Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)
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)
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 17, 2009
CompletedFirst Posted
Study publicly available on registry
July 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedSeptember 29, 2016
September 1, 2016
1 year
July 17, 2009
September 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
every 4 weeks (up to 52 weeks)
Secondary Outcomes (1)
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).
every 4 weeks (up to 52 weeks)
Interventions
ranibizumab 0.5mg (0.05ml volume), intravitreal injection first 3 injection every 4 weeks additional injection (optional) according to the judgement of doctor
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of ophthalmology, Kyung Hee University Medical Center
Seoul, 130-702, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Young Yu
Dept. ophthalmology, Kyunghee medical center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2009
First Posted
July 21, 2009
Study Start
December 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
September 29, 2016
Record last verified: 2016-09