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Recently studies have shown that intravitreal injection of ranibizumab is effective for age related macular degeneration. However there are problems about injection regimen of maintenance phase. We plan to perform new simplified treat and extend regimen using ranibizumab.
The purpose of the present study is to evaluate the simplified treat and extend regimen using ranibizumab in eyes with wet age related macular degeneration about best-corrected visual acuity, central retinal thickness, the disappearance rate of the morphological change and treatment continuous rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ranibizumab | Experimental | ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | 0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| A change from baselines best corrected visual acuity at 24 months | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| A drop-out rate of the 3 and 12 months | 3 and 12 months | |
| A treatment continuance rate until 24 months | 24 months | |
| A change of best corrected visual acuity at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mineo Kondo | Mie University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mie University Graduate School of Medicine | Recruiting | Tsu | 5148507 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17021319 | Result | Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655. | |
| 17021318 | Result | Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481. |
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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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| 12 months |
| A change from baselines central retinal thickness measured by spectral domain optical coherence tomography at 12 and 24 months | 12 and 24 months |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |