Advanced Dry Macular Degeneration
Conditions
Keywords
macular degeneration, blindness
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.
Interventions
DEVICEAlpha MSH assay
Assay to detect levels of alpha MSH in intraocular fluid.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of Alpha Melanocyte Stimulating Hormone as Measured by Enzyme-linked Immunosorbent Assay | 2 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Advanced Dry Macular Degeneration Alpha MSH assay: Assay to detect levels of alpha MSH in intraocular fluid. | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Advanced Dry Macular Degeneration |
|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 54 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
Level of Alpha Melanocyte Stimulating Hormone as Measured by Enzyme-linked Immunosorbent Assay
Time frame: 2 hours
Population: Unable to obtain alpha MSH levels.