Informations générales (source: ClinicalTrials.gov)
A Phase 3, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALE)
Interventional
Phase 3
Apellis Pharmaceuticals, Inc. (Voir sur ClinicalTrials)
mars 2021
septembre 2025
27 juin 2024
This is a phase 3, open-label, multicenter, extension study to evaluate the long-term
safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy (GA)
secondary to age-related macular degeneration (AMD) who participated in Study APL2-103
(NCT03777332) or completed the treatment at Month 24 of either Study APL2-303 (Derby,
NCT03525613) or Study APL2-304 (Oaks, NCT03525600).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Eric SOUIED | 29/05/2024 12:17:11 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | Contact (sur clinicalTrials) | ||||
| CHNO DES QUINZE-VINGTS PARIS | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre monticelli Paradis - 13008 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Centre Ophtalmo. Image/Laser - 75015 - Paris - France | Contact (sur clinicalTrials) | ||||
| Centre Ophtalmol de l Odeon - 75006 - Paris - France | Contact (sur clinicalTrials) | ||||
| Centre ophtalmologique Saint-Exupery - 37540 - Saint-Cyr-sur-Loire - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHU de Bordeaux - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes - Hotel Dieu - 44093 - Nantes Cedex - France | Contact (sur clinicalTrials) | ||||
| CHU de Strasbourg Hopital Civil - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| CHU Dijon - 21 079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Clinique du Val d'Ouest - 69130 - Écully - France | Contact (sur clinicalTrials) | ||||
| Hopital de la Croix-Rousse - 69004 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Maison Rouge Ophthalmologic Center - 67000 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following
criteria apply:
Ocular-specific inclusion criteria apply to the study eye only.
- 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.
Participants are eligible to be included in the study only if all of the following
criteria apply:
Ocular-specific inclusion criteria apply to the study eye only.
- 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.
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.