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AMD Ryan Initiative Study (ARIS) - Longitudinal Study of Early AMD and Reticular Pseudodrusen

Primary Objective

The primary purpose of this study is to gather patient information for a large database to better understand and classify the changes that predict progression to vision loss in age-related macular degeneration (AMD).

Study category: Eyes

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Description

The goal of this project is to better understand the natural history and characteristics of early AMD. Another goal is to determine the course of the progression to intermediate and/or advanced AMD in eyes with early AMD and a certain finding associated with early AMD (Reticular Pseudodrusen).

Main Procedures Involved: Screening Visit: You will be asked about your age, race, ethnicity, and contact information. The procedures you may complete at this visit are: 1. Eye Examination 2. Visual Acuity Test 3. Optical Coherence Tomography (OCT) 4. Fundus Photography, Infrared (IR) Reflectance and Fundus Autofluorescence Baseline Visit (may be combined with Screening Visit): Medication History (and any treatments you’ve had for AMD in the past) Medical History Ocular Medical History Social History Measure your blood pressure, height and weight. National Eye Institute’s Visual Functioning Questionnaire (NEI-VFQ) At selected sites, AdaptDx may be performed on one of your eyes. Follow-up Visits Ask about updates to your medications, medical, ocular and social history Visual Questionnaire Visual Acuity OCT Fundus Autofluorescence IR reflectance Fundus Photographs Complete examination of your eyes *If you have reticular drusen and are in Group 2, the NEI-VFQ questionnaire will be conducted again at Month 36 and for all participants at Month 60. *At selected sites, dark adapted fundus perimetry and dark adaptation (AdaptDx) may be performed on the same eye at each visit based on your birth month.

Duration of Participation: First, you will complete a screening visit. Then, if you’re found to be eligible, you will complete a baseline visit within four months. In some cases, the screening and baseline visits may be combined. Next, you will attend annual visits at Months 12, 24, 36, 48 and 60. If you are eligible, participation in this study will last up to five years.

Details
Age

55 to 100 years

Eligibility

In order to qualify for this study, you must have been diagnosed with early age-related macular degeneration and fit certain criteria that will be assessed at a screening visit.

Type of Study

Observational

Location

University of Colorado Hospital

Principal Investigator
Naresh Mandava,  MD

Naresh Mandava, MD

Study ID

Protocol Number: 18-0520

More information available at ClinicalTrials.gov: NCT03092492

Categories

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