Medical College of Wisconsin Ophthalmology and Visual Sciences Research Study - NAC Attack, A Phase III, Multicenter, Randomized, Parallel, Double Masked, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral N-Acetylcysteine in Patients with Retinitis Pigmentosa

Purpose of study:
This study is being funded by the National Eye Institute to determine if N-Acetylcysteine, an antioxidant supplement, taken twice a day in patients with Retinitis Pigmentosa can reduce loss of cone photoreceptors and delay vision loss over a span of 45 months. It will also determine if there are side effects from long-term use of NAC.

What retinal conditions are we looking for?
Retinitis Pigmentosa (RP) is an eye disease that causes loss of side (peripheral) vision that often progresses to tunnel vision and blindness. RP is caused by genetic mistakes (or mutations) that cause the death of light-sensing cells in the retina.

What is involved?
Participation in this study involves taking study drug two times per day and allowing the study team to monitor eye health with eye and vision exams, taking pictures of the retina, and collecting vital signs, blood samples, and health information. This requires a total of 9 in-clinic visits (including the screening visit), 3 virtual visits with your study doctor, and 10 phone calls with a study coordinator over a span of approximately 45 months (almost 4 years).

Compensation:
Reimbursement for travel to and from the study site and study visit related lodging will be provided to you as approved by your study site, but you will not receive a stipend for participating in this research study, except that an optional stipend for Adaptive Optics imaging (AOSLO) substudy participation is available if it is relevant to you and your site.

You may be eligible to participate in this study if you meet these criteria:
1. You are between the ages of 18-65
2. You have a diagnosis of Retinitis Pigmentosa
3. You have a visual acuity of 20/60 or better
4. You have a refractive error (i.e., glasses/contact lens spherical equivalent correction) of no more than 8 diopters
5. You agree to not take supplements other than Vitamin A
6. You have not taken NAC (N-Acetylcysteine) in any form in the last 4 months
7. For female candidates of childbearing potential, you are willing to use a method of contraception

More information
Contact Katie McKenney with questions at (414) 955-7866 or kmckenney@mcw.edu.
PRO00044718
IRB approval date 08/27/2023

Research Volunteer Form

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By submitting this form, I acknowledge that I would like to be contacted about the NAC Attack project and understand that submission of this form in no way obligates me to participate in this study.

We appreciate your interest in our study and will contact you as soon as we can. Thank you for your patience.

If you have questions, please contact Katie McKenney at (414) 955-7866.