AMD Ryan Initiative Study (ARIS)

NCT03092492 | Completed

• 2 other identifiers: 17007117-EI-0071
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To learn more about AMD. Eligibility: People ages 55 and older with any of the following: Early AMD RPD Healthy eyes Design: Participants will be screened with: Eye exam: The pupil will be dilated with eye drops. Eye pressure and movements will be checked. Pictures will be taken of the inside of the eye. Reading an eye chart. Optical coherence tomography (OCT): The eyes are dilated. A machine measures the thickness of the retina. Participants will have a first visit that includes: Repeat of screening procedures Medical history Physical exam Questions about vision and general health Dark adapted fundus perimetry: Participants sit in the dark for 40 minutes. Then they sit at a machine that shines lights in the eyes. Dark adaption testing: Participants sit in the dark for 45 minutes. The pupils are dilated. They push a button when they see light in a machine for up to 1 hour. Participants will have annual visits for up to 5 years to repeat the tests in the first visit. Participant data may be shared for other research....

Conditions

Age-Related Macular Degeneration

Keywords

Age Related Macular Degeneration; Age-Related Macular Degeneration (AMD); Reticular Pseudodrusen; Natural History

Outcome Measures

Primary Outcomes (3)

• Enroll participants with early AMD (medium size drusen) to assess rate of change in drusen volume and progression rates to large drusen, and associate these morphologic changes with psychophysical changes, including visual acuity and dark adapta...

  The collection of multi-model imaging at baseline and longitudinally will allow for an assessment of the disease classification and morphologic changes that might serve as biomarkers for disease progression foreyes with early AMD or RPD. Psychophysical testing will help assess functional changes and associations.

  5 years

• Better understand the natural history of RPD as well as to document structural and functional changes over time and associate them with psychophysical changes and changes in quality of life.

  The collection of multi-model imaging at baseline and longitudinally will allow for an assessment of the disease classification and morphologic changes that might serve as biomarkers for disease progression foreyes with early AMD or RPD. Psychophysical testing will help assess functional changes and associations.

  5 years

• Identify potential risk factors for disease progression and possible outcome variables for future studies

  Data from this study will be analyzed to identify potential risk factors for disease progression and possible outcome variables for future studies. Information will be disseminated to help the ophthalmic community better understand the natural course of early AMD and RPD

  5 years

Study Arms (4)

Cohort 1

Participants with bilateral early AMD and medium drusen in both eyes

Cohort 2A

Participants with at least one eye with RPD , with small or medium-sized drusen in either eye

Cohort 2B

Participants with at least 1 eye with RPD, with large drusen in either eye

Cohort 3

Healthy age-matched controls

Eligibility Criteria

• Age: 55 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants at the NIH site will be recruited from the current patient population in our eye clinic as well as from new referrals from area clinics and practices.

You may qualify if:

• To participate in the longitudinal study, the potential participant must meet all of the following criteria.
• Men and women aged 55 and older;
• Clinical and Reading Center verification:
• Cohort 1 - Early AMD, N=200 (Medium drusen \>=63mu and \<125mu) OU
• Cohort 2 - RPD, N=200, (2A)At least one eye with RPD with no large drusen (\>=125mu) in either eye; (2B)At least one eye with RPD with \>=1 large drusen (\>=125mu) in either eye (n=100)
• Cohort 3 - Controls, N=100, No medium or large drusen, no peripheral drusen, no RPD or pigmentary changes OU
• Best Corrected Visual Acuity of 20/25 or better;
• Previous ocular surgeries allowed include cataract surgery more than three months prior to enrollment in ARIS and peripheral laser, cryotherapy for peripheral tears;
• Participant must be able to review and understand the informed consent form, agree to the contents and be able to sign the informed consent.

You may not qualify if:

• Any evidence of late AMD (i.e. CNV or GA) in either eye.
• Ocular disease other than AMD in either eye, in the Investigator's opinion, which may confound assessment of the retina including:
• Amblyopia (in study eye only for Cohort 2)
• Angioid streaks
• Choroidal nevus within 2 DD of the center of the macula associated with depigmentation or overlying atypical drusen
• Epiretinal membrane of significant size located in the macular area that potentially can cause vision loss
• Myopic crescent of the optic disc the width of which is greater than or equal to 50% of the longest diameter of the disc, or pigmentary abnormalities in the posterior pole considered by the clinic ophthalmologist more likely to be due to myopia than to AMD
• Central Serous Choroidopathy
• Optic Atrophy
• Diabetic retinopathy unless retinopathy is limited to fewer than 10 microaneurysms and/or small retinal hemorrhages
• Macular hole or pseudohole
• Pigmentary abnormalities considered by the Clinical Site ophthalmologist to be less typical of AMD than of some other condition, such as pattern dystrophy or chronic central serous retinopathy
• Retinal vein occlusion, active uveitis, presumed ocular histoplasmosis syndrome, other sight-threatening retinopathies, and other retinal degenerations, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration
• 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;
• 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:

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Emily Y Chew, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: February 12, 2018
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: April 1, 2026

Record last verified: 2025-10-23

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)