Is NCT07913074 recruiting in Lynchburg, VA?

Yes, NCT07913074 is currently enrolling participants at its Lynchburg, VA location. This primary open - angle glaucoma (poag) clinical trial is accepting qualified participants.

How do I join the primary open - angle glaucoma (poag) clinical trial in Lynchburg?

To join this clinical trial in Lynchburg, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Lynchburg clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Primary Open - Angle Glaucoma (POAG) Clinical Trial in Lynchburg, VA

About This Primary Open - Angle Glaucoma (POAG) Study in Lynchburg

This study is evaluating a new eye drop containing pregabalin (TB0001) as a potential treatment for people with primary open-angle glaucoma or ocular hypertension. The study aims to determine whether TB0001 lowers eye pressure as effectively as timolol, a commonly used glaucoma eye drop, while remaining safe and well tolerated. Participants will be randomly assigned to receive one of three strengths of TB0001 or timolol for 28 days. Eye pressure, eye health, side effects and tolerability will be assessed throughout the study. The results will help identify the most appropriate dose of TB0001 for future clinical studies.

Sponsor: Tavo Biotherapeutics

Who Can Participate

Inclusion Criteria

Age more than or equal to 18 years.

Diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).

Participants with POAG must have mild to moderate disease, defined as a visual field defect score of less than 12 on the Advanced Glaucoma Intervention Study (AGIS) scale or a Humphrey Mean Deviation (MD)between 0 and -12 dB.

Intraocular Pressure (IOP) Criteria (study eye):

For participants currently receiving IOP-lowering therapy:

There must be documented evidence of a clinically meaningful reduction in IOP in response to currently used IOP-lowering medication(s), as determined by the investigator.

At the Baseline Visit Day -1 (after medication washout), IOP must be between 21 and 32 mmHg, measured at 8:30am ± 1 hour, and demonstrate more than 20% or more than or equal to 3 mmHg increase in IOPcompared to the pre-washout measurement.

For participants not currently receiving IOP-lowering therapy (i.e., untreated POAG or untreated OHT):

No washout is required.

At the Baseline Visit, IOP must be between 21 and 32 mmHg, measured at 8:30am ± 1 hour. Note: All screening IOP assessments must be conducted at 8:30am ± 1 hour to minimize variability due to diurnal fluctuation.

Willing and able to discontinue existing IOP-lowering medication(s) and undergo a washout period of more than 14 days or more than 5 pharmacologic half-lives of the current agent(s), whichever is longer, as determined by the investigator.

Adequate ocular clarity and pupillary dilation to permit reliable ophthalmic assessments, including imaging procedures.

Female subjects:

Women of Non-Childbearing Potential (WONCBP), or

Women of Childbearing Potential (WOCBP) with a negative serum pregnancy test at Screening and Baseline and agreement to use protocol-defined contraception throughout the study.

Male subjects with partners of childbearing potential must agree to use protocol-defined contraception during the study.

Willing and able to provide written informed consent and comply with study procedures, including in-clinic visits and at-home dosing requirements. note: only one eye will be included as a study eye.

Exclusion Criteria

Ocular conditions that could confound study results, including but not limited to uveitis, macular disease, blepharitis, conjunctivitis, or any active ocular infection or inflammation.

History of herpes simplex keratitis.

Severe dry eye disease or a clinical diagnosis of Sjögren's syndrome.

Refractive error exceeding a spherical equivalent of more than 6 dioptres or axial length more than 26mm.

Central corneal thickness less than 500 μm or more than 650 μm.

Intraocular surgery within 3 months prior to Screening.

Ocular trauma within 6 months prior to Screening.

Use of systemic calcium channel blockers that, in the opinion of the investigator, may interfere with study assessments or the mechanism of action of TB0001. • Use of medical or recreational cannabis (marijuana) within 14 days prior to Screening (use during the study period is prohibited).

Participation in another investigational drug or device study within 6 weeks prior to Screening.

Any medical or psychiatric condition that, in the opinion of the investigator, may interfere with study participation, compliance, or interpretation of results.

Advanced primary open-angle glaucoma (POAG), defined as a visual field defect score more than 12 month AGIS scale or a Humphrey Mean Deviation (MD) worse than -12 dB, including subjects with central visual field loss threatening fixation.

Participants for whom washout of IOP-lowering therapy is deemed unsafe, including those with a history of uncontrolled IOP rebound during treatment withdrawal, documented progression of optic nerve damage associated with prior washout attempts, or any other condition where IOP elevation during washout would pose undue risk, in the opinion of the investigator.

Known hypersensitivity or contraindication to pregabalin, timolol, beta-blockers, or any component of the study formulations.

Clinically significant cardiovascular or respiratory conditions that would contraindicate the use of topical beta-blockers, including but not limited to bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, or second- or third-degree atrioventricular block not controlled with a pacemaker.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lynchburg?

Yes, this clinical trial (NCT07913074) has an active research site in Lynchburg, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Primary Open - Angle Glaucoma (POAG) Treatment Options in Lynchburg, VA

If you're searching for primary open - angle glaucoma (poag) treatment options in Lynchburg, VA, this clinical trial (NCT07913074) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lynchburg research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced primary open - angle glaucoma (poag) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all primary open - angle glaucoma (poag) clinical trials near you to find additional studies recruiting in your area.

Primary Open - Angle Glaucoma (POAG) Clinical Trial in Lynchburg, VA

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