ClinicalTrials.gg
CompletedNCT03451578Updated Dec 22, 2022Results posted

Alpha MSH in Ocular Disease

An interventional study of Alpha MSH assay in Advanced Dry Macular Degeneration, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-22.

Sponsored by Duke University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Advanced Dry Macular Degeneration

Keywords

  • macular degeneration
  • blindness
03

In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's enrollment of 54 is close to the median of 56 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
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

Exclusion Criteria:

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Other
    Advanced Dry macular degeneration

    Device: Alpha MSH assay

Interventions

  • DeviceAlpha MSH assay

    Assay to detect levels of alpha MSH in intraocular fluid.

06

What researchers measure

Primary outcomes

  1. Level of Alpha Melanocyte Stimulating Hormone as Measured by Enzyme-linked Immunosorbent Assay

    Time frame: 2 hours

07

Results

Posted Dec 22, 2022
Limitations and caveats
The investigators found through various approaches that alpha MSH was not measurable within the samples.

Participant flow

Participant flow — Overall Study
MilestoneAdvanced Dry Macular Degeneration
Started54
Completed54
Not completed0

Outcome measures

PrimaryLevel of Alpha Melanocyte Stimulating Hormone as Measured by Enzyme-linked Immunosorbent Assay
Time frame:
2 hours

No measurements were reported for this outcome.

Adverse events

Collected over 1 visit, up to 2 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Advanced Dry Macular Degeneration0/54 (0%)0/54 (0%)0/54 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Advanced Dry Macular Degeneration
Mean67.9 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)Advanced Dry Macular Degeneration
Female34
Male20
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Advanced Dry Macular Degeneration
Hispanic or Latino0
Not Hispanic or Latino52
Unknown or Not Reported2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Advanced Dry Macular Degeneration
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American5
White45
More than one race0
Unknown or Not Reported2
Region of Enrollment
Region of Enrollment(Participants)Advanced Dry Macular Degeneration
United States54
08

Study locations

1 site
  • Duke University Eye Center
    Durham, North Carolina 27710, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03451578
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Mar 1, 2018
Start date
Mar 6, 2018
Primary completion
Oct 19, 2021
Completion
Oct 19, 2021
Results posted
Dec 22, 2022
Last update
Dec 22, 2022

Study contacts

Sharon Fekrat, MD
principal investigator · Duke Eye Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion