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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Active Comparator | Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs. |
|
| Group 2 | Active Comparator | Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | 0.5mg injection monthly according to protocol for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in visual acuity from baseline over 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to OCT resolution of macular edema and pigment epithelial detachment | One year | |
| Proportion of patients with complete resolution of PED at 6 and 12 months | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.
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| Name | Affiliation | Role |
|---|---|---|
| Anne Fung, MD | Pacific Eye Associates / California Pacific Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Eye Associates | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17386270 | Background | Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW Jr, Esquiabro M. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):566-83. doi: 10.1016/j.ajo.2007.01.028. |
| Label | URL |
|---|---|
| Pacific Eye Associates website | View source |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012163 | Retinal Detachment |
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye 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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| Durability of outcome: time from last ranibizumab injection to retreatment |
| One year |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |