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Antioxidant

N-acetylcysteine for Retinitis Pigmentosa

Phase 1
Waitlist Available
Led By Peter Campochiaro
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients diagnosed with RP
Age 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing if N-acetylcysteine, an antioxidant, can help treat Retinitis Pigmentosa, a disease which causes progressive vision loss and eventual blindness. So far, the maximum tolerated dose of NAC has been 1800mg twice a day.

Who is the study for?
This trial is for adults over 18 with Retinitis Pigmentosa (RP), a condition leading to vision loss. Participants must consent to use their health information and understand the study's details. It excludes those with other eye diseases affecting central vision, active eye infections, or uncontrolled high blood pressure.Check my eligibility
What is being tested?
The FIGHT-RP 1 Extension Study tests NAC effervescent tablets as a potential treatment for RP. The study builds on previous findings that suggest antioxidants like NAC could help preserve eyesight in RP by reducing oxidative damage in the retina.See study design
What are the potential side effects?
NAC may cause gastrointestinal issues such as vomiting, diarrhea, and abdominal pain. Less common are hypersensitivity reactions like anaphylactic shock or skin rashes. Other possible side effects include headache, tinnitus, fever, low blood pressure, facial swelling, and bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with retinitis pigmentosa.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Pressure (mmHg)
Tolerability of N-Acetylcysteine as assessed by drug-related symptoms
Tolerability of N-Acetylcysteine as assessed by number of times medication is taken per day
+1 more
Secondary outcome measures
Change in aqueous levels of N-Acetylcysteine (mg)
Change in aqueous reduced to oxidized glutathione ratio (GSH/GSSG)
Change in best corrected visual acuity (BCVA)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment1 Intervention
All participants to receive study intervention.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,267 Previous Clinical Trials
14,837,577 Total Patients Enrolled
9 Trials studying Retinitis Pigmentosa
882 Patients Enrolled for Retinitis Pigmentosa
Peter CampochiaroPrincipal InvestigatorJohns Hopkins University

Media Library

NAC effervescent tablets (Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT03999021 — Phase 1
Retinitis Pigmentosa Research Study Groups: Experimental Arm
Retinitis Pigmentosa Clinical Trial 2023: NAC effervescent tablets Highlights & Side Effects. Trial Name: NCT03999021 — Phase 1
NAC effervescent tablets (Antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03999021 — Phase 1
Retinitis Pigmentosa Patient Testimony for trial: Trial Name: NCT03999021 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical purposes are NAC effervescent tablets usually prescribed for?

"NAC effervescent tablets are commonly used as an intervention for corneal ulceration, but they can also be prescribed to treat acute rhinitis, acetaminophen toxicity and other corneal diseases."

Answered by AI

Are there any openings currently available for individuals to partake in the study?

"The clinicaltrials.gov website reveals that enrollment for this medical trial has been closed since September 15th 2022, after first being posted on June 24th 2019. However, there are currently 89 other trials seeking patient involvement at the present moment."

Answered by AI

How many participants are currently taking part in this medical experiment?

"Unfortunately, the study is no longer searching for new participants. It was initially posted on June 24th 2019 and last updated on September 15th 2022. Nonetheless, there are still 51 clinical trials looking to enroll those afflicted with retinitis pigmentosa and 38 studies actively recruiting patients who use NAC effervescent tablets."

Answered by AI

Are there additional research studies centering on NAC effervescent tablets?

"Presently, 38 clinical trials involving NAC effervescent tablets are running with 7 of them in the final phase 3. 44 sites across New york City have been approved to host these medical experiments."

Answered by AI

Is NAC effervescent tablets authorized by the Food and Drug Administration?

"Considering the preliminary nature of this Phase 1 trial, there is insufficient data to assess NAC effervescent tablets' safety profile. As a result, it received a score of 1 from our Power team's evaluation."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Pennsylvania
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Wilmer Eye Institute at Johns Hopkins University
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Because back in India there are no clinical trials or any treatment.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

When will this trial start?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
FIGHT-RP 1 Extension Study
2019. "FIGHT-RP 1 Extension Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03999021.
All > Retinitis Pigmentosa
~9 spots leftby Aug 2026
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