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

Tokyo Medical University

Status: Unknown

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

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02169648

H-4

Details and patient eligibility

About

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 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

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

ranibizumab

Experimental group

Description:

Experimental: Intravitreal injection of Ranibizumab

Treatment:

Drug: ranibizumab