Bedömning av säkerhet och effekt av 0,1 % RGN-259 oftalmisk lösning för behandling av NK: SEER-2
4 november 2026 uppdaterad av: ReGenTree, LLC
En fas 3, multicenter, randomiserad, parallell, dubbelmaskad, placebokontrollerad klinisk studie för att bedöma säkerheten och effekten av 0,1 % RGN-259 oftalmisk lösning för behandling av 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)
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
70
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Vestavia Hills, Alabama, Förenta staterna, 35242
- Parker Cornea
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California
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Laguna Hills, California, Förenta staterna, 92653
- Harvard Eye Associates
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Loma Linda, California, Förenta staterna, 92354
- Loma Linda University Eye Institute
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Los Angeles, California, Förenta staterna, 90013
- Nvision Clinical Research, LLC
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80909
- Retina Consultants of Southern Colorado
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Longmont, Colorado, Förenta staterna, 80503
- Advance Vision Research Institute
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Connecticut
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Danbury, Connecticut, Förenta staterna, 06810
- Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons
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Florida
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Crystal River, Florida, Förenta staterna, 34429
- Nature Coast Clinical Research
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Miami, Florida, Förenta staterna, 33136
- University of Miami - Bascom Palmer Eye Institute, Miami
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Tampa, Florida, Förenta staterna, 33612
- University of South Florida, Ophthalmolgoy
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Georgia
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Sandy Springs, Georgia, Förenta staterna, 30328
- Thomas Eye Group, P.C.
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Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern
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Indiana
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Carmel, Indiana, Förenta staterna, 46290
- Midwest Cornea Associates, LLC.
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40509
- Huffman & Huffman, PSC
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- The Johns Hopkins Wilmer Eye Institute
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02111
- Tufts Medical Center
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Missouri
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Chesterfield, Missouri, Förenta staterna, 63017
- Midwest Vision Research Foundation
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St Louis, Missouri, Förenta staterna, 63108
- Washington University Eye Center
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New Jersey
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Eatontown, New Jersey, Förenta staterna, 07724
- Atlantic Eye
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Palisades Park, New Jersey, Förenta staterna, 07650
- Metropolitan Eye Research and Surgery Institute
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New York
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The Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke Eye Center
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Raleigh, North Carolina, Förenta staterna, 27617
- Oculus Research
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Shelby, North Carolina, Förenta staterna, 28150
- CORE, Inc. / Vita Eye Clinic
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic, Cole Eye Institute
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Oregon
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Eugene, Oregon, Förenta staterna, 97401
- Pacific ClearVision Institute
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Medford, Oregon, Förenta staterna, 97504
- Cataract & Laser Institute of Southern Oregon
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Portland, Oregon, Förenta staterna, 97239
- OHSU Casey Eye Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Scheie Eye Institute, University of Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- UPMC Eye Center
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South Dakota
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Rapid City, South Dakota, Förenta staterna, 57701
- Black Hills Regional Eye Institute
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt Eye Institute
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Texas
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Dallas, Texas, Förenta staterna, 75231
- Cornea Associates of Texas
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Houston, Texas, Förenta staterna, 77025
- Houston Eye Associates
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Mission, Texas, Förenta staterna, 78572
- CliniVerse Research
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San Antonio, Texas, Förenta staterna, 78212
- Stuart Terry Eye Associates
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San Antonio, Texas, Förenta staterna, 78240
- MCOA Eye Care
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Sugar Land, Texas, Förenta staterna, 77478
- Berkeley Eye Center
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Virginia
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Norfolk, Virginia, Förenta staterna, 23502
- Virginia Eye Consultants
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Washington
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Seattle, Washington, Förenta staterna, 98104
- University of Washington, Department of Ophthalmology
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Brescia
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Brescia, Brescia, Italien, 25123
- Università di Brescia
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Firenze
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Florence, Firenze, Italien, 50134
- Azienda Ospedaliero Universitaria Careggi
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Lombardy
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Milan, Lombardy, Italien, 20132
- Ospedale San Raffaele s.r.l.
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Milan, Lombardy, Italien, 20142
- Università degli Studi di Milano - ASST Santi Paolo e Carlo
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polen, 40-594
- Gabinet Okulistyczny Prof Edward Wylegala
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Barcelona
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Barcelona, Barcelona, Spanien, 08035
- IMO Barcelona, Grupo Miranza
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Córdoba
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Córdoba, Córdoba, Spanien, 14012
- Hospital La Arruzafa
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Principality of Asturias
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Oviedo, Principality of Asturias, Spanien, 33012
- Instituto Oftalmológico Fernández-Vega
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Valencia
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Valencia, Valencia, Spanien, 46004
- Aiken Prevención & Cirugía Ocular
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion 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 using non-preserved ocular lubricants, non-preserved topical ophthalmic antibiotics, oral doxycycline, patching, amniotic membrane, serum tears, and/or therapeutic contact lenses;
- 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;
- 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 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;
- Male subjects must agree to use an adequate method of contraception.
Exclusion Criteria
- 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.
- 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 interfere with the study parameters;
- 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 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;
- 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 efficacy 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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 |
A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days
Andra namn:
|
|
Placebo-jämförare: Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution)
It is composed of the same excipients as RGN-259 but does not contain Tβ4 |
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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of subjects achieving complete healing of PED at Day 29
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Hornhinnas känslighet inuti lesionen bestäms av Cochet Bonnet estesiometer (Enhet: mm)
Tidsram: Dag 8, 15, 22, 29, 36 och 43
|
Dag 8, 15, 22, 29, 36 och 43
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Percentage of subjects achieving complete healing of PED at Day 29
Tidsram: Day 29
|
Percentage of subjects achieving complete healing of the PED determined by corneal fluorescein staining as measured by the Investigator. |
Day 29
|
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Percentage change from baseline of lesion size
Tidsram: 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
Tidsram: 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
|
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Visual Acuity determined by ETDRS
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intraokulärt tryck (Enhet: mmHg)
Tidsram: Dag 1, 8, 29 och 43
|
Dag 1, 8, 29 och 43
|
|
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Frequency and severity of AEs
Tidsram: 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
Tidsram: 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
|
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Dilated fundoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve)
Tidsram: 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
|
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Slit-lamp biomicroscopy (Cornea, Conjunctiva, Anterior Chamber, Iris, Lens, Lid)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 april 2023
Primärt slutförande (Faktisk)
28 juli 2026
Avslutad studie (Faktisk)
28 juli 2026
Studieregistreringsdatum
Först inskickad
15 september 2022
Först inskickad som uppfyllde QC-kriterierna
22 september 2022
Första postat (Faktisk)
27 september 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 november 2026
Senast verifierad
1 november 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RGN-NK-302
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .