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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169648
Recruitment Status : Unknown
Verified June 2014 by Hidetaka Noma, Tokyo Medical University.
Recruitment status was:  Recruiting
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Hidetaka Noma, Tokyo Medical University

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.

Condition or disease Intervention/treatment Phase
Macular Edema Branch Retinal Vein Occlusion Central Retinal Vein Occlusion Drug: ranibizumab Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: ranibizumab
Experimental: Intravitreal injection of Ranibizumab
Drug: ranibizumab
intravitreal injection of 0.50 mg (0.05ml) ranibizumab monthly as needed.
Other Name: Lucentis




Primary Outcome Measures :
  1. Visual function by ranibizumab in macular edema with retnal vein occlusion [ Time Frame: one year ]
    Mean change in central retinal thickness (CRT) and best corrected visual acuity (BCVA) at month 12


Secondary Outcome Measures :
  1. Cytokine levels by ranibizumab in macular edema with retnal vein occlusion [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169648


Contacts
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Contact: Hidetaka Noma, MD, PhD 81-42-665-5611 ext 7648 noma-hide@umin.ac.jp

Locations
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Japan
Hachioji Medical Center, Tokyo Medical University Recruiting
Tokyo, Japan, 193-0998
Principal Investigator: Hidetaka Noma, MD, PhD         
Hachioji Medical Center, Tokyo Medical University Recruiting
Tokyo, Japan, 193-0998
Contact: Hidetaka Noma, MD, PhD    81-42-665-5611 ext 7648    noma-hide@umin.ac.jp   
Principal Investigator: Hidetaka Noma, MD, PhD         
Sponsors and Collaborators
Tokyo Medical University
Investigators
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Principal Investigator: Hidetaka Noma, MD Hachioji Medical Center, Tokyo Medical University
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Responsible Party: Hidetaka Noma, Department of Ophthalmology, Hachioji Medical Center, Tokyo Medical University
ClinicalTrials.gov Identifier: NCT02169648    
Other Study ID Numbers: H-4
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by Hidetaka Noma, Tokyo Medical University:
macular edema
branch retinal vein occlusion
central retinal vein occlusion
ranibizumab
cytokines
visual acuity
central macular thickness
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents