Evaluación de la seguridad y eficacia de la solución oftálmica RGN-259 al 0,1 % para el tratamiento de la NK: SEER-2
4 de noviembre de 2026 actualizado por: ReGenTree, LLC
Estudio clínico de fase 3, multicéntrico, aleatorizado, paralelo, con doble enmascaramiento y controlado con placebo para evaluar la seguridad y la eficacia de la solución oftálmica RGN-259 al 0,1 % para el tratamiento de la queratopatía neurotrófica (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)
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
70
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Barcelona
-
Barcelona, Barcelona, España, 08035
- IMO Barcelona, Grupo Miranza
-
-
Córdoba
-
Córdoba, Córdoba, España, 14012
- Hospital La Arruzafa
-
-
Principality of Asturias
-
Oviedo, Principality of Asturias, España, 33012
- Instituto Oftalmológico Fernández-Vega
-
-
Valencia
-
Valencia, Valencia, España, 46004
- Aiken Prevención & Cirugía Ocular
-
-
-
-
Alabama
-
Vestavia Hills, Alabama, Estados Unidos, 35242
- Parker Cornea
-
-
California
-
Laguna Hills, California, Estados Unidos, 92653
- Harvard Eye Associates
-
Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Eye Institute
-
Los Angeles, California, Estados Unidos, 90013
- Nvision Clinical Research, LLC
-
-
Colorado
-
Colorado Springs, Colorado, Estados Unidos, 80909
- Retina Consultants of Southern Colorado
-
Longmont, Colorado, Estados Unidos, 80503
- Advance Vision Research Institute
-
-
Connecticut
-
Danbury, Connecticut, Estados Unidos, 06810
- Connecticut Eye Consultants, P.C. Danbury Eye Physicians & Surgeons
-
-
Florida
-
Crystal River, Florida, Estados Unidos, 34429
- Nature Coast Clinical Research
-
Miami, Florida, Estados Unidos, 33136
- University of Miami - Bascom Palmer Eye Institute, Miami
-
Tampa, Florida, Estados Unidos, 33612
- University of South Florida, Ophthalmolgoy
-
-
Georgia
-
Sandy Springs, Georgia, Estados Unidos, 30328
- Thomas Eye Group, P.C.
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60611
- Northwestern
-
-
Indiana
-
Carmel, Indiana, Estados Unidos, 46290
- Midwest Cornea Associates, LLC.
-
-
Kentucky
-
Lexington, Kentucky, Estados Unidos, 40509
- Huffman & Huffman, PSC
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21287
- The Johns Hopkins Wilmer Eye Institute
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02111
- Tufts Medical Center
-
-
Missouri
-
Chesterfield, Missouri, Estados Unidos, 63017
- Midwest Vision Research Foundation
-
St Louis, Missouri, Estados Unidos, 63108
- Washington University Eye Center
-
-
New Jersey
-
Eatontown, New Jersey, Estados Unidos, 07724
- Atlantic Eye
-
Palisades Park, New Jersey, Estados Unidos, 07650
- Metropolitan Eye Research and Surgery Institute
-
-
New York
-
The Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center
-
-
North Carolina
-
Durham, North Carolina, Estados Unidos, 27710
- Duke Eye Center
-
Raleigh, North Carolina, Estados Unidos, 27617
- Oculus Research
-
Shelby, North Carolina, Estados Unidos, 28150
- CORE, Inc. / Vita Eye Clinic
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Cleveland Medical Center
-
Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic, Cole Eye Institute
-
-
Oregon
-
Eugene, Oregon, Estados Unidos, 97401
- Pacific ClearVision Institute
-
Medford, Oregon, Estados Unidos, 97504
- Cataract & Laser Institute of Southern Oregon
-
Portland, Oregon, Estados Unidos, 97239
- OHSU Casey Eye Institute
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- Scheie Eye Institute, University of Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213
- UPMC Eye Center
-
-
South Dakota
-
Rapid City, South Dakota, Estados Unidos, 57701
- Black Hills Regional Eye Institute
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt Eye Institute
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75231
- Cornea Associates of Texas
-
Houston, Texas, Estados Unidos, 77025
- Houston Eye Associates
-
Mission, Texas, Estados Unidos, 78572
- CliniVerse Research
-
San Antonio, Texas, Estados Unidos, 78212
- Stuart Terry Eye Associates
-
San Antonio, Texas, Estados Unidos, 78240
- MCOA Eye Care
-
Sugar Land, Texas, Estados Unidos, 77478
- Berkeley Eye Center
-
-
Virginia
-
Norfolk, Virginia, Estados Unidos, 23502
- Virginia Eye Consultants
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98104
- University of Washington, Department of Ophthalmology
-
-
-
-
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
-
-
-
-
Silesian Voivodeship
-
Katowice, Silesian Voivodeship, Polonia, 40-594
- Gabinet Okulistyczny Prof Edward Wylegala
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
Otros nombres:
|
|
Comparador de placebos: 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
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of subjects achieving complete healing of PED at Day 29
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sensibilidad corneal en el interior de la lesión determinada por el estesiómetro Cochet Bonnet (Unidad: mm)
Periodo de tiempo: Día 8, 15, 22, 29, 36 y 43
|
Día 8, 15, 22, 29, 36 y 43
|
|
|
Percentage of subjects achieving complete healing of PED at Day 29
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Presión intraocular (Unidad: mmHg)
Periodo de tiempo: Día 1, 8, 29 y 43
|
Día 1, 8, 29 y 43
|
|
|
Frequency and severity of AEs
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de abril de 2023
Finalización primaria (Actual)
28 de julio de 2026
Finalización del estudio (Actual)
28 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
15 de septiembre de 2022
Primero enviado que cumplió con los criterios de control de calidad
22 de septiembre de 2022
Publicado por primera vez (Actual)
27 de septiembre de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de noviembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de noviembre de 2026
Última verificación
1 de noviembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RGN-NK-302
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .