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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Detailed Description

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

Interventions

  • Drug: ranibizumab
    • intravitreal injection of 0.50 mg (0.05ml) ranibizumab monthly as needed.

Arms, Groups and Cohorts

  • Experimental: ranibizumab
    • Experimental: Intravitreal injection of Ranibizumab

Clinical Trial Outcome Measures

Primary Measures

  • Visual function by ranibizumab in macular edema with retnal vein occlusion
    • Time Frame: one year
    • Mean change in central retinal thickness (CRT) and best corrected visual acuity (BCVA) at month 12

Secondary Measures

  • Cytokine levels by ranibizumab in macular edema with retnal vein occlusion
    • Time Frame: one year
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tokyo Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hidetaka Noma, Department of Ophthalmology, Hachioji Medical Center – Tokyo Medical University
  • Overall Official(s)
    • Hidetaka Noma, MD, Principal Investigator, Hachioji Medical Center, Tokyo Medical University
  • Overall Contact(s)
    • Hidetaka Noma, MD, PhD, 81-42-665-5611, noma-hide@umin.ac.jp

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