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