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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: December 2008
Estimated 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Seung Young Yu / assistant professor, dept. of ophthalmology, Kyunghee medical center
ClinicalTrials.gov Identifier: NCT00942864     History of Changes
Other Study ID Numbers: CRFB002AKR07
Study First Received: July 17, 2009
Last Updated: July 21, 2009
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013