Clinical trial NCT02169648: Development of Intravitreal Ranibizumab by Determining the Pathogenesis of Macular Edema With Retinal Vein Occlusion
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Edema
Branch Retinal Vein Occlusion
Central Retinal Vein Occlusion
Keywords: macular edema
branch retinal vein occlusion
central retinal vein occlusion
ranibizumab
cytokines
visual acuity
central macular thickness
Lead sponsor: Tokyo Medical University
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Visual function by ranibizumab in macular edema with retnal vein occlusion
timeFrame: one year
Secondary outcomes:
measure: Cytokine levels by ranibizumab in macular edema with retnal vein occlusion
timeFrame: one year
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Hachioji Medical Center, Tokyo Medical University
city: Tokyo
country: Japan
facility: Hachioji Medical Center, Tokyo Medical University
Study officials:
affiliation: Hachioji Medical Center, Tokyo Medical University
name: Hidetaka Noma, MD
role: PRINCIPAL_INVESTIGATOR
References: