab | Drug | Intravitreal 1.25 mg |
|
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| Bevacizumab | Drug | Intravitreal Avastin 1.25 mg and sham reduced fluence PDT |
|
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| 1 year |
| Lesion growth and activity over the study period. | 1 year |
| Contrast sensitivity. | 1 year |
| The rate of cataract progression. | 1 year |
| Central retinal thickness via Optical Coherence Tomography (OCT). | 1 year |
| Vancouver |
| British Columbia |
| V5Z 3N9 |
| Canada |
| Dr. Stanley G. Shortt | Victoria | British Columbia | V8V 4X3 | Canada |
| Ivey Eye Institute, St. Joseph's Health Care Centre | London | Ontario | N6A 4G5 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4M 3M5 | Canada |
| D014603 |
| Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |