Eye study tracks early AMD changes to spot future risks
NCT ID NCT03092492
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 7 times
Summary
This completed study followed 26 adults aged 55 and older with early age-related macular degeneration (AMD) or healthy eyes for up to 5 years. Researchers used eye exams, imaging, and vision tests to track changes in the retina and visual function. The goal was to better understand how early AMD progresses and to identify potential markers for future disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help identify early signs and risk factors for AMD progression, guiding future research and monitoring strategies.
- What could go wrong
- This is an observational study, not a treatment trial. It cannot directly lead to a cure or therapy, and findings may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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26 people
The number who actually took part.
- Started
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Feb 2018
- Finished
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Apr 2022
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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55 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: A participant is not eligible if any of the following exclusion criteria are present. * 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: 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. * Retinal laser treatments and cryosurgery for retinal tears is not an exclusion. * 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); * Participants with confirmed glaucoma (visual field and/or disc/nerve fiber layer defects); * 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. * Participant has photographically significant corneal or media opacities; * 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; * Participant is medically unable to comply with study procedures or follow-up visits. * Participation in research study involving treatment for AMD.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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