A Study of Age-Related Macular Degeneration (vision loss) and Reticular Pseudodrusen (yellow pattern in the vision part of eye)

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Age: 55 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Age-related macular degeneration, AMD, vision loss
Type: Other Study
Target:
25 Participants
Investigator:
Description
Age-related macular degeneration (AMD) is a disease that causes blurred vision. It blurs the sharp, central vision you need for “straightahead” activities such as reading, sewing, and driving. AMD affects the macula, the part of the eye that allows you to see fine detail. The macula is located in the center of the retina, the light-sensitive tissue at the back of the eye.

The most common early sign that a person is at risk for AMD is tiny yellowish spots beneath the retina called drusen. Drusen can be seen by your doctor and on images of your eyes. Most people over the age of 60 have a few small drusen and these are considered normal aging changes. The development of large drusen indicates
that you are at risk for developing vision loss from AMD even though your vision may still be nearly normal.

Reticular pseudodrusen (RPD) is a yellowish pattern that can appear in the macular area. It has been associated with an increased risk of developing vision loss. The late stages of RPD are similar to late AMD.

The study doctors want to find out what AMD looks like inside the eyes of patients with the disease (phenotype) compared to patients without AMD. This may help doctors one day identify which genes may cause the disease (genotype). Your phenotype consists of the observable, physical characteristics. Your genotype is the genetic trait or traits found within your DNA.

The goal of this project is to better understand the natural history and characteristics of early AMD and RPD.

Another goal is to determine the course of the progression to intermediate and/or advanced AMD in eyes with early AMD or RPD. In addition, the study will be evaluating the presence of any risk factors for disease progression in participants with RPD.

The study will gather patient information to create a large database. The database will be used to document changes in the eye over time and classify the changes that predict progression to vision loss in AMD. Investigators hope to possibly apply these findings to discover potential treatments for AMD.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion Criteria:

  1. Men and women aged 55 and older;

  2. Clinical and Reading Center verification:

  3. Best Corrected Visual Acuity of 20/25 or better; Cohort 1 – Early AMD: Medium drusen (>63µ and ≤125µ) OU Cohort 2 – RPD: At least one eye with RPD with no more than 1 large drusen (>125µ) in either eye. Cohort 3 – Controls: No medium or large drusen >63µ, no peripheral drusen, no RPD, or pigmentary

  4. Previous ocular surgeries allowed include cataract surgery more than 3 months prior to enrollment in ARIS and peripheral laser, cryotherapy for peripheral tears;

  5. Participant must be able to review and understand the informed consent form, agree to the contents and sign the informed consent

Exclusion Criteria:

  1. Any evidence of CNV or GA in either eye;

  2. Ocular disease other than AMD in either eye, in the Investigator’s opinion, which may confound assessment of the retina including

  3. Previous retinal or other ocular surgical procedures, the effects of which may now or in the future complicate assessment of the progression of AMD in the Investigator’s opinion; a. These surgeries can be divided into those for 1) glaucoma: argon laser trabeculoplasty, trabeculectomy, and other penetrating glaucoma surgery involving valves, etc., 2) retinal diseases: laser photocoagulation (except to repair a peripheral retinal hole), cryosurgery (except any procedure to repair a peripheral retinal hole), intravitreal injections, vitrectomy 3) Refractive surgery: Lasik, peripheral radial keratotomy (PRK), KAMRATM (corneal inlay for correction of presbyopia), 4) corneal diseases: lamellar keratoplasty, penetrating keratoplasty (PKP), Descement Membrane Endothelial Keratoplasty (DMEK), Descemet Stripping Endothelial Keratoplasty (DSEK), DSEK-A (DSEK-automated), Ultra-thin DESK, Deep Anterior lamellar Keratoplasty (DALK), 5) pterygium surgery that affects or threatens the visual axis, Others) radiation for ocular tumor, repair of corneal or sclera laceration. b. Retinal laser treatments and cryosurgery for retinal tears is not an exclusion.

  4. Any other ocular condition requiring long-term therapy or surgery during the study or any other retinal pathology that in the Investigator’s opinion will interfere with the interpretation of the macular AMD findings (e.g., CRVO);

  5. Participants with confirmed glaucoma (visual field and/or disc/nerve fiber layer defects); a. Participants with a current IOP > 26, a history of the diagnosis of increased intraocular pressure, glaucoma, past or present use of medications to control intraocular pressure, or disc/nerve fiber layer defects suggestive of glaucoma can be eligible if the absence of a glaucomatous visual field defect can be documented by a normal Goldmann, Humphrey or Octopus perimetry test within six months prior to qualification.

  6. Participant has photographically significant corneal or media opacities;

  7. Participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments;

  8. Participant is medically unable to comply with study procedures or follow-up visits.

  9. Participation in a research study involving treatment for AMD.

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
Participants will be in this study approximately 5 years and visit the research site approximately 7 times.
Recruitment period
From May 2, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Denise Macias
Research Topic
Conditions:
  • Age- Related Macular Degeneration

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