Back to resultsEffect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)
Primary Purpose
Macular Edema, Retinal Vein Occlusion
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema
Eligibility Criteria
Inclusion Criteria:
- Signed written informed consent
- Patients with macular edema due to RVO (confirmed by fundus photography, fluorescein angiography, OCT)
- Male and female aged from 18 to 70
- Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/400 to 20/30 using ETDRS chart
Exclusion Criteria:
- Additional eye disease that could compromise VA
- Ocular inflammation
- Intraocular surgery ≤ 1 month before day 0
- Uncontrolled glaucoma
- Prior treatments with laser photocoagulation or other intervention for macular edema due to BRVO
- Patients aged under 18 or over 71
- Female patient in pregnancy or breast feeding
- Not suitable to regular follow up
Sites / Locations
- Dept. of ophthalmology, Kyung Hee University Medical Center
Outcomes
Primary Outcome Measures
The change in ETDRS visual acuity letter scores from baseline. The change in the 1-mm central retinal thickness as measured by OCT from baseline.
Secondary Outcome Measures
The intraretinal structure changes in OCT. Progression of avascular area by FA. Number of additional treatments. Intraocular safety (endophthalmitis, uveitis, increase in intraocular pressure, etc).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00942864
Brief Title
Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)
Official Title
An Open-label, Nonrandomized, Phase IIIb, Single Dose Study to Evaluated the Changes in Optical Coherence Tomography (OCT) and Fluorescein Angiography (FA) After Intravitreal Injection of Lucentis® in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Korea Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of intravitreal Lucentis® (Ranibizumab) and investigate the anatomical and functional improvement following this treatment in patients with macular edema due to retinal vein occlusion (RVO).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
ranibizumab 0.5mg (0.05ml volume), intravitreal injection first 3 injection every 4 weeks additional injection (optional) according to the judgement of doctor
Primary Outcome Measure Information:
Title
The change in ETDRS visual acuity letter scores from baseline. The change in the 1-mm central retinal thickness as measured by OCT from baseline.
Time Frame
every 4 weeks (up to 52 weeks)
Secondary Outcome Measure Information:
Title
The intraretinal structure changes in OCT. Progression of avascular area by FA. Number of additional treatments. Intraocular safety (endophthalmitis, uveitis, increase in intraocular pressure, etc).
Time Frame
every 4 weeks (up to 52 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed written informed consent
Patients with macular edema due to RVO (confirmed by fundus photography, fluorescein angiography, OCT)
Male and female aged from 18 to 70
Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/400 to 20/30 using ETDRS chart
Exclusion Criteria:
Additional eye disease that could compromise VA
Ocular inflammation
Intraocular surgery ≤ 1 month before day 0
Uncontrolled glaucoma
Prior treatments with laser photocoagulation or other intervention for macular edema due to BRVO
Patients aged under 18 or over 71
Female patient in pregnancy or breast feeding
Not suitable to regular follow up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Young Yu
Organizational Affiliation
Dept. ophthalmology, Kyunghee medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of ophthalmology, Kyung Hee University Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)
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