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Vurdering av sikkerheten og effekten av 0,1 % RGN-259 oftalmisk løsning for behandling av NK: SEER-2

4. november 2026 oppdatert av: ReGenTree, LLC

En fase 3, multisenter, randomisert, parallell, dobbeltmasket, placebokontrollert klinisk studie for å vurdere sikkerheten og effekten av 0,1 % RGN-259 oftalmisk løsning for behandling av nevrotrofisk keratopati (SEER-2)

The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of partial or total impairment of trigeminal innervation. The resulting loss of corneal sensitivity (anesthesia) leads to a reduction in lacrimation and a decline in status, metabolism, and mitosis of corneal epithelial cells.

Studietype

Intervensjonell

Registrering (Faktiske)

70

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Vestavia Hills, Alabama, Forente stater, 35242
        • Parker Cornea
    • California
      • Laguna Hills, California, Forente stater, 92653
        • Harvard Eye Associates
      • Loma Linda, California, Forente stater, 92354
        • Loma Linda University Eye Institute
      • Los Angeles, California, Forente stater, 90013
        • Nvision Clinical Research, LLC
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80909
        • Retina Consultants of Southern Colorado
      • Longmont, Colorado, Forente stater, 80503
        • Advance Vision Research Institute
    • Connecticut
      • Danbury, Connecticut, Forente stater, 06810
        • Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons
    • Florida
      • Crystal River, Florida, Forente stater, 34429
        • Nature Coast Clinical Research
      • Miami, Florida, Forente stater, 33136
        • University of Miami - Bascom Palmer Eye Institute, Miami
      • Tampa, Florida, Forente stater, 33612
        • University of South Florida, Ophthalmolgoy
    • Georgia
      • Sandy Springs, Georgia, Forente stater, 30328
        • Thomas Eye Group, P.C.
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern
    • Indiana
      • Carmel, Indiana, Forente stater, 46290
        • Midwest Cornea Associates, LLC.
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40509
        • Huffman & Huffman, PSC
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • The Johns Hopkins Wilmer Eye Institute
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02111
        • Tufts Medical Center
    • Missouri
      • Chesterfield, Missouri, Forente stater, 63017
        • Midwest Vision Research Foundation
      • St Louis, Missouri, Forente stater, 63108
        • Washington University Eye Center
    • New Jersey
      • Eatontown, New Jersey, Forente stater, 07724
        • Atlantic Eye
      • Palisades Park, New Jersey, Forente stater, 07650
        • Metropolitan Eye Research and Surgery Institute
    • New York
      • The Bronx, New York, Forente stater, 10467
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke Eye Center
      • Raleigh, North Carolina, Forente stater, 27617
        • Oculus Research
      • Shelby, North Carolina, Forente stater, 28150
        • CORE, Inc. / Vita Eye Clinic
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic, Cole Eye Institute
    • Oregon
      • Eugene, Oregon, Forente stater, 97401
        • Pacific ClearVision Institute
      • Medford, Oregon, Forente stater, 97504
        • Cataract & Laser Institute of Southern Oregon
      • Portland, Oregon, Forente stater, 97239
        • OHSU Casey Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Scheie Eye Institute, University of Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC Eye Center
    • South Dakota
      • Rapid City, South Dakota, Forente stater, 57701
        • Black Hills Regional Eye Institute
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt Eye Institute
    • Texas
      • Dallas, Texas, Forente stater, 75231
        • Cornea Associates of Texas
      • Houston, Texas, Forente stater, 77025
        • Houston Eye Associates
      • Mission, Texas, Forente stater, 78572
        • CliniVerse Research
      • San Antonio, Texas, Forente stater, 78212
        • Stuart Terry Eye Associates
      • San Antonio, Texas, Forente stater, 78240
        • MCOA Eye Care
      • Sugar Land, Texas, Forente stater, 77478
        • Berkeley Eye Center
    • Virginia
      • Norfolk, Virginia, Forente stater, 23502
        • Virginia Eye Consultants
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • University of Washington, Department of Ophthalmology
  • Italia
    • Brescia
      • Brescia, Brescia, Italia, 25123
        • Università di Brescia
    • Firenze
      • Florence, Firenze, Italia, 50134
        • Azienda Ospedaliero Universitaria Careggi
    • Lombardy
      • Milan, Lombardy, Italia, 20132
        • Ospedale San Raffaele s.r.l.
      • Milan, Lombardy, Italia, 20142
        • Università degli Studi di Milano - ASST Santi Paolo e Carlo
  • Polen
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polen, 40-594
        • Gabinet Okulistyczny Prof Edward Wylegala
  • Spania
    • Barcelona
      • Barcelona, Barcelona, Spania, 08035
        • IMO Barcelona, Grupo Miranza
    • Córdoba
      • Córdoba, Córdoba, Spania, 14012
        • Hospital La Arruzafa
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spania, 33012
        • Instituto Oftalmológico Fernández-Vega
    • Valencia
      • Valencia, Valencia, Spania, 46004
        • Aiken Prevención & Cirugía Ocular

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

  1. Be male or female of any race, at least 18 years of age;
  2. Have provided written informed consent;
  3. Be able and willing to follow instructions, including participation in all study assessments and visits;
  4. 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/or therapeutic contact lenses;
  5. 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;
  6. Have evidence of decreased corneal sensitivity ≤40 mm using the Cochet-Bonnet aesthesiometer at Visit 1;
  7. Have BCVA score ≤75 letter counts in the study eye based on the ETDRS protocol;
  8. Have at least one eye (the same eye) satisfy all criteria for d, e, f, g above;
  9. 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;
  10. Male subjects must agree to use an adequate method of contraception.

