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Beoordeling van de veiligheid en werkzaamheid van 0,1% RGN-259 oogheelkundige oplossing voor de behandeling van NK: SEER-2

4 november 2026 bijgewerkt door: ReGenTree, LLC

Een fase 3, multicenter, gerandomiseerd, parallel, dubbel gemaskeerd, placebogecontroleerd klinisch onderzoek om de veiligheid en werkzaamheid te beoordelen van 0,1% RGN-259 oftalmische oplossing voor de behandeling van neurotrofische keratopathie (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)

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

70

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Geneesmiddel: 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

Andere namen:
  • Tβ4
  • Thymosine Beta 4
  • Timbetasine
Placebo-vergelijker: Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution)

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

Andere namen:
  • Voertuig Controle

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of subjects achieving complete healing of PED at Day 29
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hoornvliesgevoeligheid in de laesie bepaald door Cochet Bonnet aesthesiometer (Eenheid: mm)
Tijdsspanne: Dag 8, 15, 22, 29, 36 en 43
Dag 8, 15, 22, 29, 36 en 43
Percentage of subjects achieving complete healing of PED at Day 29
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intraoculaire druk (eenheid: mmHg)
Tijdsspanne: Dag 1, 8, 29 en 43
Dag 1, 8, 29 en 43
Frequency and severity of AEs
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

ReGenTree, LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 april 2023

Primaire voltooiing (Werkelijk)

28 juli 2026

Studie voltooiing (Werkelijk)

28 juli 2026

Studieregistratiedata

Eerst ingediend

15 september 2022

Eerst ingediend dat voldeed aan de QC-criteria

22 september 2022

Eerst geplaatst (Werkelijk)

27 september 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

4 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RGN-NK-302

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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