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The purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by determining the pathogenesis of macular edema, which cause a direct effect on visual function. In particular, we focus on the correlation between the treatment effectiveness of ranibizumab and the role of the cytokines involved in the cause of macular edema.
Methodology:
Aqueous humor samples (0.1ml) were obtained during intravitreous injection of ranibizumab to measure the levels of cytokines. Targeted cytokines are follows; IL-1, IL-2, IL-6, IL-8, IL-9, IL-10, IL-12, IL-13, IP-10, MCP-1, MMP-1, MIP-1β, PDGF, VEGF, PlGF, ICAM-1, TNF-α, RANTES, VEGFR-1, VEGFR-2, which has been reported that the expression level is increased in macular edema associated with RVO. Cytokines are measured by multiple ELISA (Luminex). Aqueous humor samples are obtained in the same manner from patients recurred after the first injection or continuous monthly injections. Statistical analysis is conducted to examine the difference of cytokine levels between early or late/incomplete responders of ranibizumab, and predict the number of injections to stabilize cytokine levels.
Number of centers & patients: Single center, 100 patients
Sample size justification: Sample size calculation was not done, since this study is a single-arm, observational study.
Population: Inclusion criteria: patients with RVO and macular edema
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ranibizumab | Experimental | Experimental: Intravitreal injection of Ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | intravitreal injection of 0.50 mg (0.05ml) ranibizumab monthly as needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual function by ranibizumab in macular edema with retnal vein occlusion | Mean change in central retinal thickness (CRT) and best corrected visual acuity (BCVA) at month 12 | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine levels by ranibizumab in macular edema with retnal vein occlusion |
| one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hidetaka Noma, MD, PhD | Contact | 81-42-665-5611 | 7648 | noma-hide@umin.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Hidetaka Noma, MD | Hachioji Medical Center, Tokyo Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hachioji Medical Center, Tokyo Medical University | Recruiting | Tokyo | 193-0998 | Japan |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| 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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| Hachioji Medical Center, Tokyo Medical University | Recruiting | Tokyo | 193-0998 | Japan |
|
| D020246 |
| Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |