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

Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02169648
• Other study ID #: H-4
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2014
• Last updated: June 18, 2014
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2014
• Source: Tokyo Medical University
• Contact: Hidetaka Noma, MD, PhD
• Phone: 81-42-665-5611
• Email: noma-hide[@]umin.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Central Retinal Vein Occlusion
• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

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

Locations

Country	Name	City	State
Japan	Hachioji Medical Center, Tokyo Medical University	Tokyo
Japan	Hachioji Medical Center, Tokyo Medical University	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes