Genetic Assessment of Early to Late Macular Degeneration Study (GALLEY2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Kang Zhang, MD, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01464710
First received: October 31, 2011
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine if polymorphisms at rs11200638 on HTRA1 and rs1061170 on CFH are associated with an accelerated progression to advanced AMD (wet AMD or GA) in patients with early AMD (soft confluent drusen>120 microns ) in the study eye, and with either early AMD or advanced AMD in the non-study eye.


Condition
Age-related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Assessment of Early to Late macuLar dEgeneration studY 2

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • To determine the allele frequency for patients that progress to bilateral advanced AMD in the study eye [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the allele frequency for patients that do not progress to bilateral advanced AMD in the study eye. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Specimen collected for genotype analysis.


Enrollment: 170
Study Start Date: April 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. To date, two major polymorphisms on the HTRA1 and CFH genes have been associated with AMD. Progression and vision loss need to be followed and treated promptly in order to preserve vision. This study will provide more information on the genetics of disease progression and may lead to future guidelines for patient follow-up and treatment.

This study consists of a blood draw and observation of eye conditions. Consented, enrolled patients will come in every four months as per standard of care. At each visit, visual acuity measurement, slit lamp exam, indirect ophthalmoscopy, fundus photos, and spectral domain optical coherence tomography will be performed. Every 8 months, or per standard of care, fluoroscein angiography will be performed. DNA extraction and genotyping will be performed, and correlations between HTRA1 and CFH genotypes and the progression to bilateral advanced AMD will be analyzed.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with a diagnosis of advanced AMD in one eye (either CNV or geographic atrophy) and soft confluent drusen in the study eye OR subjects with bilateral large soft drusen.

Criteria

Inclusion Criteria:

  • Subjects will be eligible if the following criteria are met:
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 45 years
  • Disease related considerations
  • Subjects with a diagnosis of advanced AMD in one eye (either CNV or geographic atrophy) and soft confluent drusen in the study eye OR subjects with bilateral large soft drusen.

Exclusion Criteria:

  • Subjects with any other progressive retinal disease that may impair the physician's ability to assess the severity of AMD
  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: NCT01464710

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
California Retina Consultants
Santa Barbara, California, United States, 93108
United States, Texas
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
University of California, San Diego
Genentech
Investigators
Principal Investigator: Kang Zhang, MD, PhD UCSD, Shiley Eye Center
  More Information

No publications provided

Responsible Party: Kang Zhang, MD, PhD, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01464710     History of Changes
Other Study ID Numbers: 080585
Study First Received: October 31, 2011
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 26, 2014