{ "data": { "asOf": "2026-10-30T22:24:25.499Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT03999021", "title": "FIGHT-RP 1 Extension Study", "scientificTitle": "A Phase 1 Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of N-Acetylcysteine (NAC) in Patients With Retinitis Pigmentosa", "status": "active", "studyType": "interventional", "phase": [ "PHASE1" ], "conditions": [ "Retinitis Pigmentosa" ], "interventions": [ { "name": "NAC effervescent tablets", "type": "DRUG", "description": "After completing the pretreatment visits, all patients will enter into the treatment phase where patients will receive 1800 mg of NAC effervescent tablets twice a day. The patients will be followed up every 3 months for 2 years. Therefore, there will be a total of 9 treatment visits (baseline, months 3, 6, 9, 12, 15, 18, 21 and 24)." } ], "sponsor": { "name": "Johns Hopkins University", "type": "OTHER" }, "locations": [ { "city": "Baltimore", "country": "United States", "facility": "Wilmer Eye Institute at Johns Hopkins University" } ], "outcomes": { "other": [], "primary": [ "Blood Pressure (mmHg)", "Tolerability of N-Acetylcysteine as assessed by drug-related symptoms", "Tolerability of N-Acetylcysteine as assessed by time at which medication is taken", "Tolerability of N-Acetylcysteine as assessed by number of times medication is taken per day" ], "secondary": [ "Change in best corrected visual acuity (BCVA)", "Change in central retinal sensitivity as assessed by microperimetry", "Change in ellipsoid zone (EZ) width (µm)", "Change in aqueous reduced to oxidized glutathione ratio (GSH/GSSG)", "Change in serum carbonyl content (nmol/mg)", "Change in aqueous levels of N-Acetylcysteine (mg)", "Change in plasma levels of N-Acetylcysteine (µg/ml)" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Age 18 years\n* Patients diagnosed with RP\n* Informed consent\n* Authorization of use and disclosure of protected health information\n\nExclusion Criteria:\n\n* 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\n* Patients with an active ocular infection\n* Patients with uncontrolled hypertension (defined as diastolic blood pressure \\> 95 mm Hg or systolic blood pressure \\> 160 mm Hg despite medical therapy)", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 30 }, "startDate": "2019-06-24", "completionDate": "2030-06-01", "lastUpdated": "2026-08-07T00:00:00.000Z", "firstPosted": "2019-06-26T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT03999021" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT03999021", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT03999021", "sourceUrl": "https://clinicaltrials.gov/study/NCT03999021", "sourceStatus": "ACTIVE_NOT_RECRUITING", "retrievedAt": "2026-10-07T04:31:05.166Z", "payloadSha256": "668cff3a8de34c9ccfb41fe319c02039823665780bfb9e378c514f76e0060917", "piiRedacted": true } ], "citation": { "canonicalId": "NCT03999021", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT03999021", "verifyAt": "https://clinicaltrials.gov/study/NCT03999021", "retrievedAt": "2026-10-07T04:31:05.166Z", "payloadSha256": "668cff3a8de34c9ccfb41fe319c02039823665780bfb9e378c514f76e0060917", "text": "ClinicalTrials.gov, record NCT03999021 (https://clinicaltrials.gov/study/NCT03999021), retrieved 2026-10-07, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT03999021, registered in ClinicalTrials.gov, retrieved 2026-10-07. 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