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Completed

NCT Number: NCT01464710

Genetic Assessment of Early to Late Macular Degeneration Study

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Diego, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To determine the allele frequency for patients that progress to bilateral advanced AMD in the study eye

    Time frame: 5 years

Secondary outcomes

  1. To determine the allele frequency for patients that do not progress to bilateral advanced AMD in the study eye.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Henry Ferreyra

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Genetic Assessment of Early to Late macuLar dEgeneration studY 2

Acronym: GALLEY2

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Nov 3, 2011
Registry last updated
Jun 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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