Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy - Full Text View

Sponsored by:	Asan Medical Center
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00383812

Purpose

Primary objectives

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

Drug Information available for: Bevacizumab

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

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

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

Sponsors and Collaborators

Asan Medical Center

Investigators

More Information

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

Keywords provided by Asan Medical Center:

Polypoidal choroidal vasculopathy
Intravitreal Bevacizumab

Study placed in the following topic categories:

Bevacizumab

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009