Un estudio de fase 2 de eficacia y seguridad de GAL-101, solución oftálmica al 2% en la atrofia geográfica no foveal secundaria a DMAE no neovascular (eDREAM)
Un estudio de fase 2, doble enmascarado, aleatorizado, multicéntrico, de grupos paralelos y controlado con placebo para investigar la eficacia y seguridad de la solución oftálmica GAL-101 al 2% en pacientes con atrofia geográfica no foveal secundaria a edad no neovascular. Degeneración Macular relacionada: Estudio EDREAM
Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In this study, if both eyes qualify for the study, the eye with the better BCVA will be defined as the study eye. If both eyes qualify for the study and have identical BCVA, then the eye with higher baseline peripheral retinal degenerations (PRD) will be defined as the study eye. If baseline PRD is identical, then the right eye (OD) will be defined as the study eye. Only the study eye will be dosed with the Investigation Medicinal Product (IMP).
During visits, patients will administer 3 applications of 1 drop of GAL-101 or a matching Placebo that does not contain the active pharmaceutical ingredient (API) at 5-minute intervals (i.e., 1st application, wait 5 minutes, 2nd application, wait 5 minutes, 3rd application), under the supervision of trained and authorized study personnel. In between visits, patients will be instructed to administer 2 applications of 1 drop at 5-minute intervals once a day.
The study will be comprised of a 12- to 24-month treatment period determined individually according to patients' overall placement in global study randomization. All patients will participate at least 12 months of treatment. The visit schedule includes the following: Screening visits (Visit 1a and 1b) for image capture and confirmation of study eligibility by a reading center; Baseline/Randomization/Day 1 (Visit 2); a phone call at 2 weeks; and on-treatment clinic visits for safety and efficacy evaluations at 1 month, 3 months, 6 months, 9 months, and 12 months. Patients will continue to attend on-treatment clinic visits at 3-month intervals after 12 months until the last patient randomized in the study has completed 12 months of study treatment.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Galimedix Inc. c/o Imperial CRS, MD
- Número de teléfono: +1 (301) 9179191
- Correo electrónico: info@galimedix.com
Copia de seguridad de contactos de estudio
- Nombre: Luciana Summo, PhD
- Correo electrónico: info@galimedix.com
Ubicaciones de estudio
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Bonn, Alemania, 53127
- Reclutamiento
- Universitäts-Augenklinik Bonn
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Investigador principal:
- Kristina Pfau, MD
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Contacto:
- Joanna Czauderna Study Coordinator
- Número de teléfono: 0228 287-11493
- Correo electrónico: Joanna.Czauderna@ukbonn.de
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Freiburg im Breisgau, Alemania, 79106
- Reclutamiento
- Universitätsklinikum Freiburg Klinik für Augenheilkunde
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Investigador principal:
- Hansjuergen Agostini, MD
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Contacto:
- Christine Kremer
- Número de teléfono: +49 761 270 40231
- Correo electrónico: christine.kremer@uniklinik-freiburg.de
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Hanover, Alemania, 30625
- Reclutamiento
- Medizinische Hochschule Hannover Augenklinik
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Contacto:
- Irene Oluwatoba-Popoola
- Correo electrónico: Oluwatoba-popoola.irene@mh-hannover.de
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Investigador principal:
- Ekaterina Sokolenko, MD
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Neubrandenburg, Alemania, 17036
- Reclutamiento
- Dietrich Bonhoeffer Klinikum
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Contacto:
- Ulrike Holland
- Número de teléfono: +49 395 775 13427
- Correo electrónico: aug-st2@dbknb.de
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Investigador principal:
- Christian Brinkmann, MD
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Tübingen, Alemania, 72076
- Reclutamiento
- Universitätsklinikum Tübingen, Department für Augenheilkunde.
