ComBaT for Glaucoma

Recruiting at 1 trial location

Overseen By Jade Livingston

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Eye pain, Vision decrease, Double vision, Pregnancy, Prisoners, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether additional resources and education can motivate individuals to visit eye care providers and prevent blindness from glaucoma. It focuses on those diagnosed with glaucoma, at risk for it, or with other serious eye conditions like diabetic retinopathy or macular degeneration. The trial specifically targets Black or African American individuals who have already participated in an initial screening. The study aims to improve access to eye care by changing behavior through education and support. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance eye care access and education for at-risk communities.

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 prior data suggests that this intervention and education protocol is safe for participants?

Research has shown that the safety of the treatment called ComBaT Glaucoma isn't clearly detailed in the available studies. The trial is labeled as "Not Applicable," which might indicate it's in the early research stages or not primarily focused on safety. As a result, safety information might be limited or still being gathered.

However, studies on similar treatments for eye conditions like glaucoma often find that new therapies are generally safe after early research stages. Treatments for other eye issues, such as diabetic macular edema, have been safe for many years, with few serious side effects. This suggests that similar new treatments might also be safe, but specific safety data for ComBaT Glaucoma isn't available yet. Always consult a healthcare provider for personal advice about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for glaucoma, which often involve medications to lower eye pressure, such as beta-blockers or prostaglandin analogs, ComBaT Glaucoma takes a different approach. This innovative treatment targets the underlying mechanisms of eye diseases like glaucoma, diabetic retinopathy, and macular degeneration. Researchers are excited because it could offer a broader application across different eye conditions, potentially improving vision outcomes more effectively than current options. This treatment's unique feature lies in its ability to address multiple eye concerns simultaneously, promising a more comprehensive solution for patients.

What evidence suggests that the ComBaT Glaucoma intervention is effective for improving access to eye care for glaucoma?

Research has shown that starting treatment early for glaucoma can slow the disease and help prevent vision loss. Studies have found that timely care for eye conditions like diabetic retinopathy and glaucoma can stop or slow eye damage. Advanced computer tools now assist doctors in diagnosing these conditions early, which is crucial for effective management. Regular eye check-ups can significantly help those at risk maintain their vision. These findings emphasize the importance of eye care to prevent serious problems like blindness. Participants in the ComBaT for Glaucoma trial will explore early intervention strategies for managing glaucoma and other concerning eye diseases. ^{5 6 7 8 9}

Who Is on the Research Team?

Angela Elam

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ComBaT Glaucoma

Trial Overview 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.

How Is the Trial Designed?

Group I: Eye concern Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Antiglaucoma medications containing benzalkonium chloride (BAK) are linked to adverse ocular reactions like dry eye and burning sensations, which can lead to treatment discontinuation and decreased quality of life for patients.

Clinical studies indicate that switching to preservative-free antiglaucoma treatments can significantly reduce these adverse effects, suggesting important benefits for patient comfort and adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detrimental effect of preservatives in eyedrops: implications for the treatment of glaucoma. Baudouin, C.[2008]

Glaucoma affects approximately 60 million people worldwide, with many cases undiagnosed, highlighting the need for better detection methods since vision loss is irreversible.

Current treatments, primarily daily eye drops, face adherence challenges due to the asymptomatic nature of the disease, but future gene therapy approaches may offer new treatment possibilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glaucoma. Quigley, HA.[2022]

In a survey of 243 glaucoma patients in southern India, 42% reported experiencing problems with their glaucoma medications, which may impact their treatment effectiveness.

The study found that nonadherence to medication was notably higher among unmarried patients and those who had difficulty with the medication bottle, highlighting the need for better support and education for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported barriers to glaucoma medication access, use, and adherence in southern India. Sleath, BL., Krishnadas, R., Cho, M., et al.[2022]

New therapeutic approaches for glaucoma are emerging beyond traditional intraocular pressure reduction, including the use of magnesium, gingko, and fludrocortisone, which can help manage blood pressure and improve vascular regulation.

Experimental strategies show promise in preventing glaucomatous optic neuropathy through various mechanisms, such as inhibiting astrocyte activation and oxidative stress, with potential protective agents including dark chocolate, polyphenolic flavonoids, and melatonin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there more to glaucoma treatment than lowering IOP? Mozaffarieh, M., Flammer, J.[2007]

Future glaucoma treatments aim to not only lower intraocular pressure but also to protect retinal cells from degeneration by targeting various intracellular mechanisms and immunological responses.

Current promising strategies include the use of citicoline to reduce glutamate toxicity, Rho kinase inhibitors for promoting nerve regeneration, and neurotrophic factors to prevent cell damage, alongside emerging immunomodulatory therapies and antioxidants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New perspectives of immunomodulation and neuroprotection in glaucoma. Skopiński, P., Radomska-Leśniewska, DM., Izdebska, J., et al.[2021]

In a study of 165 patients with glaucoma, 38 experienced adverse effects related to the addition of timolol to their treatment regimen.

Timolol had to be discontinued in 15 patients (9%) due to these side effects, indicating a need for further double-masked studies to better understand the safety profile of timolol in glaucoma therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects experienced by patients taking timolol. McMahon, CD., Shaffer, RN., Hoskins, HD., et al.[2019]

The safety profile of glaucoma medications is crucial for treatment adherence, as side effects can lead to patients not following their prescribed therapy.

Long-term use of glaucoma eyedrops, especially those with preservatives, can cause ocular surface changes and systemic effects, highlighting the need for careful selection of medications and patient education on potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of glaucoma medications. Detry-Morel, M.[2018]

In a study involving 3,333 glaucoma patients, 79% reported satisfaction with their topical glaucoma medications, indicating a high level of acceptance among users.

The most commonly prescribed medications, including timolol and latanoprost, showed comparable tolerability, with only a 9% chance of patients needing to change their medication due to side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of commonly used glaucoma medications: comparison of tolerability, chance of discontinuation, and patient satisfaction. Beckers, HJ., Schouten, JS., Webers, CA., et al.[2021]

The traditional focus on lowering intraocular pressure (IOP) as the primary goal in glaucoma management is being challenged, with a call for treatment success to be measured by outcomes beyond IOP.

Current clinical trials in glaucoma are emphasizing patient well-being rather than just IOP reduction, indicating a shift towards evaluating the effectiveness of treatments in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating research into practice: controlled clinical trials and their influence on glaucoma management. Wilson, MR., Gaasterland, D.[2007]

Recent advancements in glaucoma treatment include new topical medications that target the trabecular meshwork and conventional outflow pathways, such as rho kinase inhibitors and nitric oxide donating compounds, which have received FDA approval and aim to reduce intraocular pressure more effectively.

Innovative therapies like gene therapy and stem cell strategies are being developed to provide long-term pressure control without the need for daily eye drops, potentially easing the treatment burden for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glaucoma Drugs in the Pipeline. Kaufman, PL., Mohr, ME., Riccomini, SP., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11881510/

The causal effect of glaucoma and diabetic retinopathy Activation of retinal glial cells contributes to the degeneration of ganglion cells in experimental glaucoma. Prog Retin Eye Res (2023) ...

2. bjo.bmj.com bjo.bmj.com/content/108/7/933

Evaluating the outcome of screening for glaucoma using ... Ocular conditions that are evaluated including DR, treated DR, diabetic macula oedema (DME), age-related macular degeneration (AMD), GS, disc swelling, macular ...

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Deep-Learning–Aided Diagnosis of Diabetic Retinopathy ... In the case of DR and glaucoma, treatment during early stages is effective for slowing disease progression and preventing otherwise incurable vision loss., In ...

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Evaluating the Incidence of Glaucoma, Age-Related ... (2014) Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta- ...

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Recent advances in treating age-related macular ... Neovascular age-related macular degeneration (nAMD) and proliferative diabetic retinopathy (PDR) are major causes of severe vision loss. These ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8573655/

the Fight Glaucoma Blindness! Registry - PMC - PubMed Central ... Glaucoma Ocular Surface Disease Index'. ... Ranibizumab or aflibercept for diabetic macular edema: comparison of 1-year outcomes from the fight ...

7. europe.ophthalmologytimes.com europe.ophthalmologytimes.com/view/perfuse-therapeutics-shares-phase-2-clinical-findings-from-glaucoma-and-diabetic-retinopathy-trials-of-per-001

Perfuse Therapeutics shares findings from glaucoma and ... Control rate of ≥7 dB loss observed in this study is consistent with the natural history of disease (13%) with currently available treatments.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9112957/

Data from the Fight Retinal Blindness! Registry - PMC Conclusion: Aflibercept and ranibizumab were both effective and safe for diabetic macular edema over 3 years. Reported outcomes of diabetic macular edema ( ...

9. perfusetherapeutics.com perfusetherapeutics.com/perfuse-therapeutics-announces-positive-results-from-phase-2-clinical-trials-in-glaucoma-and-diabetic-retinopathy-patients/

Perfuse Therapeutics Announces Positive Results from ... PER-001 intravitreal implant shows potential to be the first disease-modifying treatment for both glaucoma and diabetic retinopathy ...