Development of Intravitreal Ranibizumab by Determining the Pathogenesis of Macular Edema With Retinal Vein Occlusion
Information source: Tokyo Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Edema; Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion
Intervention: ranibizumab (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Tokyo Medical University Official(s) and/or principal investigator(s): Hidetaka Noma, MD, Principal Investigator, Affiliation: Hachioji Medical Center, Tokyo Medical University
Overall contact: Hidetaka Noma, MD, PhD, Phone: 81-42-665-5611, Ext: 7648, Email: noma-hide@umin.ac.jp
Summary
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.
Clinical Details
Official title: Study on the Correlation Between the Treatment Effectiveness of Ranibizumab and the Role of the Cytokines in Macular Edema With Retinal Vein Occlusion
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Visual function by ranibizumab in macular edema with retnal vein occlusion
Secondary outcome: Cytokine levels by ranibizumab in macular edema with retnal vein occlusion
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
Eligibility
Minimum age: 30 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hidetaka Noma, MD, PhD, Phone: 81-42-665-5611, Ext: 7648, Email: noma-hide@umin.ac.jp
Hachioji Medical Center, Tokyo Medical University, Tokyo 193-0998, Japan; Recruiting Hidetaka Noma, MD, PhD, Principal Investigator
Hachioji Medical Center, Tokyo Medical University, Tokyo 193-0998, Japan; Recruiting Hidetaka Noma, MD, PhD, Phone: 81-42-665-5611, Ext: 7648, Email: noma-hide@umin.ac.jp Hidetaka Noma, MD, PhD, Principal Investigator
Additional Information
Starting date: December 2013
Last updated: June 18, 2014
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