Back to resultsAlpha MSH in Ocular Disease
Primary Purpose
Advanced Dry Macular Degeneration
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alpha MSH assay
Sponsored by
About this trial
This is an interventional diagnostic trial for Advanced Dry Macular Degeneration focused on measuring macular degeneration, blindness
Eligibility Criteria
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:
Sites / Locations
- Duke University Eye Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Advanced Dry macular degeneration
Arm Description
Outcomes
Primary Outcome Measures
Level of Alpha Melanocyte Stimulating Hormone as Measured by Enzyme-linked Immunosorbent Assay
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03451578
Brief Title
Alpha MSH in Ocular Disease
Official Title
The Role of Alpha Melanocyte Stimulating Hormone in Ocular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
October 19, 2021 (Actual)
Study Completion Date
October 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Dry Macular Degeneration
Keywords
macular degeneration, blindness
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Advanced Dry macular degeneration
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Alpha MSH assay
Intervention Description
Assay to detect levels of alpha MSH in intraocular fluid.
Primary Outcome Measure Information:
Title
Level of Alpha Melanocyte Stimulating Hormone as Measured by Enzyme-linked Immunosorbent Assay
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Fekrat, MD
Organizational Affiliation
Duke Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Alpha MSH in Ocular Disease
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