Alpha MSH in Ocular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03451578
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 8, 2018
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Dry Macular Degeneration Device: Alpha MSH assay Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Alpha Melanocyte Stimulating Hormone in Ocular Disease
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Advanced Dry macular degeneration Device: Alpha MSH assay
Assay to detect levels of alpha MSH in intraocular fluid.

Primary Outcome Measures :
  1. Level of alpha melanocyte stimulating hormone as measured by enzyme-linked immunosorbent assay [ Time Frame: 2 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03451578

Contact: Latoya Greene 919-684-9072

United States, North Carolina
Duke University Eye Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Latoya Greene    919-684-9072   
Principal Investigator: Sharon Fekrat, MD         
Sponsors and Collaborators
Duke University
Principal Investigator: Sharon Fekrat, MD Duke Eye Center

Responsible Party: Duke University Identifier: NCT03451578     History of Changes
Other Study ID Numbers: Pro00086021
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Duke University:
macular degeneration

Additional relevant MeSH terms:
Retinal Diseases
Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Eye Diseases
Melanocyte-Stimulating Hormones
Adrenocorticotropic Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action