- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02151318
Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies
June 24, 2024 updated by: University of South Florida
In this study, the investigators will collect tissue from patients undergoing trabeculectomy for primary open-angle glaucoma treatment.
This tissue would normally be discarded.
These trabecular meshwork (TM) cells can be cultured and used experimentally to better understand the mechanisms of glaucoma.
These TM biopsies will be cultured on the same day as the trabeculectomy using established techniques.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Tampa, Florida, United States, 33606
- Tampa General Hosipital
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Tampa, Florida, United States, 33613
- Byrd Alzheimer's Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients having glaucoma and undergoing a trabeculotomy
Description
Inclusion Criteria:
- Patients having glaucoma and undergoing a trabeculotomy
- Sign ICF (Informed Consent Form)
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of new glaucoma medications to reduce TM cellular pathologies associated with the disease glaucoma.
Time Frame: 6 weeks
|
TM cell biopsy samples from patients with glaucoma will be harvested and cultured in a laboratory setting to grow primary human TM cells.
These cells will be used to test different medications, looking at the medications ability to reduce cellular pathologies commonly seen in TM tissue of patients with glaucoma.
Pathologies include myocilin aggregation, and cell death.
This will help researchers to determine the most effective compounds in treating glaucoma.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cultured TM cell toxicity caused by new glaucoma medications
Time Frame: 6 weeks
|
Cultured primary TM cells treated with various new medications synthesized to treat cellular pathologies associated with glaucoma, will also be analyzed to look at toxicity caused by the treatments themselves.
THis will help to determine the safety of these new medications prior to being administered to patients.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chad A Dickey, PhD, University of South Florida department of Molecular Medicine and Byrd Alzheimer's Institute
- Study Director: Carla Bourne, MD, University of South Florida and Tampa General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
May 21, 2014
First Submitted That Met QC Criteria
May 27, 2014
First Posted (Estimated)
May 30, 2014
Study Record Updates
Last Update Posted (Actual)
June 26, 2024
Last Update Submitted That Met QC Criteria
June 24, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15309
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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