Genetic Assessment of Early to Late Macular Degeneration Study

Genetic Assessment of Early to Late macuLar dEgeneration studY 2

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01464710

Acronym

GALLEY2

Enrollment

170

Registered

2011-11-03

Start date

2008-04-30

Completion date

2015-01-31

Last updated

2019-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine the allele frequency for patients that progress to bilateral advanced AMD in the study eye	5 years

Secondary

Measure	Time frame
To determine the allele frequency for patients that do not progress to bilateral advanced AMD in the study eye.	5 years

Countries

United States

Outcome results