Exclusion Criteria

  1. 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.
  2. Have any clinically significant slit-lamp findings in the study eye that in the opinion of the Investigator may interfere with the study parameters;
  3. 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;
  4. Have a Unanesthetized Schirmer's test score of ≤3 mm at Visit 1;
  5. Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the Investigator, is the primary cause of the persistent epithelial defect;
  6. Have an ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g., follicular conjunctivitis) in the study eye.
  7. History of any ocular surgery (including laser or refractive surgical procedures) within the three months before study enrollment.
  8. 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.
  9. Have any planned ocular surgical procedures or are likely to require ocular surgery for the study eye during the study;
  10. Have received Botox® injection to induce blepharoptosis in the study eye within 90 days prior to Visit 1;
  11. 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.
  12. Have used OxervateTM in the study eye within the past 2 months;
  13. Anticipate use of serum tears in the study eye during the study period.
  14. 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;
  15. 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;
  16. Have any autoimmune or chronic inflammatory disease that might have hindered the efficacy of the study treatment or its evaluation;
  17. 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;
  18. Have a known allergy and/or sensitivity to the study product or its components;
  19. History of drug, medication or alcohol abuse or addiction;
  20. Have participated in an investigational drug study within 30 days prior to screening;
  21. 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 0.1% RGN-259 Opthalmic Solution

It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days
Legemiddel: RGN-259

A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days

Andre navn:
  • Tβ4
  • Thymosin Beta 4
  • Timbetasin
Placebo komparator: Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution)

It is composed of the same excipients as RGN-259 but does not contain Tβ4
Legemiddel: Placebo

It is composed of the same excipients as RGN-259 but does not contain Tβ4. Direct instillation into study eye(s), five times per day for 28 days

Andre navn:
  • Kjøretøykontroll

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of subjects achieving complete healing of PED at Day 29
Tidsramme: Day 29

Percentage of subjects achieving complete healing of the Persistent Epithelial Defect (PED) at Day 29 determined by corneal fluorescein staining as measured by the Central Reading Center.
Day 29

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hornhinnefølsomhet inne i lesjonen bestemt av Cochet Bonnet-estesiometer (Enhet: mm)
Tidsramme: Dag 8, 15, 22, 29, 36 og 43
Dag 8, 15, 22, 29, 36 og 43
Percentage of subjects achieving complete healing of PED at Day 29
Tidsramme: Day 29

Percentage of subjects achieving complete healing of the PED determined by corneal fluorescein staining as measured by the Investigator.
Day 29
Percentage change from baseline of lesion size
Tidsramme: Day 8, 15, 22, 29, 36, and 43

Percentage change from baseline of lesion size determined by corneal fluorescein staining (measurements of greatest dimension of fluorescein staining)
Day 8, 15, 22, 29, 36, and 43
NK stage by Mackie classification
Tidsramme: Day 8, 15, 22, 29, 36, and 43

NK stage graded according to the Mackie classification (Stage I, II, III. Higher scores mean a better or worse outcome)
Day 8, 15, 22, 29, 36, and 43
Visual Acuity determined by ETDRS
Tidsramme: Day 8, 15, 22, 29, 36, and 43

Visual Acuity determined by Early Treatment of Diabetic Retinopathy Study (ETDRS)
Day 8, 15, 22, 29, 36, and 43

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intraokulært trykk (Enhet: mmHg)
Tidsramme: Dag 1, 8, 29 og 43
Dag 1, 8, 29 og 43
Frequency and severity of AEs
Tidsramme: Day 8, 15, 22, 29, 36, and 43

Frequency and severity of AEs as reported according to the NCI CTCAE version 5.0
Day 8, 15, 22, 29, 36, and 43
Number of participants with abnormal vital signs
Tidsramme: Day 1, 8, 15, 22, 29, 36, and 43

Blood pressure, heart rate, respiratory rate, oxygen saturation, and body temperature will be measured and assessed its clinical abnormality.
Day 1, 8, 15, 22, 29, 36, and 43
Dilated fundoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve)
Tidsramme: Day 1, 8, 29 and 43

The fundoscopy exam will be performed and clinical abnormality of vitreous, retina, Macula, Choroid and Optic Nerve will be described.
Day 1, 8, 29 and 43
Slit-lamp biomicroscopy (Cornea, Conjunctiva, Anterior Chamber, Iris, Lens, Lid)
Tidsramme: Day 1, 8, 15, 22, 29, 36, and 43

The Slit-Lamp biomicroscopy will be performed and clinical abnormality of Cornea, Conjunctiva, Anterior Chamber, Iris, Lens and Lid will be described.
Day 1, 8, 15, 22, 29, 36, and 43

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ReGenTree, LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. april 2023

Primær fullføring (Faktiske)

28. juli 2026

Studiet fullført (Faktiske)

28. juli 2026

Datoer for studieregistrering

Først innsendt

15. september 2022

Først innsendt som oppfylte QC-kriteriene

22. september 2022

Først lagt ut (Faktiske)

27. september 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RGN-NK-302

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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