Corneal Neurotization vs Cenergermin for Neurotrophic Keratopathy

Overseen By Alex Camacho, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Disqualifiers: Ocular infection, Inflammation, others

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

Compensation: Varies

Number of Visits: 16

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for neurotrophic keratitis, a condition where the cornea loses feeling: corneal neurotization surgery and Cenergermin eye drops. The goal is to assess how well these treatments improve vision and quality of life. Doctors, not random assignment, will determine the best treatment for each participant. This trial suits adults with neurotrophic keratitis who have reduced or no corneal sensation and are considering one of these treatments. As an unphased trial, it offers a unique opportunity to explore personalized treatment options and advance care for this condition.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that Cenergermin caused some eye-related side effects, such as eye pain, but these were not serious. Rare reports included painful eye sores and permanent deposits in the eye. Cenergermin has already received approval for treating another eye condition, indicating it has passed strict safety tests.

Research shows that corneal neurotization is generally safe. Most people experienced only minor issues at the donor site, which typically resolved within a year. This procedure has helped many patients regain sensation in their eyes.

Both treatments have demonstrated safety with some minor risks. Discuss any concerns with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for neurotrophic keratopathy, which often involve lubricating eye drops or therapeutic lenses, Cenergermin offers a novel approach by using a recombinant human nerve growth factor. This eye drop aims to heal the cornea by promoting nerve regeneration, which is something traditional treatments don't typically address. On the other hand, corneal neurotization is an innovative surgical technique that transfers healthy nerves to restore sensation to the cornea, potentially offering a more permanent solution. Researchers are excited about these treatments because they both target the underlying nerve damage, which could lead to more effective and lasting results compared to conventional therapies.

What evidence suggests that this trial's treatments could be effective for neurotrophic keratopathy?

This trial will compare Cenergermin with corneal neurotization for treating neurotrophic keratopathy (NK). Studies have shown that Cenergermin, an eye drop treatment, effectively treats NK, with many patients experiencing complete healing in about eight weeks. Cenergermin also improves eye sensitivity and vision. In contrast, corneal neurotization surgery greatly enhances vision and eye sensation in NK patients. Research indicates that most patients achieve full eye healing in about four months with this surgery. Both treatments have shown promising results for people with NK. ^{1 2 6 7 8}

Who Is on the Research Team?

Monali Malvankar, PhD, Professor

Principal Investigator

Western University, Ophthalmology

Anastasiya Vinokurtseva, MD, Resident

Principal Investigator

Western University, Ophthalmology

Alex Camacho, MD, MSc

Principal Investigator

Western University, Ophthalmology

Cindy Hutnik, MD, PhD, Department Chief

Principal Investigator

Western University, Ophthalmology

Are You a Good Fit for This Trial?

This trial is for individuals with neurotrophic keratitis, a condition causing corneal sensory dysfunction. Participants will be chosen based on clinical decision-making rather than random selection and must commit to eight visits over 12 months at the Ivey Eye Institute.

Inclusion Criteria

My eye doctor says I need special treatment for my cornea.

I am 19 years old or older.

Ability to provide informed consent

Exclusion Criteria

I have had a corneal nerve repair surgery in my affected eye.

Participation in another interventional clinical trial within the past 3 months

I currently have an eye infection or inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either corneal neurotization surgery or topical Cenergermin (Oxervate) based on clinical decision-making

12 months

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cenergermin
• Corneal Neurotization

Trial Overview The study compares two treatments: corneal neurotization surgery and topical Cenergermin (Oxervate). It aims to evaluate feasibility, visual outcomes, corneal health, and patient well-being through routine exams and questionnaires.

How Is the Trial Designed?

Group I: Corneal Neurotization Experimental Treatment 1 Intervention

Participants in this arm will receive corneal neurotization surgery as part of their standard clinical care. The surgical procedure involves transferring healthy donor nerves to the anesthetic cornea in order to restore corneal sensation. Participants are followed over 12 months without randomization.

Group II: Cenergermin Active Control 1 Intervention

Participants in this arm will receive topical Cenergermin (Oxervate) eye drops, a recombinant human nerve growth factor approved for treatment of neurotrophic keratitis. Treatment is selected based on clinical decision-making. Participants are followed over 12 months as part of routine care.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

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. aao.org aao.org/editors-choice/cenergermin-appears-effective-neurotrophic-keratit

Cenergermin appears effective for neurotrophic keratitis ... This study evaluated the efficacy and safety outcomes of eyes with neurotrophic keratitis (NK) that underwent a course of cenegermin-bkbj (Oxervate) in the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07073729

Corneal Neurotization vs. Cenergermin for Neurotrophic ... This pilot study evaluates the feasibility and outcomes of two treatment approaches for corneal sensory dysfunction due to neurotrophic keratitis (NK): corneal ...

5. 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.

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

Ocular adverse events of cenegermin used in neurotrophic ... The occurrence of painful epithelial plagues and irreversible corneal deposits after cenegermin usage have been reported.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0161642019319505

Topical Recombinant Human Nerve Growth Factor ... Purpose. To evaluate the efficacy and safety of topical cenegermin (recombinant human nerve growth factor) in patients with neurotrophic keratopathy. Design.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04627571

Corneal Nerves After Treatment With Cenegermin Neurotrophic keratopathy (NK) is a condition in which patients have fewer or complete absence of nerves in the cornea, characterized by the reduced or absent ...