Age-Related Macular Degeneration (ARMD) Clinical Trials

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Progression of Early Atrophic Lesions in Age-related Macular Degeneration (AMD).

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Early atrophic age-related macular degeneration (AMD) represents an important time window in the course of so far untreatable atrophic AMD, as patients typically experience only some degree of visual dysfunction, while being at significant risk for marked further loss of vision. To allow the precise evaluation of upcoming therapeutic interventions, a better understanding of the manifestation and variable disease progression is needed. This project aims to investigate refined tools to detect and monitor early atrophic AMD more accurately, including the impact on visual dysfunction and quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Males and females aged 50 years and older of all ethnicities.

• Prior participation in the University of Utah IRB #00010201, Genetic and Molecular Studies of Eye Disease with written permission to be contacted for further clinical studies.

• Specifically, subjects must carry one or two risk alleles (subjects' nucleotides must be CC or CT to meet eligibility) at the CFH rs1061170 variant (CFH Y402H) or one or two risk alleles (subjects' nucleotides must be GT or TT to meet eligibility) at the ARMS2/HTRA1 rs10490924 variant. This genetic information will be available through the University of Utah IRB #00010201, Genetic and Molecular Studies of Eye Disease.

• Study eye with at least one early atrophic lesion defined as:

• incomplete retinal pigment epithelium (RPE) and outer retinal atrophy (iRORA) (region of signal hypertransmission into the choroid, corresponding zone of attenuation or disruption of the RPE, and evidence of overlying photoreceptor degeneration that is, subsidence of the inner nuclear layer (INL) and outer plexiform layer (OPL), presence of a hyporeflective wedge in the Henle fiber layer (HFL), thinning of the outer nuclear layer (ONL), disruption of the external limiting membrane (ELM), or disintegrity of the ellipsoid zone (EZ), or

• complete RPE and outer retinal atrophy (cRORA) (homogeneous choroidal hypertransmission, absence of the RPE band measuring \> 250µm, evidence of overlying photoreceptor degeneration) and total lesions size =\< ½ disc area (DA) (corresponding to 1.27mm2 area) of all atrophic lesions measured on fundus-autofluorescence (FAF) imaging in the study eye.

• Sufficiently clear ocular media, adequate pupillary dilatation, and adequate fixation to permit quality fundus imaging and unbiased functional testing incl. fundus-controlled perimetry (FCP) testing.

• Ability to comply with study protocol timelines.

Locations
United States
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Ray Nelson
Ray.Nelson@hsc.utah.edu
801 585 1890
Backup
Karen Daynes
Karen.Daynes@hsc.utah.edu
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 125
Treatments
Early GA lesions
Non-interventional
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: University of Utah
Collaborators: National Eye Institute (NEI)

This content was sourced from clinicaltrials.gov

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