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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). 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
Primary Outcome
Assessment of safety and tolerability of N-Acetylcysteine including incidence and severity of systemic and ocular adverse events (AEs) and changes from baseline vital signs and physical examination.
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 |
What the finished NCT03063021 record still lists
NCT03063021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which N-Acetyl Cysteine (NAC) is the first listed.
NCT03063021 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03063021's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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