NCT01233128

Brief Summary

This study is to investigate whether there is an association of the LOC387715/HTRA1 and vascular endothelial growth factor polymorphism with response to treatment with intravitreal ranibizumab injections for patients with polypoidal choroidal vasculopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

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

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 9, 2012

Status Verified

April 1, 2012

Enrollment Period

1.3 years

First QC Date

November 1, 2010

Last Update Submit

April 6, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity

    Best-corrected visual acuity (BCVA) using the Snellen chart was evaluated including BCVA before treatment and BCVA up to 12 months.

    up to 12 months

Secondary Outcomes (1)

  • Angiographic characteristics

    up to 12 months

Study Arms (1)

polypoidal choroidal vasculopathy

patients who were treated for polypoidal choroidal vasculopathy with intravitreal injections of 0.5 mg of ranibizumab monthly for 3 months

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The authors did a retrospective chart review of 70 patients with PCV who visited the Department of Ophthalmology, Kyungpook National University Hospital in Daegu, Korea.

You may qualify if:

  • patients older than 60 years of age at onset
  • polyp-like terminal aneurysmal dilations with or without branching vascular networks in ICGA and subretinal reddish-orange protrusions corresponding to polyp-like lesions
  • patients who had intravitreal injections of 0.5 mg of ranibizumab monthly for 3 months

You may not qualify if:

  • patients with retinal or choroidal diseases including pathologic myopia, angioid streaks, idiopathic choroidal neovascularization (CNV), presumed ocular histoplasmosis, and other secondary CNV
  • patients who refused genotypic analyses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

In Taek Kim

Daegu, Kyungsangpookdo, 700-721, South Korea

Location

Related Publications (1)

  • Immonen I, Seitsonen S, Tommila P, Kangas-Kontio T, Kakko S, Savolainen ER, Savolainen MJ, Liinamaa MJ. Vascular endothelial growth factor gene variation and the response to photodynamic therapy in age-related macular degeneration. Ophthalmology. 2010 Jan;117(1):103-8. doi: 10.1016/j.ophtha.2009.06.037. Epub 2009 Nov 6.

    PMID: 19896188BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Genomic DNA was extracted from peripheral blood with the Qiagen QIAamp Blood Kit (Qiagen, Valencia, CA).

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • In Taek Kim, M.D.

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 3, 2010

Study Start

October 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 9, 2012

Record last verified: 2012-04

Locations