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Eye study tracks early AMD changes to spot future risks

NCT ID NCT03092492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

26 people

The number who actually took part.

Started

Feb 2018

Finished

Apr 2022

Lead sponsor

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

55 to 120 years

Sex

Anyone

Healthy volunteers

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

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

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.