LOC387715/HTRA1 and the Combined Photodynamic Therapy With Intravitreal Bevacizumab in Polypoidal Choroidal Vasculopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01233115
First received: November 1, 2010
Last updated: August 28, 2011
Last verified: August 2011
  Purpose

This study is to investigate whether there is an association of the LOC387715/HTRA1 variants with response to treatment with combined photodynamic therapy and intravitreal bevacizumab for patients with polypoidal choroidal vasculopathy.


Condition
Age-Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: LOC387715/HTRA1 Variants and the Response to Combined Photodynamic Therapy With Intravitreal Bevacizumab in Polypoidal Choroidal Vasculopathy

Resource links provided by NLM:


Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • Best-corrected visual acuity [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Best-corrected visual acuity (BCVA) using the Snellen chart was evaluated including BCVA up to 12 months


Secondary Outcome Measures:
  • Angiographic characteristics [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Fluorescein angiography (FA) and ICGA (HRA; Heidelberg Engineering, Dossenheim, Germany) was evaluated. Greatest linear dimension (GLD) was determined based on both FA and ICGA.


Biospecimen Retention:   Samples With DNA

Genomic DNA was extracted from peripheral blood. The two SNPs (rs10490924 in the LOC387715 locus and rs11200638 in HTRA1 gene) were analyzed by LC480 Real time PCR (Roche, Basel, Switzerland) at D&P Biotech (Daegu, Korea).


Enrollment: 70
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
polypoidal choroidal vasculopathy
patients who were treated for polypoidal choroidal vasculopathy with combined photodynamic therapy and intravitreal bevacizumab injections

Detailed Description:

This is a retrospective cohort study comprised of 70 eyes being treated for polypoidal choroidal vasculopathy with combined photodynamic therapy and intravitreal bevacizumab injections. Patients were genotyped for the LOC387715 (rs10490924) and the HTRA1 gene polymorphism (rs11200638).

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • patients older than 60 years of age at onset
  • polyp-like terminal aneurysmal dilations with or without branching vascular networks in indocyanine green angiography (ICGA) and subretinal reddish-orange protrusions corresponding to polyp-like lesions
  • patients who had combined photodynamic therapy and intravitreal bevacizumab injections, and followed up for more than 12 months after the first treatment

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233115

Locations
Korea, Republic of
In Taek Kim
Daegu, Kyungsangpookdo, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University
Investigators
Principal Investigator: In Taek Kim, M.D. Kyungpook National University
  More Information

Additional Information:
Publications:
Responsible Party: Dong Ho Park, clinical professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01233115     History of Changes
Other Study ID Numbers: LOC387715/HTRA1 & combined PDT
Study First Received: November 1, 2010
Last Updated: August 28, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Macular Degeneration
Vascular Diseases
Retinal Degeneration
Retinal Diseases
Eye Diseases
Cardiovascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014