Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

October 3, 2006 updated by: Asan Medical Center

  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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the percentage of patients who gained an improvement in best corrected visual acuity (BCVA) by 15 letters of more.
To assess the percentage of patients whose final visual acuity resulted in Snellen equivalent of 20/200 or worse

Secondary Outcome Measures

Outcome Measure
To investigate the resolution time of macular edema, subretinal fluid, and/or pigment epithelial detachment (PED) using optical coherence tomography (OCT)
To evaluate change in size and leakage of PCV, using fluorescein angiography (FA) and/or indocyanine angiography (ICGA)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Hyewon Chung, MD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion

May 1, 2008

Study Registration Dates

First Submitted

October 3, 2006

First Submitted That Met QC Criteria

October 3, 2006

First Posted (ESTIMATE)

October 4, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 4, 2006

Last Update Submitted That Met QC Criteria

October 3, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bevacizumab for PCV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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