ComBaT for Glaucoma
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Disqualifiers: Eye pain, Vision decrease, Double vision, Pregnancy, Prisoners, Cognitive impairment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this research is to evaluate if intervention and education can change the behavior of someone's willingness to see an eye care provider to prevent blindness and glaucoma. The researchers are investigating if adding additional resources improves participant access to care.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What safety data exists for ComBaT Glaucoma treatment?
The safety of glaucoma medications, including those potentially related to ComBaT Glaucoma, often involves side effects like dry eye and burning sensations, which can lead to stopping the treatment. Preservatives in these medications, such as benzalkonium chloride, are known to cause adverse effects, but preservative-free options may reduce these issues.
12345How does the ComBaT treatment for glaucoma differ from other treatments?
The ComBaT treatment for glaucoma is unique because it may involve a combination of therapies that not only aim to lower intraocular pressure (IOP) but also focus on neuroprotection and immunomodulation, potentially using strategies like gene therapy, antioxidants, and cell transplantation to prevent retinal cell degeneration and improve patient outcomes.
678910Eligibility Criteria
This trial is specifically for Black or African American individuals who have already taken part in the screening exam phase of the study. It aims to see if extra support and education can encourage them to regularly visit eye care professionals, potentially preventing blindness due to glaucoma.Inclusion Criteria
This criterion excludes individuals who are Black or African American.
You have already taken part in the initial screening tests for the study.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive community-engaged and faith-based interventions to increase eye care utilization
6 months
Initial clinical evaluation within 6 months
Follow-up
Participants are monitored for eye care utilization and follow-up evaluations
8 months
Follow-up evaluation at 12 months
Participant Groups
The ComBaT Glaucoma intervention is being tested to determine whether providing additional resources and education can improve a person's likelihood of seeking regular eye care services, which could help prevent vision loss from glaucoma.
1Treatment groups
Experimental Treatment
Group I: Eye concernExperimental Treatment1 Intervention
Those with a diagnosis of glaucoma or glaucoma suspect (or other concerning eye disease, such as diabetic retinopathy or macular degeneration) will be invited to participate in the ComBaT Glaucoma.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Historic King Solomon Baptist ChurchDetroit, MI
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
Side effects of glaucoma medications. [2018]The safety profile of the different glaucoma medications is an important issue when initiating therapy in glaucomatous patients. The decision on which medication to prescribe depends not only on the type of glaucoma, but also on the patient's medical history and needs a detailed knowledge of the potential side-effects of each medication. Medications side effects may be an important cause of non adherence for the individual patient The properties of the drugs, the composition of the glaucoma eyedrops and the dynamics of ocular drug absorption must be considered. The ocular surface changes induced by long-term antiglaucomatous treatment especially by their preservatives are a major cause of intolerance or poor tolerance to glaucoma eyedrops. Moreover topically applied ophthalmic medications can attain sufficient serum levels through absorption into conjunctival and nasal mucosas to have systemic effects and to potentially interact with other drugs. Then this presentation will deal with the ocular and systemic side-effects which can be encountered with the different classes of the currently available glaucoma topical medications. Recommendations than can be applied to reduce both frequency and severity of side-effects of glaucoma medications will be stressed on. Concurrently patients should be fully informed not only about their disease but also the medications they used and what side-effects they have to expect.
Side effects of commonly used glaucoma medications: comparison of tolerability, chance of discontinuation, and patient satisfaction. [2021]To compare the tolerability of commonly prescribed topical glaucoma medications by determining frequency and bother of side effects, patient satisfaction with their medication, and the chance of discontinuation of eye drops.
Detrimental effect of preservatives in eyedrops: implications for the treatment of glaucoma. [2008]Antiglaucoma medications are often associated with ocular adverse reactions such as dry eye, and burning or stinging sensations. These undesirable effects may lead to treatment discontinuation and reduced quality of life in patients with glaucoma. Antiglaucoma medications usually contain benzalkonium chloride (BAK) as a preservative. Animal studies, in vitro studies and in vivo experiments have demonstrated various adverse effects of BAK. Clinical studies have also shown an increased incidence of adverse events with BAK and have demonstrated that the withdrawal of preservatives reduces these effects. Collectively, these data suggest that preservative-free antiglaucoma treatments have clinically relevant benefits for patients.
