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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00942864
First Posted: July 21, 2009
Last Update Posted: September 29, 2016
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.
Information provided by (Responsible Party):
Novartis ( Novartis Korea Ltd. )
  Purpose
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).

Condition Intervention Phase
Macular Edema Retinal Vein Occlusion Drug: ranibizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Korea Ltd. ):

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. [ Time Frame: every 4 weeks (up to 52 weeks) ]

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). [ Time Frame: every 4 weeks (up to 52 weeks) ]

Enrollment: 40
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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®
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942864


Locations
Korea, Republic of
Dept. of ophthalmology, Kyung Hee University Medical Center
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Novartis Korea Ltd.
Investigators
Principal Investigator: Seung-Young Yu Dept. ophthalmology, Kyunghee medical center
  More Information

Responsible Party: Novartis Korea Ltd.
ClinicalTrials.gov Identifier: NCT00942864     History of Changes
Other Study ID Numbers: CRFB002AKR07
First Submitted: July 17, 2009
First Posted: July 21, 2009
Last Update Posted: September 29, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents