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

NCT ID: NCT02169648

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-12-31

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

Conditions

Macular Edema; Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ranibizumab

Experimental: Intravitreal injection of Ranibizumab

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

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

Interventions

ranibizumab

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

Intervention Type: DRUG

Other Intervention Names

Lucentis

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokyo Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hidetaka Noma

Department of Ophthalmology, Hachioji Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hidetaka Noma, MD

Role: PRINCIPAL_INVESTIGATOR

Hachioji Medical Center, Tokyo Medical University

Locations

Hachioji Medical Center, Tokyo Medical University

Tokyo, , Japan

Site Status: RECRUITING

Hachioji Medical Center, Tokyo Medical University

Tokyo, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Hidetaka Noma, MD, PhD

Role: CONTACT

noma-hide@umin.ac.jp

81-42-665-5611 ext. 7648

Facility Contacts

Hidetaka Noma, MD, PhD

Role: primary

noma-hide@umin.ac.jp

81-42-665-5611 ext. 7648

Other Identifiers

H-4

Identifier Type: -

Identifier Source: org_study_id