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Tests treatment safety and results for Neurotrophic Keratopathy
Official title Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
ClinicalTrials.gov ID: NCT05555589
What this study is testing
What is RGN-259?
RGN-259 is an investigational medicine, being studied as a potential treatment for neurotrophic keratopathy.
Also referred to as Tβ4, Thymosin Beta 4.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be male or female of any race, at least 18 years of age;
- Have provided written informed consent;
- Be able and willing to follow instructions, including participation in all study assessments and visits;
- At the time of Visit 1, have documentation or observation of a Persistent Epithelial Defect (PED) in one or both eyes, defined as a corneal...
- Have stage 2 or 3 neurotrophic keratopathy (Mackie Classification) in at least one eye of which the longest dimension (length or width) of the defect...
You likely can't join if
- Have any condition that, in the opinion of the Investigator, would interfere with the subject's ability to complete the study, would interfere with...
- Have any clinically significant slit-lamp findings in the study eye that in the opinion of the Investigator may interfere with the study parameters;
- Clinically significant active blepharitis, meibomian gland dysfunction (MGD), or lid margin inflammation, or active ocular allergy in study eye that...
- Have a Unanesthetized Schirmer's test score of ≤3 mm at Visit 1;
- Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the Investigator, is the primary cause of the persistent epithelial...
- Have an ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g., follicular conjunctivitis) in the study eye.
See the full eligibility criteria
- Be male or female of any race, at least 18 years of age;
- Have provided written informed consent;
- Be able and willing to follow instructions, including participation in all study assessments and visits;
- At the time of Visit 1, have documentation or observation of a Persistent Epithelial Defect (PED) in one or both eyes, defined as a corneal epithelial defect that has not resolved after 1 week of conventional treatment...
- Have stage 2 or 3 neurotrophic keratopathy (Mackie Classification) in at least one eye of which the longest dimension (length or width) of the defect measures a minimum length of 1 mm (study eye) and which is confirmed...
- Have evidence of decreased corneal sensitivity ≤40 mm using the Cochet-Bonnet aesthesiometer at Visit 1;
- Have BCVA score ≤75 letter counts in the study eye based on the ETDRS protocol;
- Have at least one eye (the same eye) satisfy all criteria for d, e, f, g above;
- Female people of child-bearing potential must be non-lactating and using and agree to continue using an acceptable method of contraception for at least 4 weeks prior to the first dose of study product and until 12 weeks...
- Male people must agree to use an adequate method of contraception.
- Have any condition that, in the opinion of the Investigator, would interfere with the subject's ability to complete the study, would interfere with the interpretation of safety or how well it works, or would present an...
- Have any clinically significant slit-lamp findings in the study eye that in the opinion of the Investigator may interfere with the study parameters;
- Clinically significant active blepharitis, meibomian gland dysfunction (MGD), or lid margin inflammation, or active ocular allergy in study eye that requires treatment that in the opinion of the investigator may...
- Have a Unanesthetized Schirmer's test score of ≤3 mm at Visit 1;
- Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the Investigator, is the primary cause of the persistent epithelial defect;
- Have an ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g., follicular conjunctivitis) in the study eye.
- History of any ocular surgery (including laser or refractive surgical procedures) within the three months before study enrollment.
- Prior surgical procedure(s) for the treatment of NK (e.g., tarsorrhaphy, conjunctival flap, etc.) within the three months before study enrollment with the exception of amniotic membrane transplantation.
- Have any planned ocular surgical procedures or are likely to require ocular surgery for the study eye during the study;
- Have received Botox® injection to induce blepharoptosis in the study eye within 90 days prior to Visit 1;
- Have used contact lenses (for therapeutic or refractive correction) in the study eye within 14 days prior to Visit 1, or anticipate use of contact lenses during the study period.
- Have used OxervateTM in the study eye within the past 2 months;
- Anticipate use of serum tears in the study eye during the study period.
- Have a presence or history of any ocular or systemic disorder or condition that might hinder the how well it works of the study treatment or its evaluation, could possibly interfere with the interpretation of study...
- Have used drugs which affect lacrimation or function of the trigeminal nerve within 30 days of Visit 1 or anticipate use of these systemic medication throughout the course of the study;
- Have any autoimmune or chronic inflammatory disease that might have hindered the how well it works of the study treatment or its evaluation;
- Be on topical (Ocular/Nasal) immunosuppressive therapy within 30 days prior to screening or is likely to require this during the course of the study;
- Have a known allergy and/or sensitivity to the study product or its components;
- History of drug, medication or alcohol abuse or addiction;
- Have participated in an investigational drug study within 30 days prior to screening;
- Have fever, inflammation, or systemic signs of illness suggestive of systemic or invasive infection, including COVID-19 or a positive test for COVID-19, within 2 weeks prior to first dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Laguna Hills, California, United States
- Loma Linda, California, United States
- Colorado Springs, Colorado, United States
- Longmont, Colorado, United States
- Danbury, Connecticut, United States
- Crystal River, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Sandy Springs, Georgia, United States
- Chicago, Illinois, United States
- Carmel, Indiana, United States
- Lexington, Kentucky, United States
- Chesterfield, Missouri, United States
- St Louis, Missouri, United States
- Palisades Park, New Jersey, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
- Raleigh, North Carolina, United States
- Shelby, North Carolina, United States
- Cleveland, Ohio, United States
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Laguna Hills, California, United States; Loma Linda, California, United States; Colorado Springs, Colorado, United States; Longmont, Colorado, United States; Danbury, Connecticut, United States; Crystal River, Florida, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.