Actively Recruiting // Age-related Macular Degeneration // Barbara Blodi // Clinical Trials // Jan 28 2019
Age-Related Macular Degeneration Ryan Initiative Study (ARIS)
Sponsor: National Eye Institute
Principal Investigator: Barbara Blodi
Study coordinator: Kris Dietzman
Enhancing the understanding of the natural history of early AMD and RPD.
People ages 55 and older with any of the following:
AMD or changes in the retina that put them at risk for AMD
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.
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)
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
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.
For more information or questions please contact Kris Dietzman 608-263-9035