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Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00383812
First received: October 3, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

  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 Intervention
Polypoidal Choroidal Vasculopathy
 Drug: Intravitreal Bevacizumab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

Resource links provided by NLM:

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

Further study details as provided by Asan Medical Center:

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)

Estimated Enrollment: 20
Study Start Date: May 2006
Estimated Study Completion Date: May 2008
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00383812     History of Changes
Other Study ID Numbers: Bevacizumab for PCV
Study First Received: October 3, 2006
Last Updated: October 3, 2006
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
 Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013