[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurotrophic-keratopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurotrophic-keratopathy":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100408927","autologous-platelet-rich-plasma-aprp-in-the-treatment-of-neurotrophic-keratopathy-100408927",false,"NCT04604834","Autologous Platelet-rich Plasma (APRP) in the Treatment of Neurotrophic Keratopathy","Inclusion Criteria:\n\n* Patients with:\n\n  * Neurotrophic keratopathy diagnosed by esthesiometry (defined as central corneal sensitivity ≤ 3cm using Cochet-Bonnet aesthesiometer).\n  * Corneal erosions.\n  * Neurotrophic keratopathy secondary to: diabetes mellitus, herpetic keratitis, microbial keratitis sequelae (bacteria, Acanthamoeba, fungi, herpes), limbal stem cell deficiency, chemical or thermic burn sequelae at least 3 months after the accident, ocular trauma with penetrating wound fixed at least 3 months before the trial, surgery carried out at least 3 month before the trial (including keratoplasty, laser in situ keratomileusis, phacoemulsification cataract surgery, extracapsular cataract extraction), adenoviral keratoconjunctivitis resolved at least 3 months the trial.\n\nExclusion Criteria:\n\n* Patients diagnosed with:\n\n  * Other ocular surface pathology presenting with corneal erosions but without corneal hyposensitivity.\n  * Corneal epithelial defect with or without corneal hyposensitivity.\n* Pregnant women, homeless, migrants.","ALL","18 Years",{"count":18,"type":19},39,"ESTIMATED","INTERVENTIONAL",[22],"NA","Neurotrophic keratopathy (NK) is a condition where the cornea loses its capacity to feel pain and touch. This causes a decrease in the production of certain substances that maintain the integrity of the corneal epithelium (the most superficial layer that covers the cornea). As a result, the cornea cannot heal wounds as fast as it should and this could lead to corneal breakdown. This disease is chronic, meaning that it does not resolve quickly, and the treatments commonly used to manage it (such as artificial tears) take a long time to work, which makes it hard to follow doctor's orders. Autologous platelet-rich plasma is a substance that is obtained from the patient's own blood and it may contain those components that are missing in the tears of people with NK. The purpose of this experiment is to find out whether APRP+PFAT is better than APRP alone or PFAT alone in the treatment of NK. Participants will be randomly assigned to one of three groups: one group will start with APRP, other will start with PFAT and another with PFAT+APRP. The participants will receive each treatment for four weeks, and then the subjects will switch groups and use them for four weeks each (12 weeks total). Investigators will evaluate different parameters that will let us know if your condition is improving. These evaluations will be carried out every four weeks from the start to the end of the protocol. In case of intolerance or adverse effects, treatment will be discontinued.",[25],"Neurotrophic Keratopathy",[27,28,29],"Autologous PRP","Neurotrophic keratopathy","Autologous platelet-rich plasma","RECRUITING","2026-05-04",{"date":33,"type":34},"2026-05-06","ACTUAL",{"date":36,"type":34},"2020-11-01",{"date":38,"type":19},"2027-12-01",{"name":40,"class":41},"Universidad Autonoma de Nuevo Leon","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100481943","phase-3-assessment-of-the-safety-and-efficacy-of-01-rgn-259-ophthalmic-solution-for-the-treatment-of-nk-seer-2-100481943","NCT05555589","Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2","A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy (SEER-2)","Inclusion Criteria\n\n1. Be male or female of any race, at least 18 years of age;\n2. Have provided written informed consent;\n3. Be able and willing to follow instructions, including participation in all study assessments and visits;\n4. 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 using non-preserved ocular lubricants, non-preserved topical ophthalmic antibiotics, oral doxycycline, patching, amniotic membrane, serum tears, and\u002For therapeutic contact lenses;\n5. 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 by the Investigator not to be simply superficial punctate keratitis, at Visit 1;\n6. Have evidence of decreased corneal sensitivity ≤40 mm using the Cochet-Bonnet aesthesiometer at Visit 1;\n7. Have BCVA score ≤75 letter counts in the study eye based on the ETDRS protocol;\n8. Have at least one eye (the same eye) satisfy all criteria for d, e, f, g above;\n9. Female subjects 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 after last dose, and have a negative urine pregnancy test during screening;\n10. Male subjects must agree to use an adequate method of contraception.\n\nExclusion Criteria\n\n1. 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 efficacy, or would present an undue risk to the subject.\n2. Have any clinically significant slit-lamp findings in the study eye that in the opinion of the Investigator may interfere with the study parameters;\n3. 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 interfere with the study parameters;\n4. Have a Unanesthetized Schirmer's test score of ≤3 mm at Visit 1;\n5. Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the Investigator, is the primary cause of the persistent epithelial defect;\n6. Have an ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g., follicular conjunctivitis) in the study eye.\n7. History of any ocular surgery (including laser or refractive surgical procedures) within the three months before study enrollment.\n8. 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.\n9. Have any planned ocular surgical procedures or are likely to require ocular surgery for the study eye during the study;\n10. Have received Botox® injection to induce blepharoptosis in the study eye within 90 days prior to Visit 1;\n11. 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.\n12. Have used OxervateTM in the study eye within the past 2 months;\n13. Anticipate use of serum tears in the study eye during the study period.\n14. Have a presence or history of any ocular or systemic disorder or condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the Investigator to be incompatible with the study visit schedule or conduct;\n15. 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;\n16. Have any autoimmune or chronic inflammatory disease that might have hindered the efficacy of the study treatment or its evaluation;\n17. Be on topical (Ocular\u002FNasal) immunosuppressive therapy within 30 days prior to screening or is likely to require this during the course of the study;\n18. Have a known allergy and\u002For sensitivity to the study product or its components;\n19. History of drug, medication or alcohol abuse or addiction;\n20. Have participated in an investigational drug study within 30 days prior to screening;\n21. 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.",{"count":51,"type":19},70,[53],"PHASE3","The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)",[25],[57,58],"Neurotrophic Keratitis","NK","2025-12-22",{"date":61,"type":34},"2025-12-23",{"date":63,"type":34},"2023-04-11",{"date":65,"type":19},"2026-05-30",{"name":67,"class":68},"ReGenTree, LLC","INDUSTRY",36]