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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of cenegermin eye drops for treating moderate to severe neurotrophic keratopathy, a condition related to nerve damage in the eye that can cause dry eye and corneal issues. Participants will receive the eye drops for either 8 weeks or 16 weeks to determine if a longer treatment period yields better results. It suits those experiencing dry eye discomfort, using artificial tears, and having specific corneal issues unresponsive to regular treatments. As a Phase 4 trial, this research aims to understand how this FDA-approved and proven treatment can benefit more patients.

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.

What is the safety track record for cenegermin?

Research has shown that cenegermin is generally safe for treating neurotrophic keratitis, even in cases related to dry eye. In a study with 151 patients, the treatment was well-tolerated, with most side effects being mild, such as eye irritation or discomfort. The FDA has approved cenegermin for treating neurotrophic keratitis, indicating confidence in its safety.

The treatment uses eye drops, making it easy for patients to apply. While some people might experience mild reactions, these are usually manageable. Patients should always consult a healthcare professional about any concerns before starting treatment. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for neurotrophic keratopathy, which often include artificial tears and therapeutic contact lenses, cenegermin is unique because it uses a nerve growth factor as its active ingredient. This treatment directly targets nerve regeneration and healing of the corneal surface, offering a novel approach that could lead to more effective repair of the damaged eye tissue. Researchers are excited about cenegermin because it addresses the root cause of the condition by stimulating nerve growth, potentially leading to better and faster recovery compared to current options.

What is the effectiveness track record for cenegermin in treating neurotrophic keratopathy?

Studies have shown that cenegermin effectively treats neurotrophic keratopathy (NK), a condition affecting the eye. Many patients experienced complete healing of the cornea, the clear front part of the eye, within eight weeks. It also improves eye sensation and vision, leading to healthier eyes and clearer sight. In this trial, participants will receive cenegermin topical ophthalmic drops for either 8 or 16 weeks. Long-term use of cenegermin has maintained corneal health and resulted in high patient satisfaction. Cenegermin is an approved treatment, proven effective for NK. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12579034/

Cenegermin for the Treatment of Moderate or Severe ... Cenegermin is an approved treatment for neurotrophic keratopathy (NK), however efficacy data outside of United States/European populations are ...

2. oxervate.com oxervate.com/hcp/efficacy-safety/

Efficacy & Safety Many patients in the pivotal trials achieved complete corneal healing at week 8*3. Images are of a clinical trial patient with Stage 2 neurotrophic keratitis ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8850233/

Long-term clinical outcome and satisfaction survey in patients ... Treatment of NK with cenegermin was associated with long-term maintenance of corneal integrity and a higher degree of patient satisfaction.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2451993622002341

Clinical presentation and effects of cenegermin Treatment with cenegermin 20 μg/ml not only promotes corneal epithelial wound healing, but also significantly improves corneal sensitivity and visual acuity.

5. canadianjournalofophthalmology.ca canadianjournalofophthalmology.ca/article/S0008-4182(25)00322-9/fulltext

Cenegermin treatment for pediatric neurotrophic keratopathy Cenegermin is a viable treatment option for pediatric NK, showing efficacy in improving corneal transparency and, to a lesser extent, visual acuity.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37608598/

Ocular adverse events of cenegermin used in neurotrophic ... The safety information on the label is incomplete, and the adverse reactions noted are mostly mild and tolerable. However, the occurrence of ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/761094s001lbl.pdf

BLA 761094/S-001 Page 4 | FDA The efficacy and safety of OXERVATE for the treatment of neurotropic keratitis was studied in a total of 151 patients, evaluated in two 8-week, randomized ...

8. oxervate.com oxervate.com/

Neurotrophic Keratitis Treatment - OXERVATE (cenegermin ... OXERVATE is safe and effective in children two years of age and older. Patient Information · HCP Site; Important Safety Information; Prescribing Information. A ...

9. tandfonline.com tandfonline.com/doi/abs/10.1080/14740338.2023.2251389

Ocular adverse events of cenegermin used in neurotrophic ... The safety information on the label is incomplete, and the adverse reactions noted are mostly mild and tolerable. However, the occurrence of painful epithelial ...