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.
Who Can Participate?
Eligibility
Adults ages 50+ who:<ul>
<li>Are diagnosed with nAMD (within 18 months of joining study)</li>
<li>Have not received treatment with intravitreal corticosteroids</li>
<li>Have not had an intraocular surgery (including cataract surgery) within 6 months of joining the study</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: DEC-RA@duke.edu">DEC-RA@duke.edu.</a>
<li>Are diagnosed with nAMD (within 18 months of joining study)</li>
<li>Have not received treatment with intravitreal corticosteroids</li>
<li>Have not had an intraocular surgery (including cataract surgery) within 6 months of joining the study</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: DEC-RA@duke.edu">DEC-RA@duke.edu.</a>
Age Range
55-89
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join the study, you will:<ul>
<li>Get an eye implant, filled with ranibizumab</li>
<li>Be enrolled in the study for about 1 year</li>
<li>Visit our clinic at the Duke Eye Center up to 13 times during the study</li></ul>
At various visits, you will have blood tests, eye exams, and vision tests.
<li>Get an eye implant, filled with ranibizumab</li>
<li>Be enrolled in the study for about 1 year</li>
<li>Visit our clinic at the Duke Eye Center up to 13 times during the study</li></ul>
At various visits, you will have blood tests, eye exams, and vision tests.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Lejla
Vajzovic
Protocol Number
PRO00115213
NCT ID
NCT04853251
Phase
IV
Enrollment Status
Pending Open to Enrollment