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Evaluation of the Usefulness of a PRN Regimen Using Ranibizumab for Macular Edema Due to Branch Retinal Vein Occlusion

Primary Purpose

Branch Retinal Vein Occlusion

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
Nagoya City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Branch Retinal Vein Occlusion focused on measuring ranibizumab, PRN regimen, macular edema, branch retinal vein occlusion

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent form
  • Macula edema secondary to BRVO
  • BCVA of 77 to 20 letters assessed with the use of ETDRS charts
  • CRT ≧250μm

Exclusion Criteria:

  • Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO
  • Ocular disorders in the study eye that may confound interpretation of study results
  • BCVA over 77 letters between screening and Day 0
  • The pregnant or lactating woman

Sites / Locations

  • Nagoya City Univsersity

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraviteal Ranibizumab 0.5mg

Arm Description

Intraviteal Ranibizumab 0.5mg

Outcomes

Primary Outcome Measures

Visual acuity

Secondary Outcome Measures

central foveal thickness
Visual acuity

Full Information

First Posted
January 26, 2015
Last Updated
August 17, 2019
Sponsor
Nagoya City University
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02478515
Brief Title
Evaluation of the Usefulness of a PRN Regimen Using Ranibizumab for Macular Edema Due to Branch Retinal Vein Occlusion
Official Title
Evaluation of Visual Acuity Improvement of a PRN Regimen Using Ranibizumab for Macular Edema Due to Ischemic and Non- Ischemic Branch Retinal Vein Occlusion.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nagoya City University
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Monthly intravitreal ranibizumab (IVR) during the first 6 month had great effect for macular edema with branch retinal vein occlusion (BVO) both in visual and anatomical outcome. It is expected that similar results could be obtained by less frequent IVR. The purpose of this study is to investigate if IVR by PRN is as effective as by monthly. In addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area.
Detailed Description
It was demonstrated in BRAVO study that IVR had great effect for macular edema with BVO both in visual and anatomical outcome. However IVR was done monthly for all patients (except Sham group) during the first 6 months in BRAVO study. It is expected that similar results could be obtained by less frequent IVR, and if so, it will contribute to reduce patient's burden and medical cost. Thus it is necessary to determine the optimal regimen of IVR therapy. In this study, considering the medical and social circumstances in Japan, the investigators are going to investigate if IVR by PRN is as effective as BRAVO study.In addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area (NPA), because VEGF is thought to be released from non-perfused retinal tissue, and VEGF production may be correlated with NPA size and location. The investigators are going to measure the size of NPA semi-quantatively by ultra wide field fluorescein angiography (UWFA) using Optos 200Tx. Then the relationship with macular edema will be studied. The effect of ranibizumab to NPA is controversial. In this study, it will be investigated, too.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Retinal Vein Occlusion
Keywords
ranibizumab, PRN regimen, macular edema, branch retinal vein occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraviteal Ranibizumab 0.5mg
Arm Type
Experimental
Arm Description
Intraviteal Ranibizumab 0.5mg
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Intraviteal injection of 0.5mg ranibizumab
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
One years
Secondary Outcome Measure Information:
Title
central foveal thickness
Time Frame
One and two years
Title
Visual acuity
Time Frame
Two years
Other Pre-specified Outcome Measures:
Title
size and location of retinal non-perfusion area
Time Frame
one and two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent form Macula edema secondary to BRVO BCVA of 77 to 20 letters assessed with the use of ETDRS charts CRT ≧250μm Exclusion Criteria: Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye) History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO Ocular disorders in the study eye that may confound interpretation of study results BCVA over 77 letters between screening and Day 0 The pregnant or lactating woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuichiro Ogura
Organizational Affiliation
Nagoya City Univsersity
Official's Role
Study Chair
Facility Information:
Facility Name
Nagoya City Univsersity
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Usefulness of a PRN Regimen Using Ranibizumab for Macular Edema Due to Branch Retinal Vein Occlusion

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