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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Both eyes must exhibit the RP phenotype with evidence of loss of night vision, gradual constriction of visual fields, and maintenance of visual acuity
In addition, an eye must meet the following criteria to be included in the study: Gradable EZ on a horizontal SD-OCT scan through the fovea center with width ≤ 8000 µm and ≥1500 µm and with well-defined truncation at both the nasal and temporal sides
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline, 4.5 months, 9 months, 18 months, 27 months, 36 months, 40.5 months, 45 months
Awards & highlights
Pivotal Trial
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 belowSelect...
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 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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had laser treatment for a certain eye condition in the past.You have an eye condition that could make it difficult to understand the study results.You have had a previous condition called uveitis in one or both of your eyes.This is a general criterion which means it applies to all potential participants. There are no specific restrictions or requirements for this criterion.You cannot take any supplements except for vitamin A.You have other health conditions or test results that suggest taking oral NAC might not be safe or it could affect your follow-up care.You have had a stroke or heart attack within the past 6 months.You have had an allergic reaction to NAC in the past.You have taken NAC (a medication) in any form within the last 4 months.You have glaucoma or another eye condition that affects your ability to see clearly.You have any eye disease other than retinitis pigmentosa that affects your ability to see clearly or have a limited field of vision.You have had eye surgery within the past 3 months.You are able to comply with the study protocol and to participate in all study visits and assessments in the investigator's judgement.You have liver disease, cystic fibrosis, asthma, or a lung condition called COPD. You also have a history of low platelet count or other blood problems that are not reversible.You have severe kidney problems and need dialysis or a kidney transplant.Criteria related to eyes that determine whether you can participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 - Placebo
- Group 2: Group 1 - N-acetylcysteine
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?
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:
- Stanford University, Byers Eye Institute: < 48 hours
- University of Washington, Department of Ophthalmology: < 48 hours
- Retina Foundation of the Southwest: < 48 hours
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