What is RGN-259 studying for Neurotrophic Keratopathy?

RGN-259 is being studied to assess its safety and ability to heal corneal damage caused by Neurotrophic Keratopathy. This clinical trial compares the eye drop containing thymosin beta 4 to a placebo to evaluate healing outcomes. The study is sponsored by ReGenTree, LLC and aims to improve treatment options for people with this eye condition.

Who may be eligible for this Neurotrophic Keratopathy clinical trial?

Adults aged 18 years or older with a persistent epithelial defect in one or both eyes and stage 2 or 3 neurotrophic keratopathy may be eligible. Both males and females can participate. Key factors include decreased corneal sensitivity and ability to follow study visits. Please review eligibility criteria for more details.

Is there any cost to participate in this Neurotrophic Keratopathy clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should consider their own travel arrangements when joining the trial.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID05555589

Phase 3 Study of 0.1% RGN-259 Eye Drops for Treating Neurotrophic Keratopathy

Led by ReGenTree, LLC · Updated on 2025-12-23

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Neurotrophic keratopathy NK is a degenerative eye disease caused by damage to the nerves that supply the cornea, leading to reduced sensitivity and impaired healing of the corneal surface. Researchers are evaluating the safety and effectiveness of a new eye drop solution called 0.1% RGN-259 compared to a placebo for treating this condition. This Phase 3, randomized, multi-center clinical study aims to better understand how well RGN-259 helps heal the cornea in people with NK. Participants will be randomly assigned to receive either the RGN-259 eye drops or a placebo solution. Both treatments are preservative-free, sterile eye drops applied directly into the affected eyes five times daily for 28 days. The RGN-259 contains thymosin beta 4 T4, which is being studied for its potential healing properties, while the placebo has the same ingredients except for T4. The study is double-masked to ensure unbiased results. During the study, participants will have regular assessments including eye examinations, measurements of corneal healing, visual acuity tests, and corneal sensitivity checks using specialized tools. The main outcome measured is the percentage of subjects who achieve complete healing of the persistent epithelial defect by Day 29. Follow-up visits will continue up to Day 43 to monitor changes in lesion size and corneal health. Safety will also be closely monitored throughout the trial, which is expected to end in May 2026.

CONDITIONS

Brief Title

Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Be male or female of any race, at least 18 years old
Provide written informed consent
Able and willing to participate in all study assessments and visits
Have a Persistent Epithelial Defect in one or both eyes not healed after at least 1 week of standard treatment
Have stage 2 or 3 neurotrophic keratopathy in at least one eye with defect measuring at least 1 mm
Have decreased corneal sensitivity (40 mm or less) in the study eye
Have a best-corrected visual acuity score of 75 letters or more in the study eye
Female participants of child-bearing potential must be non-lactating, use contraception before and after treatment, and have a negative pregnancy test
Male participants must agree to use adequate contraception

You will not qualify if you...

Any condition interfering with study completion, safety, or data interpretation
Clinically significant slit-lamp findings affecting study parameters
Active blepharitis, meibomian gland dysfunction, lid inflammation, or ocular allergy requiring treatment
Schirmer's test score of 3 mm or less in the study eye
Lid function abnormalities causing the epithelial defect
Ongoing ocular infection or active inflammation in the study eye
Recent ocular surgery within 3 months before enrollment
Prior surgical treatment for NK within 3 months before enrollment except amniotic membrane transplantation
Planned ocular surgery during the study
Botox injection to induce blepharoptosis within 90 days before enrollment
Use of contact lenses within 14 days before enrollment or anticipated during study
Use of Oxervate in the study eye within 2 months
Anticipated use of serum tears during the study
Any ocular or systemic disorder affecting treatment efficacy or study conduct
Use of drugs affecting lacrimation or trigeminal nerve function within 30 days before enrollment
Autoimmune or chronic inflammatory diseases affecting treatment evaluation
Use of topical immunosuppressive therapy within 30 days before screening or during study
Allergy or sensitivity to study product components
History of drug, medication, or alcohol abuse
Participation in another investigational drug study within 30 days before screening
Fever, inflammation, or systemic infection signs including recent COVID-19 infection

Research Team

ReGenTree, LLC

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Phase 3 Study of 0.1% RGN-259 Eye Drops for Treating Neurotrophic Keratopathy

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria