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Vurdering af sikkerheden og effektiviteten af ​​0,1 % RGN-259 oftalmisk opløsning til behandling af NK: SEER-2

4. november 2026 opdateret af: ReGenTree, LLC

Et fase 3, multicenter, randomiseret, parallelt, dobbeltmaskeret, placebokontrolleret klinisk undersøgelse for at vurdere sikkerheden og effektiviteten af ​​0,1 % RGN-259 oftalmisk opløsning til behandling af neurotrofisk 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)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Medicin: 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 navne:
  • 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
Medicin: 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 navne:
  • Køretøjskontrol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Hornhindefølsomhed inde i læsionen bestemt af Cochet Bonnet æstesiometer (Enhed: 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
Foranstaltningsbeskrivelse
Tidsramme
Intraokulært tryk (enhed: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ReGenTree, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. april 2023

Primær færdiggørelse (Faktiske)

28. juli 2026

Studieafslutning (Faktiske)

28. juli 2026

Datoer for studieregistrering

Først indsendt

15. september 2022

Først indsendt, der opfyldte QC-kriterier

22. september 2022

Først opslået (Faktiske)

27. september 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RGN-NK-302

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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