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Antioxidant

N-acetylcysteine for Retinitis Pigmentosa(NAC Attack Trial)

University of California - San Francisco, Department of Ophthalmology, San Francisco, CA
N-acetylcysteine +1 morePhase 3RecruitingResearch Sponsored by Johns Hopkins University

NAC Attack Trial Summary

This trial will test if N-acetylcysteine can help treat retinitis pigmentosa, an inherited retinal degeneration caused by mutations.

Eligible Conditions
  • Retinitis Pigmentosa

NAC Attack Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
This is a general criterion which means it applies to all potential participants. There are no specific restrictions or requirements for this criterion.
Select...
Criteria related to eyes that determine whether you can participate in the study.

NAC Attack Trial 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4.5 months, 9 months, 18 months, 27 months, 36 months, 40.5 months, 45 months for reporting.

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 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

NAC 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?

University of IowaOTHER
435 Previous Clinical Trials
869,865 Total Patients Enrolled
University College London HospitalsOTHER
184 Previous Clinical Trials
966,331 Total Patients Enrolled
University of AmsterdamOTHER
37 Previous Clinical Trials
20,955 Total Patients Enrolled

Media Library

N-acetylcysteine (Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT05537220 — Phase 3
Retinitis Pigmentosa Research Study Groups: Group 2 - Placebo, Group 1 - N-acetylcysteine
Retinitis Pigmentosa Clinical Trial 2023: N-acetylcysteine Highlights & Side Effects. Trial Name: NCT05537220 — Phase 3
N-acetylcysteine (Antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05537220 — Phase 3
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?
Stanford University, Byers Eye Institute
Vanderbilt University, Vanderbilt Eye Institute
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

What questions have other patients asked about this trial?

How does the process work? yes , How it will work ? and you reach which levels ? is there any hope for RO patients ?
PatientReceived no 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
Is there a clinicl trail anywhere that is recruiting now or will be in the near future that I might get in?
PatientReceived no prior treatments
How long would I be in Seattle? Can my husband accompany me during the trial? How, exactly, does this trial work?
PatientReceived no prior treatments

Why did patients apply to this trial?

I have RP. trying to maintain sight I have. Want to maintain some vision till The End.
PatientReceived no prior treatments
I hope that the clinicaql trials can improve my vision.. Desperately trying to find a clinical trial that could possibly help me retain my eyesight.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
  1. Stanford University, Byers Eye Institute: < 48 hours
  2. University of Washington, Department of Ophthalmology: < 48 hours
  3. Retina Foundation of the Southwest: < 48 hours
~292 spots leftby Dec 2028