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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
intravitreal injection of 0.50 mg (0.05ml) ranibizumab monthly as needed.
Hachioji Medical Center, Tokyo Medical University
Tokyo, Japan
RECRUITINGHachioji Medical Center, Tokyo Medical University
Tokyo, Japan
RECRUITINGVisual 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
Time frame: one year
Cytokine levels by ranibizumab in macular edema with retnal vein occlusion
1. Correlation between cytokine levels and mean change in CRT and/or BCVA at month 3, 6, 12, 2. Correlation between cytokine levels and number of ranibizumab injections at month 6, 12
Time frame: one year
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