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Alpha MSH in Ocular Disease

NCT ID: NCT03451578

Last Updated: 2022-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-06

Study Completion Date

2021-10-19

Brief Summary

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The purpose of this study is gain a better understanding of a molecule called alpha melanocyte stimulating hormone (alpha MSH) and its potential role in your retinal disease. Alpha MSH has been shown to have an important role in the regulation of ocular immunity in animal models of inflammatory retinal diseases and retinal dystrophies, and there may be a protective effect of alpha MSH. By studying the levels of alpha MSH in your eye we may better understand its role in advanced dry macular degeneration. By studying the levels of this molecule we hope to better understand if it may be a good target for future treatment.

Detailed Description

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A small amount (0.1 mL) of aqueous humor would be removed from the study eye in the clinic setting. This sample will be processed and then sent off for measurement of alpha MSH levels.

Conditions

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Advanced Dry Macular Degeneration

Keywords

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macular degeneration blindness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Advanced Dry macular degeneration

Group Type OTHER

Alpha MSH assay

Intervention Type DEVICE

Assay to detect levels of alpha MSH in intraocular fluid.

Interventions

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Alpha MSH assay

Assay to detect levels of alpha MSH in intraocular fluid.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 60 years or older
* diagnosis of advanced dry macular degeneration with foveal geographic atrophy
* limited vision or blindness (20/100 or worse) in that eye
* pseudophakia (prior cataract surgery in that eye)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon Fekrat, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Eye Center

Locations

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Duke University Eye Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Pro00086021

Identifier Type: -

Identifier Source: org_study_id