GlaucomaNCT02151318
Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies
An observational study of Glaucoma, run by University of South Florida at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having glaucoma and undergoing a trabeculotomy
Who may be able to join
- Patients having glaucoma and undergoing a trabeculotomy
- Sign ICF (Informed Consent Form)
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tampa General Hosipital
Tampa, Florida, 33606
Byrd Alzheimer's Institute
Tampa, Florida, 33613
About this study
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.
- Conditions
- Glaucoma
- Medical subject headings
- Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of new glaucoma medications to reduce TM cellular pathologies associated with the disease glaucoma.
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.
Measured: 6 weeks
Secondary outcomes (1)
Cultured TM cell toxicity caused by new glaucoma medications
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad A Dickey, PhD, Principal investigator, University of South Florida department of Molecular Medicine and Byrd Alzheimer's InstituteCarla Bourne, MD, Study director, University of South Florida and Tampa General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151318
- Sponsor's protocol ID
- 15309
- Status last verified
- Jun 2024
- First submitted
- 21 May 2014
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies
- ClinicalTrials.gov ID
- NCT02151318
- Acronym / sponsor ID
- 15309
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having glaucoma and undergoing a trabeculotomy
Key inclusion criteria (2 listed)
- Patients having glaucoma and undergoing a trabeculotomy
- Sign ICF (Informed Consent Form)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Cultured TM cell toxicity caused by new glaucoma medications
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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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.
Chad A Dickey, PhD principal investigator
University of South Florida department of Molecular Medicine and Byrd Alzheimer's Institute
Carla Bourne, MD study director
University of South Florida and Tampa General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by University of South Florida at 2 sites 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 2 inclusion and 1 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of new glaucoma medications to reduce TM cellular pathologies associated with the disease glaucoma. (time frame: 6 weeks). 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 26 Jun 2024.