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Contacto:
- Angela Geiger
- Correo electrónico: Felix.Reichel@med.uni-tuebingen.de
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Investigador principal:
- Felix Reichel, MD
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Ulm, Alemania, 89075
- Aún no reclutando
- UNIVERSITÄTSKLINIKUM ULM Klinik für Augenheilkunde
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Contacto:
- Julia Ciboci
- Correo electrónico: Julia.Ciboci@uniklinik-ulm.de
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Investigador principal:
- Armin Wolf, MD
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Yerevan, Armenia, 0048
- Reclutamiento
- Ophthalmological Center After S.V. Malayan
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Contacto:
- Ani Babayan
- Número de teléfono: +37494909990
- Correo electrónico: babayanani88@yahoo.com
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Investigador principal:
- Lilit Voskanyan, MD, PhD
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California
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Beverly Hills, California, Estados Unidos, 90211
- Reclutamiento
- Retina-Vitreous Associates Medical Group
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Investigador principal:
- David Boyer, MD
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Contacto:
- Rahul Araza
- Número de teléfono: 3 (310) 289-2478
- Correo electrónico: raraza@laretina.com
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Walnut Creek, California, Estados Unidos, 94598
- Reclutamiento
- Bay Area Retina Associates
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Investigador principal:
- Roger Goldberg, MD
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Contacto:
- Karrie Padilla
- Número de teléfono: 925-265-4146
- Correo electrónico: kpadilla@bayarearetina.com
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Maryland
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Hagerstown, Maryland, Estados Unidos, 21740
- Suspendido
- Cumberland Valley Retina Consultants
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Bordeaux, Francia, 33000
- Reclutamiento
- Centre Rétine Gallien
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Contacto:
- Manon Demeurs
- Número de teléfono: 33 (5) 56 11 32 25
- Correo electrónico: arc@retinegallien.com
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Investigador principal:
- Eric Fourmaux, MD
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Lyon, Francia, 69317
- Reclutamiento
- Hopital de La Croix-Rousse Service D'Ophtalmologie Groupement Hospitalier Nord Hospices Civils de Lyon
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Contacto:
- Roxane Bai
- Número de teléfono: +33 (0)4 26 73 27 02
- Correo electrónico: roxane.bai@chu-lyon.fr
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Investigador principal:
- Laurent KODJIKIAN, MD
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Marseille, Francia, 13008
- Reclutamiento
- Centre Monticelli Paradis d'Ophtalmologie
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Contacto:
- Agné Devin Dr.
- Número de teléfono: 049116 05 84
- Correo electrónico: agne.retine@gmail.com
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Investigador principal:
- François Devin, MD
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Paris, Francia, 75006
- Reclutamiento
- Centre Ophtalmologique Odéon
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Contacto:
- Sumeyye OZALTUN
- Correo electrónico: ozalt.sumeyye@gmail.com
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Contacto:
- Favard, MD
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Investigador principal:
- Catherine Favard, MD
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Tours, Francia, 37540
- Reclutamiento
- Centre médico-chirurgical de Touraine
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Contacto:
- Sarah Van Herreweghe
- Número de teléfono: 33 (0)2 47 64 67 27
- Correo electrónico: svanherreweghe6@gmail.com
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Investigador principal:
- Sam Razavi, MD
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Tbilisi, Georgia, 0162
- Reclutamiento
- Akhali Mzera Limited
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Contacto:
- Revaz Bezarashvili
- Número de teléfono: (+995) 555 55 54 82
- Correo electrónico: rezieye@gmail.com
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Investigador principal:
- Shalva Skhirtladze, MD
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Tbilisi, Georgia, 0186
- Reclutamiento
- Caucasus Medical Centre LLC
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Contacto:
- Sopio Tsiklauri, MD
- Número de teléfono: (+995) 595 974 774
- Correo electrónico: soffia01@yahoo.com
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Investigador principal:
- Mikheil Omiadze, MD, PhD
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Kildare, Irlanda, W91 W535
- Reclutamiento
- UPMC Kildare Hospital Prosperous Rd Clane, Kildare Ireland
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Investigador principal:
- Eugene Ng, MD
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Contacto:
- Hiella Akhundova
- Número de teléfono: +353 89 411 2119
- Correo electrónico: hiella.a@ioes.ie
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Waterford, Irlanda, X91 DH9W
- Reclutamiento
- Institute of Eye Surgery (IOES Waterford)
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Investigador principal:
- Eugene Ng, MD
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Contacto:
- Emmanuel Ankamah
- Número de teléfono: +353 89 411 2119
- Correo electrónico: emmanuel.a@ioes.ie
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Jerusalem, Israel, 9112001
- Reclutamiento
- Hadassah Medical Center
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Contacto:
- Michal Shpigel
- Número de teléfono: 972-54-4575921
- Correo electrónico: smichal@hadassah.org.il
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Investigador principal:
- Tareq Jaouni, MD
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Tel Aviv, Israel, 6423906
- Reclutamiento
- Tel Aviv Medical Center
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Contacto:
- Marina Gordon
- Número de teléfono: 972-3-6947371
- Correo electrónico: marinago@tlvmc.gov.il
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Investigador principal:
- Omer Trivizki, MD
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Milano
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Milan, Milano, Italia, 20123
- Reclutamiento
- Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe
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Contacto:
- Mara Cattaneo Study Coordinator
- Correo electrónico: mara.cattaneo@multimedica.it
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Investigador principal:
- Stela Vujosevic, MD
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Milan, Milano, Italia, 20132
- Reclutamiento
- Unità di Oculistica, IRCCS Ospedale San Raffaele
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Contacto:
- Adelaide Pina Study Coordinator
- Número de teléfono: 0226433545
- Correo electrónico: pina.adelaide@hsr.it
