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This is a multicenter, randomized, open-label study. 40 patients will be followed for a period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg of intravitreal ranibizumab injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen 1 | Active Comparator | Intravitreal injection of Ranibizumab monthly for 12 months. |
|
| Regimen 2 | Active Comparator | Intravitreal injection of ranibizumab for 4 months (at Day 0, Month 1, Month 2, and Month 3) followed by by treatments on predefined re-treatment criteria. |
|
| Regimen 3 | Active Comparator | Intravitreal injection of Ranibizumab 2.0mg monthly for 12 months |
|
| Regimen 4 | Active Comparator | Intravitreal injection 2.0mg ranibizumab for 4 months (at Day 0, Month 1 and Month 2, and Month 3) followed by PRN treatments on pre-defined re-treatment criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | 0.5 mg of intravitreal ranibizumab monthly for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Best Corrected Visual Acuity from baseline measured at 4 meters on the ETDRS chart at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of eyes reaching BCVA greater than or equal to 20/200 | 12 months | |
| Proportion of eyes gaining greater than or equal to 0, 5, 10, and 15 letters on the ETDRS chart | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clement K Chan, M.D. | Southern California Desert Retina Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Stein Eye Institute | Los Angeles | California | 90095 | United States | ||
| Southern California Desert Retina Consultants |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25277305 | Derived | Chan CK, Abraham P, Sarraf D, Nuthi AS, Lin SG, McCannel CA. Earlier therapeutic effects associated with high dose (2.0 mg) Ranibizumab for treatment of vascularized pigment epithelial detachments in age-related macular degeneration. Eye (Lond). 2015 Jan;29(1):80-7. doi: 10.1038/eye.2014.233. Epub 2014 Oct 3. |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| D020256 | Choroidal Neovascularization |
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ranibizumab | Drug | 0.5 mg intravitreal injection of ranibizumab for 4 months followed by PRN dosing |
|
|
| Ranibizumab | Drug | 2.0mg of intravitreal ranibizumab monthly for 12 months |
|
|
| Ranibizumab | Drug | 2.0mg of intravitreal injection of Ranibizumab for 4 months followed by PRN dosing |
|
|
| Reduction in central macular thickness from baseline (central 1-mm subfield) as measured by an OCT |
| 12 months |
| Changes in choroidal neovascular lesion (CNV)size on fluorescein angiography and fundus photography from baseline | 12 months |
| Changes in retinal pigment epithelial detachment size on fluorescein angiography and fundus photography, including height of the PED and associated submacular fluid on OCT in comparison to baseline | 12 months |
| Status of fluorescein staining or leakage (increased or decreased) from baseline | 12 months |
| Ocular safety outcome including ocular complication, i.e. RPE tears, uveitis, endophthalmitis | 12 months |
| Systemic safety outcome including cardiovascular event, cerebral vascular events | 12 months |
| Proportion of patients with an improvement from baseline in Contrast Sensitivity at 24 and 48 weeks | 24 and 48 weeks |
| Proportion of patients with an improvement from baseline in the VFQ overall composite score and near and distance activities subscales at 24 and 48 weeks | 24 and 48 weeks |
| Palm Desert |
| California |
| 92211 |
| United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| 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 |