This study is a Phase IV multicenter, open-label (BCVA assessor-masked) study designed to assess the response to treatment with SUSVIMO every 24 weeks in patients with Neovascular Age-Related Macular Degeneration (nAMD) who have been previously treated with anti-VEGF agents other than ranibizumab.
Belvedere
A Phase IV, Multicenter, Open-label, Single-Arm study of the response to treatment after transition to the port delivery system with Ranibizumab (Susvimotom [Ranibizumab injection]) in patients with neovascular age-related macular degeneration previously treated with intravitreal agents other than Ranibizumab.
Macular degeneration
All genders
50+
Recruiting now
Overview
Principal Investigator: Caroline Baumal, MD
Contact Us
Nancy Gee
Study details
Inclusion Criteria
- Initial diagnosis of nAMD within 6 to 18 months prior to screening
- Previous treatment with at least 3 anti-VEGF injections (other than ranibizumab) for nAMD per standard of care within 9 months prior to Day 1 (SUSVIMO implantation); the most recent anti-VEGF injection must have occurred within 12 weeks of PDS implantation
- The last 2 anti-VEGF injections for nAMD prior to screening must be with either bevacizumab or aflibercept
Exclusion Criteria
- Prior vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
- Prior treatment with ranibizumab
- Previous intraocular device implantation excluding intraocular lenses
Study Requirements
This study will last approximately 1 year. It will begin with a Screening Visit at least 7 days after your last anti-VEGF ITV, followed by an Enrollment Visit within the next 28 days, and then the official Day 1 of the study is marked by the SUSVIMO implant insertion. Following implantation, there will be 10 scheduled in-person study visits and 5 tele-ophthalmology visits in between occurring approximately every 4 weeks. During the in-person visits subjects will standardly undergo BCVA, Slit lamp examination, Dilated binocular indirect ophthalmoscopy, Anterior segment OCT imaging, SD-OCT imaging and a Digital photo. The tele-ophthalmology visits will only consist of a guided patient interview and Digital photo. Specifically at weeks 24 and 48 there will be an implant refill exchange. The only required blood work for this study are three tubes for Hematology, Chemistry and Coagulation to be drawn at the Screening Visit alone.