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Antioxidant
N-acetylcysteine for Retinitis Pigmentosa (NAC Attack Trial)
Phase 3
Recruiting
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4.5 months, 9 months, 18 months, 27 months, 36 months, 40.5 months, 45 months
Awards & highlights
NAC Attack Trial Summary
This trial will test if N-acetylcysteine can help treat retinitis pigmentosa, an inherited retinal degeneration caused by mutations.
Who is the study for?
Adults aged 18-65 with Retinitis Pigmentosa (RP), willing to consent and follow the study protocol, not taking supplements other than vitamin A, and using contraception if of childbearing potential. Excluded are those with uncontrolled blood pressure, recent participation in another drug/device trial, certain genetic disorders like phenylketonuria or fructose intolerance, active cancer within a year (with exceptions), eye conditions that could affect results, severe myopia over -8 diopters, liver disease, cystic fibrosis, asthma/COPD or renal failure.Check my eligibility
What is being tested?
The clinical trial is testing whether long-term use of N-acetylcysteine (NAC) can slow down cone degeneration in patients with RP by reducing oxidative stress. Participants will either receive NAC or a placebo for several years across multiple locations internationally.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed here, common side effects of N-acetylcysteine may include nausea, vomiting, rash and fever. Allergic reactions are possible but rare.
NAC Attack Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4.5 months, 9 months, 18 months, 27 months, 36 months, 40.5 months, 45 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4.5 months, 9 months, 18 months, 27 months, 36 months, 40.5 months, 45 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progressive change of ellipsoid zone (EZ) width
Secondary outcome measures
Change in best-corrected visual acuity
Change in mean macular sensitivity measured by microperimetry (MP)
Other outcome measures
Change in BCVA
Change in cone reflectivity measured by AOSLO
Change in cone regularity measured by AOSLO
+7 moreNAC Attack Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1 - N-acetylcysteineExperimental Treatment1 Intervention
This is the intervention group. Patients in this group will be receiving 1800 mg of N-acetylcysteine in the form of 3 effervescent 600 mg tablets dissolved in water twice a day for 45 months.
Group II: Group 2 - PlaceboPlacebo Group1 Intervention
Patients in the placebo group will receive identical effervescent tablets lacking active drug.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-acetylcysteine
2008
Completed Phase 4
~1290
Find a Location
Who is running the clinical trial?
McGill UniversityOTHER
395 Previous Clinical Trials
998,939 Total Patients Enrolled
Northwestern UniversityOTHER
1,586 Previous Clinical Trials
916,813 Total Patients Enrolled
Medical University of GrazOTHER
493 Previous Clinical Trials
9,330,276 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is not under control.Both of my eyes are affected by RP, losing night vision and field of view but still see clearly.My eyes meet the study's health requirements.I have a history of liver disease, cystic fibrosis, asthma, COPD, low platelet count, or other blood disorders.I am receiving treatment for kidney failure.This is a general criterion which means it applies to all potential participants. There are no specific restrictions or requirements for this criterion.I have not had a stroke or heart attack recently.I do not have conditions that prevent me from taking NAC orally.I am allergic to or have recently used NAC.I am infected with HIV or hepatitis B.I am between 18 and 65 years old.I have had active cancer in the last year, except for certain types.I have eye conditions other than RP, including glaucoma or myopia.My eye meets the vision and scan criteria for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 - N-acetylcysteine
- Group 2: Group 2 - Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Retinitis Pigmentosa Patient Testimony for trial: Trial Name: NCT05537220 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could this treatment work for individuals over the age of 25?
"The age range for patients that this trial is looking to recruit are those that are between 18 to 65 years old."
Answered by AI
In how many different medical practices is this research project being conducted currently?
"There are 25 clinical sites running this trial, some notable locations include McGill University in Montreal, Wilmer Eye Institute in Baltimore, and University of California - Davis."
Answered by AI
Has N-acetylcysteine been cleared by the FDA?
"N-acetylcysteine has undergone multiple rounds of clinical testing, so it is estimated to be a safe medication with a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
California
Other
How old are they?
18 - 65
What site did they apply to?
University of Southern California, Keck School of Medicine
University of Washington, Department of Ophthalmology
University of Miami, Bascom Palmer Eye Institute
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
I have RP. trying to maintain sight I have. I would like to find a cure for my eyes.
PatientReceived 1 prior treatment
Want to maintain some vision till The End. I hope that the clinicaql trials can improve my vision..
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How does the process work? How long do screenings take?
How long is the trial?
PatientReceived 1 prior treatment
How long would I have to take this? Can I not get placebo? yes , How it will work ? and you reach which levels ? is there any hope for RO patients ?
PatientReceived 2+ prior treatments
How often would you have to come for testing? Does everyone receive the NAC or do some receive a placebo?
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Stanford University, Byers Eye Institute: < 48 hours
- University of Washington, Department of Ophthalmology: < 48 hours
- Retina Foundation of the Southwest: < 48 hours
Typically responds via
Phone Call
Email
Average response time
- < 2 Days
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