Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

Not Applicable

• Conditions: Polypoidal Choroidal Vasculopathy

• Registration Number: NCT00383812
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Status Verified: 2006-10
• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-03
• Last Update Submitted: 2006-10-03
• Study First Posted: 2006-10-04
• Last Update Posted: 2006-10-04
• Study Completion: 2008-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of