NT101-AMD-001 (Age-Related Macular Degeneration)

Purpose of this Study

We are doing this study to find out if an experimental drug called NT-101 (the study drug) is a safe and effective option for people with wet age-related macular degeneration (AMD). The study drug is a topical solution that is administered directly to the eye (eye drops).

Who Can Participate?

Eligibility

Adults ages 50+ who:
  • Are diagnosed with wet AMD
  • Do not have diabetes
  • Do not have high blood pressure that is not controlled with medication
For more information about this study, contact the study team at DEC-RA@duke.edu.

Age Range

50-110

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 a random assignment (like a coin flip) to 1 of 2 groups:
  • You will either get a 0.05 mM dose of the study drug; OR
  • You will get a 0.2 mM dose of the study drug
You will take the study drug twice each day for a period of 4 weeks. Overall, participation in the study will last for about 8 weeks and will involve approximately 6 visits to the study clinic for exams and testing.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

A Randomized, Open-Label, Parallel-group, Multicenter Phase 1/2 Study to Evaluate the Safety and Exploratory Efficacy of NT-101 Topical Ophthalmic Solution in Patients with Wet Age-Related Macular Degeneration (AMD) - NT101-AMD-001

Principal Investigator

Lejla
Vajzovic

Protocol Number

PRO00116968

NCT ID

NCT06704009

Phase

I/II

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov