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

Not Applicable

• Conditions: Macular Edema; Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion
• Interventions: Drug: ranibizumab

• Registration Number: NCT02169648
• Lead Sponsor: Tokyo Medical University

Brief 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.

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

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-06
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-18
• Last Update Submitted: 2014-06-18
• Study First Posted: 2014-06-23
• Last Update Posted: 2014-06-23
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ranibizumab	ranibizumab	Experimental: Intravitreal injection of Ranibizumab

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cytokine levels by ranibizumab in macular edema with retnal vein occlusion	one year	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

Trial Locations

Locations (1)

Hachioji Medical Center, Tokyo Medical University; 🇯🇵 Tokyo, Japan