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NCT03063021 · ClinicalTrials.gov registry record · Phase 1
The FIGHT-RP1 Study
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03063021: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT03063021 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03063021, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
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. 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. 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. There is good rationale to test the effect of NAC in patients with RP. The first step is to test different dosing regimens to identify the lowest dose that is able to restore aqueous GSH/GSSG ratio and reduce carbonyl adducts on aqueous proteins. In patients with Idiopathic Pulmonary Fibrosis, polymorphisms within the TOLLIP gene were found to influence outcomes of NAC-treated patients. The product of the TOLLIP gene, toll-interacting protein, is an inhibitory adaptor protein downstream of toll-like receptors, mediators of innate and adaptive immunity. The identification of the influence of TOLLIP polymorphisms on the effect of NAC in Idiopathic Pulmonary Fibrosis provides the rationale for collecting DNA and genotyping the same single nucleotide polymorphisms (SNPs) in th
Interventions
- DRUG N-Acetyl Cysteine (NAC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-02-15 |
| Est. Completion | 2019-02-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03063021
The ClinicalTrials.gov registry entry for NCT03063021 describes a study currently listed as completed, 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. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which N-Acetyl Cysteine (NAC) is the first listed.
NCT03063021 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03063021 about?
NCT03063021 is a clinical study titled "The FIGHT-RP1 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. 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 ...
What is the current status of trial NCT03063021?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2017-02-15. Estimated completion is 2019-02-11.
What interventions are being tested in trial NCT03063021?
The interventions under investigation include: N-Acetyl Cysteine (NAC) (DRUG).
Who is sponsoring clinical trial NCT03063021?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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