Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

Polypoidal Choroidal Vasculopathy Clinical Trial

Official title:

Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00383812
• Other study ID #: Bevacizumab for PCV
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2006
• Last updated: October 3, 2006
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: October 2006
• Source: Asan Medical Center
• Contact: Sun Young Lee, MD
• Phone: 82-2-3010-3970
• Email: sunylee[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Drug:
• Intravitreal Bevacizumab

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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