CClinicalTrials.gg
CompletedNCT01464710GALLEY2Updated Jun 21, 2019

Genetic Assessment of Early to Late Macular Degeneration Study

An observational study in Age-related Macular Degeneration, sponsored by Henry Ferreyra. Completed at 3 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2019-06-21.

Sponsored by Henry Ferreyra · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
170
Ages
45 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Age-related Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 170 is above the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

This is the only study on the registry with Henry Ferreyra as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Subjects with any other progressive retinal disease that may impair the physician's ability to assess the severity of AMD
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
170 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

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

07

Study locations

3 sites
  • University of California, San Diego
    La Jolla, California 92093, United States
  • California Retina Consultants
    Santa Barbara, California 93108, United States
  • Medical Center Ophthalmology Associates
    San Antonio, Texas 78240, United States
08

References and documents

Individual participant data

Plan to share: No — Data not available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01464710
Lead sponsor
Henry Ferreyra
Collaborators
Genentech, Inc.
Responsible party
Henry Ferreyra (Principal Investigator, University of California, San Diego) — Sponsor-investigator
First posted
Nov 3, 2011
Start date
Apr 2008
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Jun 21, 2019

Study contacts

Henry Ferreyra, M.D
study chair · University of California, San Diego

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion