Advanced Dry Macular DegenerationNCT03451578
Alpha MSH in Ocular Disease
A study testing Alpha MSH assay in people with Advanced Dry Macular Degeneration, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Dry Macular Degeneration
- What is being tested?
- Alpha MSH assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 19 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Eye Center
Durham, North Carolina, 27710
About this study
Official title: The Role of Alpha Melanocyte Stimulating Hormone in Ocular Disease
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.
- Conditions
- Advanced Dry Macular Degeneration
- Being tested
- Alpha MSH assay
- Keywords
- macular degeneration, blindness
- Medical subject headings
- Macular Degeneration, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha MSH assayDevice
Assay to detect levels of alpha MSH in intraocular fluid.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Dry macular degeneration | Other | Not described Receives: Device: Alpha MSH assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Alpha Melanocyte Stimulating Hormone as Measured by Enzyme-linked Immunosorbent Assay
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start6 Mar 2018
- Primary completion19 Oct 2021
- Study completion19 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Dry Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Fekrat, MD, Principal investigator, Duke Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451578
- Sponsor's protocol ID
- Pro00086021
- Status last verified
- Dec 2022
- First submitted
- 26 Feb 2018
- Last updated
- 22 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Alpha Melanocyte Stimulating Hormone in Ocular Disease
- ClinicalTrials.gov ID
- NCT03451578
- Acronym / sponsor ID
- Pro00086021
- Conditions
- Advanced Dry Macular Degeneration
- Keywords
- macular degeneration, blindness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Posted 22 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Dry macular degeneration | Other | Device: Alpha MSH assay |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha MSH assayAssay to detect levels of alpha MSH in intraocular fluid. | Device | Advanced Dry macular degeneration |
Primary outcome
Level of Alpha Melanocyte Stimulating Hormone as Measured by Enzyme-linked Immunosorbent Assay
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Fekrat, MD principal investigator
Duke Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha MSH assay in people with Advanced Dry Macular Degeneration, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Alpha Melanocyte Stimulating Hormone as Measured by Enzyme-linked Immunosorbent Assay (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.