Purpose of this Study
If people join this study, they will first have tests to see if they can take part. If they qualify, they will be placed into one of two groups by chance. Most participants will receive a new medicine called OCS 05, while a smaller number will receive a placebo, which has no active medicine. Neither the participants nor the study doctors will know which treatment is being given.
Everyone in the study will receive the standard treatment for optic neuritis, which is a steroid medicine given through a vein. In addition, participants will receive either OCS 05 or the placebo through a vein once a day for five doses.
The study lasts about one year. During that time, participants will have regular visits for eye exams, vision tests, brain scans, neurological exams, and safety checks. Researchers want to learn if OCS 05 is safe and if it can help protect vision and improve recovery in people with optic neuritis.
Who Can Participate?
Eligibility
People may be able to join this study if they are 18 to 50 years old and are having their first episode of optic neuritis in one eye. They must have vision loss that started within the past 12 days and meets the study requirements. An MRI scan must show signs of optic neuritis affecting the eye and optic nerve. Participants must also be able to understand the study and give permission to take part.
Age Range
18-50
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a new medicine called OCS 05 for people who have optic neuritis, a condition that causes swelling of the optic nerve and can affect vision. Researchers want to learn if adding OCS 05 to the standard treatment can help people recover better and protect their vision.
Everyone in the study will receive the usual treatment for optic neuritis. Some participants will also receive OCS 05, while others will receive a placebo, which has no active medicine. Researchers will compare the two groups to see how well OCS 05 works and to monitor for any side effects. The goal is to find out if OCS 05 can improve recovery and become a useful treatment for people with optic neuritis.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research - (PIONEER-1)
Principal Investigator
Can
Kocasarac
Protocol Number
PRO00120999
NCT ID
NCT07623668
Phase
III
Enrollment Status
Pending Open to Enrollment