Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.
Belvedere ML43000 (Neovascular Age-Related Macular Degeneration) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to monitor the health of the cornea in participants with neovascular age-related macular degeneration (nAMD), also know as wet AMD, who receive an eye implant that continuously delivers the drug ranibizumab into the back of the eye.
What is the Condition Being Studied?
Neovascular Age-Related Macular Degeneration (nAMD) AKA "Wet AMD"
Who Can Participate in the Study?
Adults ages 50+ who:
- Are diagnosed with nAMD (within 18 months of joining study)
- Have not received treatment with intravitreal corticosteroids
- Have not had an intraocular surgery (including cataract surgery) within 6 months of joining the study
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
Age Group
Adults
What is Involved?
If you choose to join the study, you will:
- Get an eye implant, filled with ranibizumab
- Be enrolled in the study for about 1 year
- Visit our clinic at the Duke Eye Center up to 13 times during the study
At various visits, you will have blood tests, eye exams, and vision tests.
Study Details
Full Title
A Phase IV, Multicenter, Open-label Study to Assess Corneal Endothelial Cells in Patients with Neovascular Age-related Macular Degeneration Treated with the Port Delivery System with Ranibizumab (PDS) – Belvedere ML43000
Principal Investigator
Ophthalmologist
Protocol Number
IRB:
PRO00115213
NCT:
NCT04853251
Phase
Phase
IV
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon