What side effects are associated with this type of intervention?

Common treatments for corneal ulcers include antiviral agents like aciclovir, antibacterial agents, and anti-inflammatory medications such as corticosteroids. Antiviral agents can cause side effects like stinging, burning, and temporary blurred vision. Antibacterial treatments may lead to local irritation, allergic reactions, and, in some cases, antibiotic resistance. Corticosteroids, while effective in reducing inflammation, can increase intraocular pressure, delay wound healing, and increase the risk of secondary infections. It is important to monitor these side effects closely and consult with a healthcare provider for appropriate management.

What prior FDA approvals exist?

The FDA has approved several treatments for corneal ulcers, primarily focusing on antimicrobial and anti-inflammatory therapies. Commonly approved antimicrobial agents include fluoroquinolones like moxifloxacin and gatifloxacin, which are used to treat bacterial infections that can cause corneal ulcers. Anti-inflammatory treatments such as corticosteroid eye drops are also used to reduce inflammation and promote healing. Additionally, regenerative therapies like autologous serum eye drops have been explored for their potential to enhance corneal healing by providing essential growth factors and nutrients. These treatments aim to address the underlying causes of corneal ulcers and support the healing process.

What other types of research exist?

Promising novel alternatives for treating corneal ulcers in 2024 include: 1) Rebamipide ophthalmic suspension, which promotes mucin production and enhances corneal healing. 2) Autologous serum eye drops, which provide essential growth factors and nutrients to support corneal repair. 3) Diquafosol tetrasodium, which stimulates tear secretion and improves ocular surface health. 4) VEGF inhibitors like Conbercept, which can reduce corneal neovascularization and support wound healing. These treatments have shown efficacy in clinical studies and offer potential benefits for corneal ulcer patients.

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KPI-012 for Corneal Ulcers (CHASE Trial)

Phase 2

Recruiting

Research Sponsored by Combangio, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 56

Summary

This trial is testing KPI-012, a stem cell-based eye drop, on patients with a chronic eye condition called PCED. The treatment aims to help heal the eye surface using substances secreted by stem cells.

Who is the study for?

This trial is for individuals with PCED, a type of corneal ulcer, lasting at least 7 days due to conditions like diabetes-related eye disease or infections. Participants should not have had recent eye surgery, be using certain medications, or have severe eyelid issues. Pregnant or breastfeeding individuals are excluded.

What is being tested?

The study aims to test the safety and effectiveness of KPI-012 ophthalmic solution compared to a placebo (vehicle) in treating PCED. It's designed to see if KPI-012 can help heal the cornea better than a non-active solution.

What are the potential side effects?

While specific side effects aren't listed here, typical ones for ophthalmic solutions may include temporary discomfort in the eye, redness, blurred vision, tearing up more than usual or feeling like something is in your eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response status

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2, Arm 2Experimental Treatment1 Intervention

KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days

Group II: Cohort 2, Arm 1Experimental Treatment1 Intervention

KPI-012 Low Dose KPI-012 Ophthalmic Solution 1 U/mL 1 drop 4 times/day for 56 days

Group III: Cohort 1, Arm 1Experimental Treatment1 Intervention

KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days

Group IV: Cohort 2, Arm 3Placebo Group1 Intervention

KPI-012 Vehicle KPI-012 Ophthalmic Solution 0 U/mL 1 drop 4 times/day for 56 days

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for corneal ulcers include antimicrobial agents, anti-inflammatory medications, and regenerative therapies. Antimicrobial agents, such as antibiotics, antifungals, or antivirals, target and eliminate the underlying infectious organisms causing the ulcer, which is crucial for preventing further tissue damage and promoting healing. Anti-inflammatory medications, like corticosteroids, reduce inflammation and immune response, thereby minimizing tissue damage and scarring. Regenerative therapies, such as those involving growth factors or stem cells, aim to enhance the healing of the corneal epithelium and stroma by promoting cell proliferation and tissue repair. These mechanisms are vital for corneal ulcer patients as they address both the cause and the symptoms of the ulcer, leading to improved healing outcomes and preservation of vision.

Keratinocyte growth factor-2 on the proliferation of corneal epithelial stem cells in rabbit alkali burned cornea.