Adverse effects experienced by patients taking timolol. [2019]Adverse effects involving one or more organ systems occurred in 38 of 165 patients with various types of glaucoma when timolol was added to their glaucoma therapy. It was necessary to discontinue timolol because of these side effects in 15 (9%) of the patients. Double-masked studies will be necessary to clarify the relationship of these adverse effects to the use of timolol.
Patient-reported barriers to glaucoma medication access, use, and adherence in southern India. [2022]The objectives of the study were to (a) describe the different types of problems that patients in southern India reported having when taking their glaucoma medications and (b) examine the relationship between patient reported-problems in taking their glaucoma medications and the self-reported patient adherence. A survey was conducted by clinical staff on 243 glaucoma patients who were on at least one glaucoma medication in an eye clinic in southern India. We found that 42% of patients reported one or more problems in using their glaucoma medications. Approximately 6% of patients reported being less than 100% adherent in the past week. Unmarried patients and patients who reported difficulty squeezing the bottle and difficulty opening the bottle were significantly more likely to report nonadherence.
Glaucoma. [2022]Most medical practitioners have regular contact with adults who have one of the two forms of glaucoma: open-angle glaucoma or angle-closure glaucoma. Data from population-based surveys indicate that one in 40 adults older than 40 years has glaucoma with loss of visual function, which equates to 60 million people worldwide being affected and 8·4 million being bilaterally blind. Even in developed countries, half of glaucoma cases are undiagnosed. Glaucoma is mostly asymptomatic until late in the disease when visual problems arise. Vision loss from glaucoma cannot be recovered, and improved case-detection methods for glaucoma are needed. Glaucoma is commonly treated with daily eye-drop drugs, but adherence to treatment is often unsatisfactory. As a usually asymptomatic and chronic disease, glaucoma has similar treatment challenges to chronic systemic diseases. Similarities to the pathogenesis of common CNS diseases mean that common neuroprotective strategies might exist. Successful gene therapy, which has been used for other eye diseases might be possible for the treatment of glaucoma in the future.
Is there more to glaucoma treatment than lowering IOP? [2007]Classic glaucoma treatment focuses on intraocular pressure (IOP) reduction. Better knowledge of the pathogenesis of the disease has opened up new therapeutical approaches. Whereas most of these new avenues of treatment are still in the experimental phase, others, such as magnesium, gingko, salt and fludrocortisone, are already used by some physicians. Blood pressure dips can be avoided by intake of salt or fludrocortisone. Vascular regulation can be improved locally by carbonic anhydrase inhibitors, and systemically with magnesium or with low doses of calcium channel blockers. Experimentally, glaucomatous optic neuropathy can be prevented by inhibition of astrocyte activation, either by blockage of epidermal growth factor receptor or by counteracting endothelin. Glaucomatous optic neuropathy can also be prevented by nitric oxide-2 synthase inhibition. Inhibition of matrix metalloproteinase-9 inhibits apoptosis of retinal ganglion cells and tissue remodeling. Upregulation of heat shock proteins protects the retinal ganglion cells and the optic nerve head. Reduction of oxidative stress especially at the level of mitochondria also seems to be protective. This can be achieved by gingko; dark chocolate; polyphenolic flavonoids occurring in tea, coffee, or red wine; anthocyanosides found in bilberries; as well as by ubiquinone and melatonin.
