Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03999021 · ClinicalTrials.gov registry record · Phase 1
FIGHT-RP 1 Extension Study
A Phase 1 study of Retinitis Pigmentosa, sponsored by Johns Hopkins University.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03999021 is a Phase 1 study of Retinitis Pigmentosa that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 30 participants, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03999021, a Phase 1 study of Retinitis Pigmentosa, is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Retinitis Pigmentosa (RP) is a devastating eye disease and at present there are no known treatment options that can alter the rate of vision loss and eventual blindness. In a series of studies in animal models, the effects of exposing cones in the periphery of the retina to a large excess of oxygen results in progressive oxidative damage to cone photoreceptors and cone cell death. Cone cell death gradually spreads from the periphery of the retina toward its center, narrowing the visual field and eventually resulting in tunnel vision. Compared to control patients, those with RP showed significant reduction in the reduced to oxidized glutathione ratio (GSH/GSSG) in aqueous humor and a significant increase in protein carbonyl content. This demonstration of oxidative stress and oxidative damage in the eyes of patients with RP, suggests that oxidative damage-induced cone cell death in animal models of RP may translate to humans with RP and support the hypotheses that (1) potent antioxidants will promote cone survival and function in patients with RP and (2) aqueous GSH/GSSG ratio and carbonyl content on proteins provide useful biomarkers of disease activity in this patient population. Orally administered N-acetylcysteine (NAC) has been found to be a particularly effective antioxidant that promotes prolonged cone survival and maintenance of cone function in a mouse model of RP. Since oral and/or topical administration of NAC is feasible for long-term treatment in humans, and NAC has a good safety profile, there is good rationale to test the effect of NAC in patients with RP. Oxidative damage has been implicated in several diseases including cystic fibrosis, chronic obstructive pulmonary disease (COPD), and Idiopathic Pulmonary Fibrosis. The effect of oral NAC has been tested in these indications in several clinical trials providing extensive safety data. In COPD, NAC 600mg bid improves airway function and reduces the frequency of acute exacerbations. Doses of up to 1800m
Conditions Studied
Interventions
- DRUG NAC effervescent tablets
Study Locations (1)
Maryland
- Wilmer Eye Institute at Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03999021
The ClinicalTrials.gov registry entry for NCT03999021 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (89% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Retinitis Pigmentosa appearing as the primary indexed condition, and to 1 intervention - of which NAC effervescent tablets is the first listed.
NCT03999021 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03999021 about?
NCT03999021 is a clinical study titled "FIGHT-RP 1 Extension Study". Retinitis Pigmentosa (RP) is a devastating eye disease and at present there are no known treatment options that can alter the rate of vision loss and eventual blindness. In a series of studies in animal models, the effects of exposing cones in the periphery of the retina to a large excess of oxygen ...
What is the current status of trial NCT03999021?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-06-24. Estimated completion is 2027-06.
What conditions does trial NCT03999021 study?
This clinical trial studies the following conditions: Retinitis Pigmentosa.
What interventions are being tested in trial NCT03999021?
The interventions under investigation include: NAC effervescent tablets (DRUG).
Who is sponsoring clinical trial NCT03999021?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03999021 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Retinitis Pigmentosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Promising ROd-cone DYstrophy Gene therapY
RECRUITING · Phase 1
-
A Study to Investigate the Safety of DSP-3077 After a Unilateral Eye Injection in Male and Female Participants 18 Years of Age or Older With Retinitis Pigmentosa
RECRUITING · Phase 1
-
BS01 in Patients With Retinitis Pigmentosa
RECRUITING · Phase 1
-
The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration
RECRUITING · Phase 1
-
Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
ACTIVE NOT RECRUITING · Phase 1
-
Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa or Choroideremia Patients (ENVISION)
ACTIVE NOT RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.