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Investigador principal:
- Francesco Bandello, MD
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Roma
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Roma, Roma, Italia, 00184
- Reclutamiento
- UOS Retina Medica, P.O. Britannico, IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia
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Contacto:
- Ilaria Casale, Dr
- Correo electrónico: ilaria.casale@fondazionebietti.it
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Investigador principal:
- Mariacristina Parravanno, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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≥55 years of age
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Willing and able to provide written informed consent
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Willing and able to comply with the study schedule and study assessments
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Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution
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BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will be confirmed at Baseline
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Refractive error between +3 and -6 diopters spherical equivalent in the study eye
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Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline
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Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center
- Well-delineated cumulative GA area between 1.25 and 12.0 mm2
- If GA is multifocal, at least 1 lesion ≥1.25 mm2
- GA lesions must be located outside a ≥100 µm radius from the center point of the fovea (i.e., this area must have intact retinal pigment epithelium [RPE] and outer retina)
- GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea
- GA lesions must be completely located within FAF imaging field (field 2 to 30-degree image centered on the fovea). GA lesion borders must be >300 µm from image edges
- GA lesions must be >300 µm from the optic disc and/or peripapillary atrophy
- Area of PRD must be cumulatively between 7.25 and 25.0 mm2
Exclusion Criteria:
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Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline
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History of laser therapy in the macular region, regardless of indication
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History of herpes zoster
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Ophthalmic disease or condition that requires or is likely to require surgery during the study period
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GA with cumulative area <1.25 mm2
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Any GA lesion within 100 µm radius from the center point of the fovea
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Axial length >26 mm
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Any ocular disease or condition other than non-neovascular AMD that may, in the opinion of the Investigator, interfere with study assessments, patient adherence to the study schedule, or interpretation of study data (e.g., epiretinal membrane, macular hole, glaucomatous optic neuropathy, etc.)
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Intraocular surgery (including cataract extraction and crystalline lens replacement) within 3 months before Visit 1a or yttrium aluminum garnet (YAG) surgery within 2 months before Visit 1a, or planned either during the study period
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Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, or planned use during the study period
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Use of any prescription or over-the-counter ophthalmic medication within 1 month before Visit 1a or planned use during the study period
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Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period
Non-study Eye:
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BCVA of <5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent)
Either Eye:
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History of uveitis
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GA secondary to any condition other than non-neovascular AMD
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History of active ocular infection or inflammation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline
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Underwent investigational treatment for AMD within 6 months before Visit 1a
General Exclusion Criteria:
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History of therapeutic radiation to the cranium
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Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients
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History of malignant disease
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Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period
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Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period
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Use of lutein >10 mg per day or zeaxanthin >2 mg per day within 1 month before Visit 1a, or planned use during the study period
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Any medical condition (including mental), in the opinion of the Investigator, that could interfere with study assessments, patient adherence to the study schedule, or interpretation of study data
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Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation
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Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline
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Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP) or if a sexual partner of a WOCBP
Plan de estudios
¿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: GAL-101 ophthalmic solution
Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval |
Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval |
|
Comparador de placebos: Placebo
Patient will apply daily 2 eye drops ofPlacebo at 5 minutes interval |
Patient will apply daily 2 eye drops of Placebo at 5 minutes interval |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size.
Periodo de tiempo: From baseline to last on-treatment visit (48 up to 96 weeks)
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Comparison between groups of annual rate of change in the area of GA as measured by fundus autofluorescence (FAF). |
From baseline to last on-treatment visit (48 up to 96 weeks)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in photoreceptor degeneration (PRD) in eyes with GA
Periodo de tiempo: From baseline to last on-treatment visit (48 up to 96 weeks)
|
Comparison between groups of annual rate of change in the area of PRD as measured by optical coherence tomography (OCT) |
From baseline to last on-treatment visit (48 up to 96 weeks)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GAL-101-C0201
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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