Development of Intravitreal Ranibizumab by Determining the Pathogenesis of Macular Edema With Retinal Vein Occlusion

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Study on the Correlation Between the Treatment Effectiveness of Ranibizumab and the Role of the Cytokines in Macular Edema With Retinal Vein Occlusion

Conditions
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Macular Edema, Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion

Intervention / Treatment
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* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Foveal thickness > 300 μm Best corrected visual acuity < 20/30 Exclusion Criteria: History of retinal diseases other than BRVO, glaucoma, uveitis, diabetes mellitus, rubeosis iridis, ocular infections, laser photocoagulation, and intraocular surgery

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ranibizumab<br>Experimental: Intravitreal injection of Ranibizumab | Drug: ranibizumab<br>* intravitreal injection of 0.50 mg (0.05ml) ranibizumab monthly as needed.<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine levels by ranibizumab in macular edema with retnal vein occlusion | Correlation between cytokine levels and mean change in CRT and/or BCVA at month 3, 6, 12, Correlation between cytokine levels and number of ranibizumab injections at month 6, 12 | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular edema, branch retinal vein occlusion, central retinal vein occlusion, ranibizumab, cytokines, visual acuity, central macular thickness