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Clinical Trials/NCT00942864
NCT00942864
Completed
Phase 3

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)

Novartis Korea Ltd.1 site in 1 country40 target enrollmentDecember 2008
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ConditionsMacular EdemaRetinal Vein Occlusion
Drugsranibizumab

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Macular Edema
Sponsor
Novartis Korea Ltd.
Enrollment
40
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
December 2009
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

  • 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).(every 4 weeks (up to 52 weeks))

Study Sites (1)

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