NCT00383812

Brief Summary

  • size of PCV
  • fluorescein leakage
  • foveal thickness
  • To investigate the safety of intravitreal Bevacizumab in patients with PCV
  • To assess the effect of intravitreal Bevacizumab on the recurrence rate and the the incidence of submacular hemorrhage in patients with PCV

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 4, 2006

Status Verified

October 1, 2006

First QC Date

October 3, 2006

Last Update Submit

October 3, 2006

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

Polypoidal choroidal vasculopathyIntravitreal Bevacizumab

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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)

Interventions

Intravitreal BevacizumabDRUG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Condition Hierarchy (Ancestors)

Choroidal NeovascularizationChoroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Young Lee, MD

CONTACT

82-2-3010-3970sunylee@amc.seoul.kr

Young Hee Yoon, MD

CONTACT

82-2-3010-3675yhyoon@amc.seoul.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2006

First Posted

October 4, 2006

Study Start

May 1, 2006

Study Completion

May 1, 2008

Last Updated

October 4, 2006

Record last verified: 2006-10

Locations

KR(1)