Resumen

Este es un estudio de extensión de fase 3, abierto y multicéntrico, para evaluar la seguridad y eficacia a largo plazo de pegcetacoplan (APL-2) en sujetos con atrofia geográfica (AG) secundaria a degeneración macular relacionada con la edad (DMRE) que participaron en el Estudio APL2-103 (NCT03777332) o completaron el tratamiento en el Mes 24 del Estudio APL2-303 (Derby, NCT03525613) o del Estudio APL2-304 (Oaks, NCT03525600).

Elegibilidad

Edad mínima: 60 YearsSexo: ALL

Criterios de inclusión

Participants are eligible to be included in the study only if all of the following criteria apply:
Subjects must have participated in APL2-103 (NCT03777332) or completed the treatment at Month 24 of either APL2-303 (Derby, NCT03525613) or APL2-304 (Oaks, NCT03525600).
For subjects who participated in either the 303 or 304 studies, the condition listed below must also be met for participating in this study.
Subjects who did not fully stop study drug treatment, but missed the visit at Month 24, can also participate in the study. However, to participate, subjects must be seen within 60 days from the last day of the period allowed for the 24 months visit in the previous study.
The eyes of subjects must have transparency to permit visualization of parts inside the eye such as the retina and subjects must be able to look steadily at a provided target allowing the doctor to get good quality pictures from the eye.
Female subjects must be:
Women that cannot have children, or
Women who can have children must have a negative result of a blood pregnancy test on the first day of the study visit and agree to use ways to avoid pregnancy during the study and 90 days after the last dose of the study medication.
Males with female partners who can get pregnant must also agree to use ways to avoid pregnancy and agree not to donate sperm while in the study or until 90 days after administering the last dose of the study medication.
Agree to participate in the study by signing the consent document providing information about the study; and take part in all tests and assessments as required.

Criterios de exclusión

Subjects cannot take part in the study if the eye that will be treated during the study currently meets any of the following conditions:
Participants in APL2 303/304 studies who fully stopped study drug treatment before the visit in month 24 but remain in the study to observe the study medication's safety. Those subjects who temporarily paused study drug treatment are still eligible to participate.
If, according to your doctor you currently have any disease affecting your eyes that could interfere with your vision, including diseases that affect your retina or macula (the center of the back of your eyes). And, if according to your doctor, the disease in your eyes is benign and does not interfere with the study (e.g. diseases that affects the periphery of the retina), you are also eligible to take part in the study.
If, according to your doctor you currently have any inflammation/infection in or around your eyes that could prohibit you from receiving an injection inside your eyes.
If, according to your doctor, any current disease that could directly interfere in your participation in the study or that could make it difficult for you to come to the scheduled visits during the next three yearsover the next 36 months.
If you have known allergies to fluorescein sodium, a solution that is injected into your body for eye testing; or to pegcetacoplan (the study drug) or any inactive substances in pegcetacoplan solution.
If you currently are pregnant, breastfeed or have a positive pregnancy test.

Ubicaciones

Diagnostico Ocular

Buenos Aires, Argentina

Organizacion Medica de Investigacion (OMI)

Buenos Aires, Argentina

Fundacion Zambrano

Buenos Aires, Argentina

Centro Oftalmologico Dr. Charles S.A.

Buenos Aires, Argentina

Instituto Oftalmologico de Cordoba

Córdoba, Argentina

OFTAR

Mendoza, Argentina

Microcirujia Ocular Rosario

Rosario, Argentina

Oftalmologos Especialistas

Santa Fe, Argentina

Estudio de extensión de Fase 3, abierto, multicéntrico, para evaluar la seguridad y eficacia a largo plazo de pegcetacoplan en sujetos con atrofia geográfica secundaria a degeneración macular relacionada con la edad

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

PEGCETACOPLAN (APL-2)

Ubicaciones

Diagnostico Ocular

Organizacion Medica de Investigacion (OMI)

Fundacion Zambrano

Centro Oftalmologico Dr. Charles S.A.

Instituto Oftalmologico de Cordoba

OFTAR

Microcirujia Ocular Rosario

Oftalmologos Especialistas

Patrocinadores