Belvedere ML43000 (Neovascular Age-Related Macular Degeneration)

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:
  • 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 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?

Description

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.

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
ClinicalTrials.gov