Alpha MSH in Ocular Disease

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT03451578
Collaborator
(none)
54
1
1
43.5
1.2

Study Details

Study Description

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
  • Device: Alpha MSH assay
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
N/A
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 :
Mar 6, 2018
Actual Primary Completion Date :
Oct 19, 2021
Actual Study Completion Date :
Oct 19, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Advanced Dry macular degeneration

Device: Alpha MSH assay
Assay to detect levels of alpha MSH in intraocular fluid.

Outcome Measures

Primary Outcome Measures

  1. Level of alpha melanocyte stimulating hormone as measured by enzyme-linked immunosorbent assay [2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Eye Center Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Sharon Fekrat, MD, Duke Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03451578
Other Study ID Numbers:
  • Pro00086021
First Posted:
Mar 1, 2018
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2022