Cenegermin for Neurotrophic Keratopathy

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Toyos Clinic

Must not be taking: Topical glaucoma, Eyelash growth

Disqualifiers: Severe allergy, Active infection, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8-16 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment with Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis

Will I have to stop taking my current medications?

The trial requires that any topical glaucoma or oral medications must have been taken at a stable dose for the past 90 days. Additionally, you cannot use topical dry eye medications within the last month, except for unpreserved artificial tears, which are allowed during the study.

How does the drug cenegermin differ from other treatments for neurotrophic keratopathy?

Cenegermin is unique because it is the first drug specifically approved for neurotrophic keratopathy, using a recombinant human nerve growth factor (rhNGF) to promote healing of the cornea by improving nerve function. Unlike other treatments, it directly addresses the underlying nerve damage, helping to restore corneal sensitivity and heal ulcers without the need for surgery. ^{1 2 3 4 5}

Eligibility Criteria

Adults aged 18-85 with moderate to severe dry eye-related neurotrophic keratitis (NK), experiencing ocular pain and decreased corneal sensitivity, who have tried other treatments without success. Participants must be willing to use effective contraception if of reproductive potential and cannot be pregnant or breastfeeding. Exclusions include recent febrile illness, active infections, hypersensitivity to the study drug, unstable medication doses, and certain prior treatments.

Inclusion Criteria

My eyelids are of normal shape and function.

Provision of signed and dated informed consent form and HIPPA authorization

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Febrile illness within one week of screening visit

I do not have any active infections or eye inflammation.

I will not stop using eyelash growth products during the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cenegermin topical ophthalmic drops 20mcg/ml six times daily for a treatment period of either 8 or 16 weeks

8-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Treatment Details

Interventions

• Cenegermin

Trial Overview The trial is testing Cenegermin Ophthalmic Solution [Oxervate] for treating moderate to severe dry eye-associated NK. It's a Phase 4 study assessing the effects of longer treatment duration on patients' symptoms and healing compared to standard care.

Participant Groups

Group I: 8 week cenegermin treatment Active Control 1 Intervention

All participants receive cenegermin topical ophthalmic drops 20mcg/ml six times daily for a treatment period of either 8 or 16 weeks followed by a follow up period total52 weeks total for each study arm.

Group II: 16 week cenegermin Active Control 1 Intervention

All participants receive cenegermin topical ophthalmic drops 20mcg/ml six times daily for a treatment period of either 8 or 16 weeks followed by a follow up period total52 weeks total for each study arm.

Who Is Running the Clinical Trial?

Toyos Clinic

Lead Sponsor

Trials

9

Recruited

260+

Findings from Research

In a study involving 5 patients with neurotrophic keratopathy, treatment with topical recombinant human nerve growth factor cenegermin 0.02% led to significant healing of corneal ulcers and improved corneal sensitivity after 8 weeks of use, with no adverse events reported.

Cenegermin is recommended as an effective treatment for advanced neurotrophic keratopathy, particularly when used alongside conventional therapies, as it promotes corneal healing and helps maintain corneal surface health without the need for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurotrophic Keratopathy Treated with Topical Recombinant Human Nerve Growth Factor (Cenegermin): Case Series Study with Long-Term Follow-Up. García-Delpech, S., Udaondo, P., Fernández-Santodomingo, AS., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Successful Treatment of a Pediatric Neurotrophic Keratopathy With Cenegermin. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Topical cenegermin 0.002% for pediatric neurotrophic keratopathy. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Neurotrophic Keratopathy Treated with Topical Recombinant Human Nerve Growth Factor (Cenegermin): Case Series Study with Long-Term Follow-Up. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Neurotrophic keratopathy: Clinical presentation and effects of cenegermin. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Long-term clinical efficacy of topical treatment with recombinant human nerve growth factor in neurotrophic keratopathy: a novel cure for a rare degenerative corneal disease? [2022]