Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, Macular Edema
Conditions
Keywords
macular edema, branch retinal vein occlusion, central retinal vein occlusion, ranibizumab, cytokines, visual acuity, central macular thickness
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
Interventions
DRUGranibizumab
intravitreal injection of 0.50 mg (0.05ml) ranibizumab monthly as needed.
Sponsors
Tokyo Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Japan
Contacts
Primary ContactHidetaka Noma, MD, PhD
Outcome results
None listed