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

Primary Purpose

Macular Edema, Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion

Status

Unknown status

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

ranibizumab

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring macular edema, branch retinal vein occlusion, central retinal vein occlusion, ranibizumab, cytokines, visual acuity, central macular thickness

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hachioji Medical Center, Tokyo Medical UniversityRecruiting
Hachioji Medical Center, Tokyo Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ranibizumab

Arm Description

Experimental: Intravitreal injection of Ranibizumab

Outcomes

Primary Outcome Measures

Visual function by ranibizumab in macular edema with retnal vein occlusion

Mean change in central retinal thickness (CRT) and best corrected visual acuity (BCVA) at month 12

Secondary Outcome Measures

Cytokine levels by ranibizumab in macular edema with retnal vein occlusion

Correlation between cytokine levels and mean change in CRT and/or BCVA at month 3, 6, 12, Correlation between cytokine levels and number of ranibizumab injections at month 6, 12

Full Information

NCT ID

NCT02169648

First Posted

June 13, 2014

Last Updated

June 18, 2014

Sponsor

Tokyo Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02169648

Brief Title

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

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tokyo Medical University

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ranibizumab

Arm Type

Experimental

Arm Description

Experimental: Intravitreal injection of Ranibizumab

Intervention Type

Drug

Intervention Name(s)

ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual function by ranibizumab in macular edema with retnal vein occlusion

Description

Mean change in central retinal thickness (CRT) and best corrected visual acuity (BCVA) at month 12

Time Frame

one year

Secondary Outcome Measure Information:

Title

Cytokine levels by ranibizumab in macular edema with retnal vein occlusion

Description

Correlation between cytokine levels and mean change in CRT and/or BCVA at month 3, 6, 12, Correlation between cytokine levels and number of ranibizumab injections at month 6, 12

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hidetaka Noma, MD, PhD

Phone

81-42-665-5611

Ext

7648

noma-hide@umin.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hidetaka Noma, MD

Organizational Affiliation

Hachioji Medical Center, Tokyo Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hachioji Medical Center, Tokyo Medical University

City

Tokyo

ZIP/Postal Code

193-0998

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hidetaka Noma, MD, PhD

Facility Name

Hachioji Medical Center, Tokyo Medical University

City

Tokyo

ZIP/Postal Code

193-0998

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hidetaka Noma, MD, PhD

Phone

81-42-665-5611

Ext

7648

noma-hide@umin.ac.jp

First Name & Middle Initial & Last Name & Degree

Hidetaka Noma, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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