Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)

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. Identifier: NCT00942864
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : September 29, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Korea Ltd. )

July 17, 2009
July 21, 2009
September 29, 2016
December 2008
December 2009   (Final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT00942864 on Archive Site
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) ]
Same as current
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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)
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).
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Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Macular Edema
  • Retinal Vein Occlusion
Drug: ranibizumab
ranibizumab 0.5mg (0.05ml volume), intravitreal injection first 3 injection every 4 weeks additional injection (optional) according to the judgement of doctor
Other Name: Lucentis®
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Novartis ( Novartis Korea Ltd. )
Novartis Korea Ltd.
Not Provided
Principal Investigator: Seung-Young Yu Dept. ophthalmology, Kyunghee medical center
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP