NCT01271426

Brief Summary

To determine whether complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2) genotypes have a pharmacogenetic effect on the treatment of polypoidal choroidal vasculopathy (PCV) with ranibizumab.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
Last Updated

January 6, 2011

Status Verified

January 1, 2011

Enrollment Period

1.9 years

First QC Date

January 5, 2011

Last Update Submit

January 5, 2011

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

Polypoidal Choroidal VasculopathyRanibizumab

Outcome Measures

Primary Outcomes (1)

  • Association of Complement Factor H and ARMS2 Genotypes with Response of Polypoidal Choroidal Vasuculopathy to Intravitral Ranibizumab

    a month after injection

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

outpatients in hospital

You may qualify if:

  • Clinical diagnosis of Polypoidal choroidal vasculopathy
  • must have injection of Ranibizumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surugadai Nihon university hospital

1-8-13 Kandasurugadai Chiyoda-ku, Tokyo, 101-8309, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

white blood cell

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 6, 2011

Study Start

April 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

January 6, 2011

Record last verified: 2011-01

Locations

JP(1)