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Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

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ClinicalTrials.gov Identifier: NCT00383812
Recruitment Status : Unknown
Verified October 2006 by Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : October 4, 2006
Last Update Posted : October 4, 2006
Sponsor:
Information provided by:
Asan Medical Center

Brief Summary:
  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

Condition or disease Intervention/treatment
Polypoidal Choroidal Vasculopathy Drug: Intravitreal Bevacizumab

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy
Study Start Date : May 2006
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383812


Contacts
Contact: Sun Young Lee, MD 82-2-3010-3970 sunylee@amc.seoul.kr
Contact: Young Hee Yoon, MD 82-2-3010-3675 yhyoon@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Young Hee Yoon, MD Asan Medical Center
Principal Investigator: June-Gone Kim, MD Asan Medical Center
Principal Investigator: Sun Young Lee, MD Asan Medical Center
Principal Investigator: Hyewon Chung, MD Asan Medical Center

ClinicalTrials.gov Identifier: NCT00383812     History of Changes
Other Study ID Numbers: Bevacizumab for PCV
First Posted: October 4, 2006    Key Record Dates
Last Update Posted: October 4, 2006
Last Verified: October 2006

Keywords provided by Asan Medical Center:
Polypoidal choroidal vasculopathy
Intravitreal Bevacizumab

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents