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AMD Ryan Initiative Study (ARIS)

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ClinicalTrials.gov Identifier: NCT03092492
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Brief Summary:

Objective:

To learn more about AMD.

Eligibility:

People ages 55 and older with any of the following:

AMD or changes in the retina that put them at risk for 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.


Condition or disease
Age- Related Macular Degeneration

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AMD Ryan Initiative Study (ARIS)
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
1
Late age-related macular degeneration (AMD)
2
early reticular pseudodrusen (RPD)
3
control group



Primary Outcome Measures :
  1. Enhancing the understanding of the natural history of early AMD and RPD. [ Time Frame: Ongoing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This cohort study will recruit a minimum of 500 total participants with early AMD or RPD, including age-matched controls.
Criteria
  • INCLUSION CRITERIA:

To participate in the longitudinal study, the potential participant must meet all of the following criteria. These criteria are bilateral for all participants except those with unilateral RPD.

  • Men and women aged 55 and older;
  • Clinical and Reading Center verification:

    • Cohort 1 - Early AMD, N=200 (Medium drusen >63mu and less than or equal to 125mu) OU
    • Cohort 2 - RPD, N=200, At least one eye with RPD with no more than 1 large drusen (>125mu) in either eye
    • Cohort 3 - Controls, N=100, No drusen >63mu, 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092492


Contacts
Contact: Angel H Garced, R.N. (301) 594-3141 garceda@nei.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
Principal Investigator: Emily Y Chew, M.D. National Eye Institute (NEI)

Additional Information:
Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT03092492     History of Changes
Other Study ID Numbers: 170071
17-EI-0071
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 3, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Age Related Macular Degeneration
Age Related Macular Degeneration (AMD)
Reticular Pseudodrusen

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases