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Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intravitreal Bevacizumab
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy focused on measuring Polypoidal choroidal vasculopathy, Intravitreal Bevacizumab

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical CenterRecruiting

Outcomes

Primary Outcome Measures

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

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)

Full Information

First Posted
October 3, 2006
Last Updated
October 3, 2006
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00383812
Brief Title
Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy
Official Title
Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Asan Medical Center

4. Oversight

5. Study Description

Brief Summary
Primary objectives a. To evaluate the Effects of intravitreal Bevacizumab on polypoidal choroidal vasculopathy(PCV) Secondary objectives To assess the changes in visual acuity To assess the change in lesion characteristics of PCV size of PCV fluorescein leakage foveal thickness To investigate the safety of intravitreal Bevacizumab in patients with PCV To assess the effect of intravitreal Bevacizumab on the recurrence rate and the the incidence of submacular hemorrhage in patients with PCV

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypoidal Choroidal Vasculopathy
Keywords
Polypoidal choroidal vasculopathy, Intravitreal Bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Intravitreal Bevacizumab
Primary Outcome Measure Information:
Title
To assess the percentage of patients who gained an improvement in best corrected visual acuity (BCVA) by 15 letters of more.
Title
To assess the percentage of patients whose final visual acuity resulted in Snellen equivalent of 20/200 or worse
Secondary Outcome Measure Information:
Title
To investigate the resolution time of macular edema, subretinal fluid, and/or pigment epithelial detachment (PED) using optical coherence tomography (OCT)
Title
To evaluate change in size and leakage of PCV, using fluorescein angiography (FA) and/or indocyanine angiography (ICGA)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Young Lee, MD
Phone
82-2-3010-3970
Email
sunylee@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Young Hee Yoon, MD
Phone
82-2-3010-3675
Email
yhyoon@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Hee Yoon, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
June-Gone Kim, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sun Young Lee, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyewon Chung, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

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