ARIS

Actively Recruiting // Age-related Macular Degeneration // Barbara Blodi // Clinical Trials // Geographic Atrophy // Jan 28 2019

Age-Related Macular Degeneration Ryan Initiative Study (ARIS)

  • Sponsor: National Eye Institute
  • Principal Investigator: ¬†Barbara Blodi, MD
  • Study coordinator: Kris Dietzman

Study objective:

To understand the progression of age-related macular degeneration from early to late-stage disease

Study design:

Subjects will have annual study visits for up to 5 years. During study visits subjects will undergo clinical assessments, multi-modal imaging and receive the standard of care as determined by their ophthalmologist.

Inclusion criteria:

  • 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, (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 drusen >63mu, no RPD or pigmentary changes OU
  • Best Corrected Visual Acuity of 20/25 or better

Exclusion criteria:

  • Any evidence of late AMD (i.e. CNV or GA) in either eye
  • 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
  • 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.

Contact Kris Dietzman with questions: 608-263-9035. For more information about this study: visit clinicaltrials.gov