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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
Must not have
Patients with a concomitant ocular pathology that limits central macular function, including but not limited to: age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion
Patients with uncontrolled hypertension (defined as diastolic blood pressure > 95 mm Hg or systolic blood pressure > 160 mm Hg despite medical therapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial is testing N-acetylcysteine (NAC) tablets to help people with Retinitis Pigmentosa (RP), a disease that causes vision loss. NAC is an antioxidant that protects eye cells from damage. The goal is to see if NAC can slow down or stop the progression of vision loss in RP patients.
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.
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.
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 belowSelect...
I have been diagnosed with retinitis pigmentosa.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an eye condition affecting the center of my vision.
Select...
My blood pressure is not controlled even with medication.
Select...
I currently have an eye infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Change in aqueous reduced to oxidized glutathione ratio (GSH/GSSG)
Change in best corrected visual acuity (BCVA)
Change in central retinal sensitivity as assessed by microperimetry
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment1 Intervention
All participants to receive study intervention.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Retinitis Pigmentosa (RP) is characterized by progressive loss of photoreceptors, primarily due to oxidative stress. Antioxidants like N-acetylcysteine (NAC) play a crucial role in reducing oxidative damage to cone photoreceptors, thereby promoting their survival and function.
NAC works by replenishing intracellular glutathione levels, a key antioxidant that neutralizes reactive oxygen species (ROS) and reduces oxidative stress. This mechanism is particularly important for RP patients as it helps slow the progression of vision loss and maintains visual function.
Other treatments, such as gene therapy, aim to correct genetic defects, but antioxidants like NAC offer a more immediate approach to managing oxidative damage in RP.
Efficacy of various antioxidants in the protection of the retinal pigment epithelium from oxidative stress.
Efficacy of various antioxidants in the protection of the retinal pigment epithelium from oxidative stress.
Find a Location
Who is running the clinical trial?
Zambon SpAIndustry Sponsor
30 Previous Clinical Trials
6,278 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,317 Previous Clinical Trials
14,871,919 Total Patients Enrolled
9 Trials studying Retinitis Pigmentosa
881 Patients Enrolled for Retinitis Pigmentosa
Peter CampochiaroPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an eye condition affecting the center of my vision.I have been diagnosed with retinitis pigmentosa.My blood pressure is not controlled even with medication.I am 18 years old or older.I currently have an eye infection.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: NCT03999021 — Phase 1
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