AMD Ryan Initiative Study (ARIS)

Age-Related Macular Degeneration Clinical Trial

Official title: AMD Ryan Initiative Study

Status Completed

Clinical Trial 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.

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Clinical Trial Description

Objective:

Late age-related macular degeneration (AMD) is the leading cause of blindness among elderly in the United States. At present, the current classification systems do not take into consideration advances in imaging technology, visual function biomarkers, as well as genotyping and phenotyping.

Clinical sites in the United States and around the world will conduct a longitudinal study that will bring together resources and commitment for the development of a classification scheme for AMD using imaging and visual function biomarkers, with the plan to correlate genetic information obtained in the future. These data could eventually help develop an understanding of the mechanisms involved in the development and progression of AMD. The project will recruit participants with early AMD or reticular pseudodrusen (RPD) and controls. All data and images from this longitudinal study will be available to researchers worldwide to help in the development of visual function biomarker identification and classification development. The initiative should provide an unparalleled state-of-the-art standardized phenotype and genotype including AMD status with information on imaging, visual function and biomarkers, with a particular focus to developing surrogate outcome variables for proof of principle phase 2 clinical trials.

Study Population:

This cohort study will recruit up to 500 total participants with early AMD or RPD, including age-matched controls.

Design:

This study is designed as a multi-center, international, prospective, observational cohort study of participants with early AMD or RPD. Study participants will undergo clinical assessments, multi-modal imaging and receive the standard of care as determined by the participant s ophthalmologist.

Outcome Measures:

Further research is necessary to characterize RPD and to understand the progression of AMD from early to late stage disease. The primary objectives of the longitudinal observational study are to enroll participants with early AMD (medium size drusen) to assess rate of change in drusen volume and progression rates to large drusen, and associate these morphologic changes with psychophysical changes, including visual acuity and dark adaptation. Separately, participants with RPD (verified by Reading Center review) will be enrolled and followed to better understand the natural history of RPD as well as to document structural and functional changes over time and associate them with the psychophysical changes listed above and changes in quality of life. In addition, control participants with no drusen or little drusen (normal aging changes) will be enrolled as comparison groups for the early AMD and reticular drusen groups. Data from this study will be analyzed to identify potential risk factors for disease progression and possible outcome variables for future studies. The collection of multi-model imaging at baseline and longitudinally will allow for an assessment of the disease classification and morphologic changes that might serve as biomarkers for disease progression for eyes with early AMD or RPD. Psychophysical testing will help assess functional changes and associations. Information will be disseminated to help the ophthalmic community better understand the natural course of early AMD and RPD.

To meet these objectives, the study will encourage up to approximately 20 sites participating in the AMD Ryan Initiative Study (ARIS) to recruit and characterize patients with early AMD or RPD for the longitudinal study.

The longitudinal phase of ARIS will collect information on consenting participants with early AMD or RPD seen at participating sites. Routine data collection will focus on the following:

• Enhancing the understanding of the natural history of early AMD and RPD

• Evaluating the functional characteristics of early AMD and RPD

• Compiling information on the potential ocular associations and natural progression of RPD

• Evaluating risk factors for disease progression in participants with early AMD and RPD

• Evaluating multi-model imaging to understand the mechanisms involved in the pathogenesis of early AMD and RPD

• Determining the 5-year progression rate to large drusen or late AMD in eyes with early AMD or RPD (in those participants who have NO large drusen at baseline)

• Determining the rate of change in drusen volume in eyes with early AMD and possibly the rate of change in the volume of sub-retinal deposits in eyes with RPD, stratified by the presence or absence of large drusen

• Compare the rates of progression in RPD in eyes with and without early or intermediate AMD

• Developing possible surrogate outcome variables associated with progression to late AMD or visual acuity loss including change in drusen volume

• Improving classification criteria for RPD ;

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

• NCT number: NCT03092492
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Start date: February 12, 2018
• Completion date: November 7, 2022