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OpenTrials
Completed

NCT Number: NCT00942864

Effect of Intravitreal Ranibizumab Injection With 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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Key information

Conditions

Macular Edema Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dept. of ophthalmology, Kyung Hee University Medical Center

Seoul, 130-702, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

ranibizumab 0.5mg (0.05ml volume), intravitreal injection first 3 injection every 4 weeks additional injection (optional) according to the judgement of doctor

Other names: Lucentis®

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.

    Time frame: 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).

    Time frame: every 4 weeks (up to 52 weeks)

Sponsors and collaborators

Lead sponsor

Novartis Korea Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 21, 2009
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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