Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration (JOURNEY)
Estudio de fase 1/2a de aumento de dosis de VOY-101 en pacientes con degeneración macular avanzada no neovascular relacionada con la edad
The Phase 1 safety study of VOY-101 is comprised of escalating dose Cohorts, followed by a Phase 2 at the recommended phase 2 dose.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study has a prospective, open-label, multi-center, two-part design to evaluate a single, unilateral intravitreal (IVT) injection of VOY-101 in subjects with geographic atrophy (GA), the advanced form of non-neovascular age-related macular degeneration (AMD). Phase 1 followed a standard dose escalation model to establish safety and tolerability of VOY-101 and determine the recommended phase 2 dose. This dose is being used in the randomized Phase 2 part of the study to evaluate the safety and efficacy of VOY-101 in the study eye compared to untreated fellow eye.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2000
- Sydney Retina Clinic and Day Surgery
-
-
Victoria
-
East Melbourne, Victoria, Australia, 3002
- Cerulea Clinical Trials
-
-
-
-
Arizona
-
Scottsdale, Arizona, Estados Unidos, 85255
- Retina Macula Institute of AZ
-
-
California
-
Poway, California, Estados Unidos, 92064
- Retina Consultants San Diego
-
Sacramento, California, Estados Unidos, 95825
- Retinal Consultants Medical Group
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Ophthalmic Consultants of Boston
-
-
Missouri
-
St Louis, Missouri, Estados Unidos, 63128
- The Retina Institute
-
-
New Jersey
-
Cherry Hill, New Jersey, Estados Unidos, 08034
- Mid Atlantic Retina
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97221
- Retina Northwest
-
-
South Dakota
-
Rapid City, South Dakota, Estados Unidos, 57701
- Black Hills Regional Eye Institute
-
-
Texas
-
Austin, Texas, Estados Unidos, 78705
- Austin Research Center for Retina
-
Fort Worth, Texas, Estados Unidos, 76132
- Star Retina
-
Southlake, Texas, Estados Unidos, 76092
- Retina Center of Texas
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84132
- University of Utah John A. Moran Eye Center
-
-
-
-
-
Haifa, Israel
- Rambam Medical Center
-
Tel Aviv, Israel, 64239
- Tel-Aviv Sourasky Medical Center, Ophthalmology Division
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Are ≥60 years of age at the time of consent.
- Are willing and able to understand and provide written informed consent.
- Are willing and able to return for scheduled treatment and follow-up examinations.
- Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.
- Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV for both eyes.
- Absence of signs of non-exudative MNV.
- Additional Ocular Inclusion Criteria for both eyes.
- Meet certain genotype criteria for risk of AMD.
Exclusion Criteria:
- Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study.
- Additional Systemic, Ocular, and Genetic Exclusion Criteria.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Low
Single, unilateral, intravitreal injection of low dose of VOY-101 |
VOY-101 |
|
Experimental: Medium
Single, unilateral, intravitreal injection of medium dose of VOY-101 |
VOY-101 |
|
Experimental: High
Single, unilateral, intravitreal injection of high dose of VOY-101 |
VOY-101 |
|
Experimental: Higher
Single, unilateral, intravitreal injection of higher dose of VOY-101 |
VOY-101 |
|
Experimental: Intermediate
Single, unilateral, intravitreal injection of intermediate dose of VOY-101 |
VOY-101 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Phase 1: To evaluate the safety and tolerability of a single intravitreal injection of escalating doses of VOY-101
Periodo de tiempo: 24 Months
|
Frequency and type of ocular and systemic adverse events and non-serious treatment-emergent adverse events |
24 Months
|
|
Phase 1: Change from Baseline in markers of inflammation
Periodo de tiempo: Baseline to Month 24
|
Change from Baseline in markers of inflammation including anterior chamber cells, vitreous cells, and retinal vasculitis and retinitis. |
Baseline to Month 24
|
|
Phase 1: Establish the recommended Phase 2 dose in subjects with Geographic Atrophy.
Periodo de tiempo: Month 12
|
Determine whether the maximum tolerated dose (MTD) has been reached (as determined by the occurrence of dose-limiting toxicities [DLTs]) and select the RP2D. |
Month 12
|
|
Phase 2: To evaluate the effect of VOY-101 in the study eye compared with untreated fellow eye on change in Geographic Atrophy lesion size.
Periodo de tiempo: 15 Months
|
Change from Baseline in Geographic Atrophy lesion size |
15 Months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Phase 1: To evaluate the effect of VOY-101 on geographic atrophy lesion size and photoreceptors
Periodo de tiempo: Baseline through 24 Months
|
Growth rate of total geographic atrophy lesion size and photoreceptor change |
Baseline through 24 Months
|
|
Phase 1/2: To establish the pharmacokinetic (PK) profile of VOY-101.
Periodo de tiempo: Baseline through 24 Months
|
Change from Baseline for complement levels in aqueous humor |
Baseline through 24 Months
|
|
Phase 1/2: To evaluate the effect of VOY-101 on best corrected distance visual acuity
Periodo de tiempo: 24 Months
|
Change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCDVA and Percentage of subjects with <15 letters lost in BCDVA from Treatment |
24 Months
|
|
Phase 1/2: Development of macular neovascularization
Periodo de tiempo: Month 24
|
Incidence, frequency, severity, and timing of development of macular neovascularization |
Month 24
|
|
Phase 2: To further characterize the ocular and systemic safety and tolerability of VOY-101
Periodo de tiempo: 24 Months
|
Frequency of Investigational Product related ocular and systemic adverse events, adverse events of special interest and non-serious treatment-emergent adverse events. |
24 Months
|
|
Phase 2: To evaluate the effect of VOY-101 in the study eye compared with untreated fellow eye on geographic atrophy lesion size and photoreceptors
Periodo de tiempo: Baseline through Month 24
|
Change in geographic atrophy lesion size and rate of photoreceptor loss |
Baseline through Month 24
|
|
Phase 2: To evaluate the effect of VOY-101 on low luminance visual acuity
Periodo de tiempo: Baseline through Month 24
|
Change from Baseline in the change in visual function using Early Treatment Diabetic Retinopathy Study (ETDRS) Low Luminance Visual (LLVA) vision test |
Baseline through Month 24
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Anne Fung, MD, Perceive Biotherapeutics, Inc.
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PBI-AMD-002
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.
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. .