Age-related Macular Degeneration // Clinical Trials // Mihai Mititelu // Ongoing // Oct 07 2022
A Phase III, 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)
Sponsor: Apellis Pharmaceuticals, Inc.
Principal Investigator: Mihai Mititelu, MD, MPH
Study Coordinator: Chris Smith
To assess the long-term efficacy and safety of multiple intravitreal injections of APL-2 in subjects with geographic atrophy secondary to age-related macular degeneration.
This is a prospective, multicenter, open-label pivotal study. Participants will undergo cataract surgery and IMT implantation after screening and complete 5 study visits in approximately 12-15 months.
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.
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 inflammation/infection in or around your eyes that could prohibit you from receiving an injection inside your eyes.
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.