Purpose of this Study
We are doing this study to find out if an experimental drug called ADX-2191 (the study drug) is a safe and effective option for people with retinitis pigmentosa (RP) due to confirmed rhodopsin mutations.
Who Can Participate?
Eligibility
Adults ages 21+ who:
- Are diagnosed with RP
- Have rhodopsin mutations
Age Range
21-110
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 this study, you will get a random assignment (like a coin flip) to receive either a high or low dose of the study drug. You will get the study drug as an intravitreal (into the eye) injection once a month for 12 months.
Participation in the study lasts about 13 months and involves 15 visits to our clinic.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Randomized, Double-Masked, Controlled, Parallel-Group, Multicenter, Phase?2/3 Clinical Trial Investigating the Efficacy and Safety of ADX-2191 in Adults with Retinitis Pigmentosa - ADX-2191-RP-002
Principal Investigator
Ramiro
Maldonado
Protocol Number
PRO00116182
Phase
II/III
Enrollment Status
Pending Open to Enrollment