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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: Active Phase 1 study of Retinitis Pigmentosa, sponsored by Johns Hopkins University.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Blood pressure in mmHg will be used in assessing tolerability of N-Acetylcysteine.
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 |
What the registry record for NCT03999021 still lists
NCT03999021 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 261-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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
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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.
Where NCT03999021's enrollment target sits among peer trials
30 21st of 37 higher than 16 of 37 other Retinitis Pigmentosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Retinitis Pigmentosa 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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