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

NCT ID: NCT00942864

Last Updated: 2016-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Macular Edema Retinal Vein Occlusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ranibizumab

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

Intervention Type DRUG

Other Intervention Names

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Lucentis®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Korea Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seung-Young Yu

Role: PRINCIPAL_INVESTIGATOR

Dept. ophthalmology, Kyunghee medical center

Locations

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Dept. of ophthalmology, Kyung Hee University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CRFB002AKR07

Identifier Type: -

Identifier Source: org_study_id

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