What side effects are associated with this type of intervention?

Common treatments for pterygium, particularly anti-inflammatory and anti-angiogenic therapies, can have several side effects. Anti-inflammatory treatments like corticosteroid eye drops may lead to increased intraocular pressure, cataract formation, and delayed wound healing. Anti-angiogenic treatments, such as bevacizumab, can cause eye irritation, redness, and in rare instances, more severe complications like infection or retinal detachment. These treatments aim to reduce inflammation and prevent pterygium progression but require careful monitoring for adverse effects.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved eye drops for the treatment of pterygium that are explicitly anti-inflammatory or anti-angiogenic. The standard treatments for pterygium primarily involve surgical removal, and post-surgical management may include anti-inflammatory medications such as corticosteroid eye drops to reduce inflammation and prevent recurrence. Anti-angiogenic treatments, which inhibit blood vessel growth, are not commonly used for pterygium but are being explored in clinical trials like the one for CBT-001 eye drops.

What other types of research exist?

Promising alternatives to CBT-001 eye drops for pterygium treatment include topical cyclosporine A 0.05%, which has shown efficacy in reducing inflammation and improving meibomian gland function, and photodynamic therapy, which has been effective in treating various ocular surface diseases. Both treatments have demonstrated potential in clinical settings and could be considered for pterygium management in 2024.

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CBT-001 Eye Drops for Pterygium

Phase 3

Recruiting

Led By Bruce A Segal, ND

Research Sponsored by Cloudbreak Therapeutics, LLC

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

Pivotal Trial

Summary

This trial is testing CBT-001 eye drops to see if they can reduce eye redness and stop tissue growth in people with pterygia. The drops are used regularly over an extended period. The goal is to find out if these drops work effectively and are safe to use.

Who is the study for?

This trial is for individuals at least 12 years old with pterygium and good general health. They must have a visual acuity of 20/200 or better in one eye, agree to use contraception if applicable, and not be pregnant or nursing. Excluded are those with uncontrolled diseases like cancer, active ocular infections, significant corneal abnormalities unrelated to pterygium, recent eye surgeries (except for pterygium excision), severe seasonal ocular allergies, history of ocular herpes or trauma.

What is being tested?

The trial tests the safety and effectiveness of CBT-001 emulsion at two different concentrations (0.1% and 0.2%) against a placebo vehicle. Participants will apply the treatment twice daily for two years to see if it reduces redness and prevents the growth of their pterygium.

What are the potential side effects?

While specific side effects aren't listed here, participants may experience reactions related to eye treatments such as irritation, discomfort, redness or allergic responses due to sensitivity towards components in CBT-001.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

conjunctival hyperemia

pterygium length

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: CBT-001 Low DoseExperimental Treatment1 Intervention

CBT-001 eye drop

Group II: CBT-001 High DoseExperimental Treatment1 Intervention

CBT-001 eye drop

Group III: VehiclePlacebo Group1 Intervention

Emulsion eye drop without drug

Do I qualify?Apply below to find out

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 Pterygium, such as anti-inflammatory and anti-angiogenic therapies, work by targeting the underlying processes that contribute to the growth and progression of the condition. Anti-inflammatory treatments reduce inflammation in the conjunctiva, which can help alleviate symptoms like redness and irritation. Anti-angiogenic treatments inhibit the formation of new blood vessels, which is crucial because excessive vascularization can lead to the growth and recurrence of Pterygium. These mechanisms are important for Pterygium patients as they address both the symptoms and the root causes of the condition, potentially reducing the need for surgical intervention and improving overall eye health.