Valutazione della sicurezza e dell'efficacia della soluzione oftalmica allo 0,1% RGN-259 per il trattamento della NK: SEER-2
4 novembre 2026 aggiornato da: ReGenTree, LLC
Uno studio clinico di fase 3, multicentrico, randomizzato, parallelo, in doppia maschera, controllato con placebo per valutare la sicurezza e l'efficacia della soluzione oftalmica RGN-259 allo 0,1% per il trattamento della cheratopatia neurotrofica (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)
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
70
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Brescia
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Brescia, Brescia, Italia, 25123
- Università di Brescia
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Firenze
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Florence, Firenze, Italia, 50134
- Azienda Ospedaliero Universitaria Careggi
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Lombardy
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Milan, Lombardy, Italia, 20132
- Ospedale San Raffaele s.r.l.
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Milan, Lombardy, Italia, 20142
- Università degli Studi di Milano - ASST Santi Paolo e Carlo
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polonia, 40-594
- Gabinet Okulistyczny Prof Edward Wylegala
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Barcelona
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Barcelona, Barcelona, Spagna, 08035
- IMO Barcelona, Grupo Miranza
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Córdoba
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Córdoba, Córdoba, Spagna, 14012
- Hospital La Arruzafa
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Principality of Asturias
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Oviedo, Principality of Asturias, Spagna, 33012
- Instituto Oftalmológico Fernández-Vega
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Valencia
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Valencia, Valencia, Spagna, 46004
- Aiken Prevención & Cirugía Ocular
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Alabama
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Vestavia Hills, Alabama, Stati Uniti, 35242
- Parker Cornea
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California
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Laguna Hills, California, Stati Uniti, 92653
- Harvard Eye Associates
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Loma Linda, California, Stati Uniti, 92354
- Loma Linda University Eye Institute
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Los Angeles, California, Stati Uniti, 90013
- Nvision Clinical Research, LLC
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80909
- Retina Consultants of Southern Colorado
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Longmont, Colorado, Stati Uniti, 80503
- Advance Vision Research Institute
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Connecticut
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Danbury, Connecticut, Stati Uniti, 06810
- Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons
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Florida
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Crystal River, Florida, Stati Uniti, 34429
- Nature Coast Clinical Research
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Miami, Florida, Stati Uniti, 33136
- University of Miami - Bascom Palmer Eye Institute, Miami
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Tampa, Florida, Stati Uniti, 33612
- University of South Florida, Ophthalmolgoy
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Georgia
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Sandy Springs, Georgia, Stati Uniti, 30328
- Thomas Eye Group, P.C.
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern
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Indiana
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Carmel, Indiana, Stati Uniti, 46290
- Midwest Cornea Associates, LLC.
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40509
- Huffman & Huffman, PSC
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- The Johns Hopkins Wilmer Eye Institute
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02111
- Tufts Medical Center
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Missouri
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Chesterfield, Missouri, Stati Uniti, 63017
- Midwest Vision Research Foundation
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St Louis, Missouri, Stati Uniti, 63108
- Washington University Eye Center
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New Jersey
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Eatontown, New Jersey, Stati Uniti, 07724
- Atlantic Eye
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Palisades Park, New Jersey, Stati Uniti, 07650
- Metropolitan Eye Research and Surgery Institute
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New York
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The Bronx, New York, Stati Uniti, 10467
- Montefiore Medical Center
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke Eye Center
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Raleigh, North Carolina, Stati Uniti, 27617
- Oculus Research
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Shelby, North Carolina, Stati Uniti, 28150
- CORE, Inc. / Vita Eye Clinic
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Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic, Cole Eye Institute
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Oregon
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Eugene, Oregon, Stati Uniti, 97401
- Pacific ClearVision Institute
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Medford, Oregon, Stati Uniti, 97504
- Cataract & Laser Institute of Southern Oregon
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Portland, Oregon, Stati Uniti, 97239
- OHSU Casey Eye Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Scheie Eye Institute, University of Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- UPMC Eye Center
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South Dakota
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Rapid City, South Dakota, Stati Uniti, 57701
- Black Hills Regional Eye Institute
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt Eye Institute
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Texas
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Dallas, Texas, Stati Uniti, 75231
- Cornea Associates of Texas
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Houston, Texas, Stati Uniti, 77025
- Houston Eye Associates
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Mission, Texas, Stati Uniti, 78572
- CliniVerse Research
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San Antonio, Texas, Stati Uniti, 78212
- Stuart Terry Eye Associates
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San Antonio, Texas, Stati Uniti, 78240
- MCOA Eye Care
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Sugar Land, Texas, Stati Uniti, 77478
- Berkeley Eye Center
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Virginia
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Norfolk, Virginia, Stati Uniti, 23502
- Virginia Eye Consultants
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Washington
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Seattle, Washington, Stati Uniti, 98104
- University of Washington, Department of Ophthalmology
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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
Altri nomi:
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|
Comparatore placebo: 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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of subjects achieving complete healing of PED at Day 29
Lasso di tempo: Day 29
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Sensibilità corneale all'interno della lesione determinata dall'estesiometro Cochet Bonnet (Unità: mm)
Lasso di tempo: Giorno 8, 15, 22, 29, 36 e 43
|
Giorno 8, 15, 22, 29, 36 e 43
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Percentage of subjects achieving complete healing of PED at Day 29
Lasso di tempo: Day 29
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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
Lasso di tempo: 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
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NK stage by Mackie classification
Lasso di tempo: Day 8, 15, 22, 29, 36, and 43
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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
Lasso di tempo: Day 8, 15, 22, 29, 36, and 43
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Visual Acuity determined by Early Treatment of Diabetic Retinopathy Study (ETDRS) |
Day 8, 15, 22, 29, 36, and 43
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pressione intraoculare (Unità: mmHg)
Lasso di tempo: Giorno 1, 8, 29 e 43
|
Giorno 1, 8, 29 e 43
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Frequency and severity of AEs
Lasso di tempo: 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
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Number of participants with abnormal vital signs
Lasso di tempo: 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)
Lasso di tempo: Day 1, 8, 29 and 43
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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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
11 aprile 2023
Completamento primario (Effettivo)
28 luglio 2026
Completamento dello studio (Effettivo)
28 luglio 2026
Date di iscrizione allo studio
Primo inviato
15 settembre 2022
Primo inviato che soddisfa i criteri di controllo qualità
22 settembre 2022
Primo Inserito (Effettivo)
27 settembre 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 novembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 novembre 2026
Ultimo verificato
1 novembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RGN-NK-302
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .