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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Novartis Korea Ltd.
ClinicalTrials.gov Identifier:
NCT00942864
First received: July 17, 2009
Last updated: July 21, 2009
Last verified: July 2009
History of Changes

July 17, 2009
July 21, 2009
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00942864 on ClinicalTrials.gov 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) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
Not Provided
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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00942864
CRFB002AKR07
Not Provided
Seung Young Yu / assistant professor, dept. of ophthalmology, Kyunghee medical center
Novartis Korea Ltd.
Not Provided
Principal Investigator: Seung-Young Yu Dept. ophthalmology, Kyunghee medical center
Novartis Korea Ltd.
July 2009

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