New perspectives of immunomodulation and neuroprotection in glaucoma. [2021]Glaucoma is the neurodegenerative disease of retinal ganglion cells. The main risk factor for glaucoma is increased intraocular pressure. The processes leading to cell death due to presence of the injury factor comprise multiple molecular mechanisms, as well as the immunological response. The knowledge of immunological mechanisms occurring in glaucomatous degeneration makes it possible to introduce glaucoma treatment modulating the cellular degradation. The glaucoma treatment of the future will make it possible not only to lower the intraocular pressure, but also to moderate the intracellular mechanisms in order to prevent retinal cell degeneration. Citicoline is a drug modulating glutamate excitotoxicity that is already in use. Rho kinase inhibitors were found to stimulate neurite growth and axon regeneration apart from lowering intraocular pressure. The complementary action of brimonidine is to increase neurotrophic factor (NTF) concentrations and inhibit glutamate toxicity. Immunomodulatory therapies with antibodies and gene therapies show promising effects in the current studies. The supplementation of NTFs prevents glaucomatous damage. Resveratrol and other antioxidants inhibit reactive oxygen species formation. Cell transplantation of stem cells, Schwann cells and nerve extracts was reported to be successful so far. Our review presents the most promising new strategies of neuroprotection and immunomodulation in glaucoma.
Translating research into practice: controlled clinical trials and their influence on glaucoma management. [2007]Historically, management strategies for glaucoma have stressed reduction of IOP as the primary goal. Yet, if we question this principle, we find a deficiency of information to support it as the optimal strategy for managing glaucoma patients and those at risk of developing glaucoma. Thus, the practice of lowering IOP in glaucoma management was placed on trial by the 1987 Eddy and Billings report (D. M. Eddy and J. Billings, 1987). Although generally denounced by clinicians, this report nonetheless alerted the ophthalmologic community that success of glaucoma treatment must be measured by endpoints unrelated to IOP and that a controlled trial to demonstrate glaucoma treatment efficacy was necessary. A clinical trial is an experiment. As such, it is the best study design for inferring causality between an exposure (e.g., IOP) and an outcome (e.g., glaucoma), and it is the best methodology for demonstrating treatment efficacy. However, it is important to understand that efficacy is not the same as effectiveness. Whereas "efficacy" is the extent to which a specific intervention produces a beneficial result under ideal conditions, "effectiveness" is the extent to which a specific intervention, when deployed in the field, does what it is intended to do. The influence of study results on the practice of medicine is more a function of demonstrated effectiveness than efficacy of an intervention. All of the completed glaucoma clinica trials reviewed were well performed, and many have had a substantial influence on the philosophy and practice of glaucoma management. The glaucoma clinical trials currently being performed represent the highest standards of clinical trial methodology. This is an exciting time for clinical research on glaucoma. Well accepted dogmas are being challenged, and the ophthalmic community is aggressively addressing difficult issues. Questions being asked are of fundamental importance and addressing them is essential. Particularly exciting in these trials is the fact that IOP is not being considered as an endpoint and that consideration is being given to the previously ignored but extremely important issue of overall patient well-being. Only with time will the ultimate impact of these trials on the philosophy and practice of glaucoma management become evident.
Glaucoma Drugs in the Pipeline. [2018]Glaucoma is a chronic disease that can be challenging to treat for both patients and physicians. Most patients will require more than 1 medication over time to maintain their intraocular pressure (IOP) at a physiologically benign level. Patients may become refractory to existing compounds and many struggle with adherence to multiple topical drop regimens. The field of glaucoma therapeutics has been advancing rapidly with an emphasis on compounds comprising multiple molecules/mechanisms of action that offer additivity and are complementary to current therapeutics. Several new topical drop compounds directly targeting the trabecular meshwork (TM)/Schlemm canal/conventional outflow pathway to reduce outflow resistance have obtained US Food and Drug Administration approval in the past year. These include rho kinase inhibitors and nitric oxide donating compounds. Alternative therapies that offer long-term IOP lowering while removing the patient from the drug delivery system are moving forward in development. These include gene therapy and stem cell strategies, which could ease or eliminate the burden of topical drop self-administration for several years. Additionally, a variety of novel formulations and devices are in development that aim for controlled, steady state delivery of therapeutics over periods of months. The future of glaucoma therapy is focusing on an increase in specificity for the individual patient: their type of glaucoma; underlying mechanisms; genetic make-up; comorbid conditions; and rate of progression. Maintaining functional vision and improving patient outcomes remains the goal in glaucoma therapeutics. The current collection of novel therapeutics offers an expanded set of tools to achieve that goal.