Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

NCT ID: NCT00383812

Last Updated: 2006-10-04

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-05-31

Brief Summary

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1. Primary objectives

a. To evaluate the Effects of intravitreal Bevacizumab on polypoidal choroidal vasculopathy(PCV)
2. Secondary objectives

1. To assess the changes in visual acuity
2. To assess the change in lesion characteristics of PCV

* size of PCV
* fluorescein leakage
* foveal thickness
3. To investigate the safety of intravitreal Bevacizumab in patients with PCV
4. To assess the effect of intravitreal Bevacizumab on the recurrence rate and the the incidence of submacular hemorrhage in patients with PCV

Detailed Description

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Conditions

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Polypoidal Choroidal Vasculopathy

Keywords

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Polypoidal choroidal vasculopathy Intravitreal Bevacizumab

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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Intravitreal Bevacizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, CNV secondary to PCV
* BCVA of 20/40 to 20/320 (Snellen equivalent)
* Evidence of presumed recent disease progression (blood, growth by FA, or recent VA loss)

Exclusion Criteria

* Uncontrolled glaucoma or any other ocular condition that would prevent an improvement in visual acuity
* Media opacity in the study eye that precludes clinical and photographic evaluation
* Intraocular surgery \< 1 month before day 0
* Use of heparin/warfarin within 1 month prior to injection
* Known allergy or hypersensitivity to fluorescein, indocyanine green or povidone iodine
* Contraindication to pupil dilation in either eye
* Any condition which precludes patients' ability to comply with study requirements including completion of the study
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Young Hee Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

June-Gone Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Sun Young Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Hyewon Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sun Young Lee, MD

Role: CONTACT

Phone: 82-2-3010-3970

Email: [email protected]

Young Hee Yoon, MD

Role: CONTACT

Phone: 82-2-3010-3675

Email: [email protected]

Other Identifiers

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Bevacizumab for PCV

Identifier Type: -

Identifier Source: org_study_id