FIGHT-RP 1 Extension Study
Słowa kluczowe
Abstrakcyjny
Daktyle
Ostatnia weryfikacja: | 10/31/2019 |
Pierwsze przesłane: | 06/23/2019 |
Szacowana liczba przesłanych rejestracji: | 06/23/2019 |
Wysłany pierwszy: | 06/25/2019 |
Ostatnia aktualizacja przesłana: | 11/11/2019 |
Ostatnia opublikowana aktualizacja: | 11/13/2019 |
Rzeczywista data rozpoczęcia badania: | 06/23/2019 |
Szacowana data zakończenia podstawowej działalności: | 05/31/2021 |
Szacowana data zakończenia badania: | 11/30/2021 |
Stan lub choroba
Interwencja / leczenie
Drug: Experimental Arm
Faza
Grupy ramion
Ramię | Interwencja / leczenie |
---|---|
Experimental: Experimental Arm All participants to receive study intervention. | Drug: Experimental Arm 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). |
Kryteria kwalifikacji
Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
Płeć kwalifikująca się do nauki | All |
Przyjmuje zdrowych wolontariuszy | tak |
Kryteria | Inclusion Criteria: - Age 18 years - Patients diagnosed with RP - Informed consent - Authorization of use and disclosure of protected health information Exclusion Criteria: - 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 - Patients with an active ocular infection - Patients with uncontrolled hypertension (defined as diastolic blood pressure > 95 mm Hg or systolic blood pressure > 160 mm Hg despite medical therapy) |
Wynik
Podstawowe miary wyników
1. Blood Pressure (mmHg) [Up to 2 years]
2. Tolerability of N-Acetylcysteine as assessed by drug-related symptoms [Up to 2 years]
3. Tolerability of N-Acetylcysteine as assessed by time at which medication is taken [Up to 2 years]
4. Tolerability of N-Acetylcysteine as assessed by number of times medication is taken per day [Up to 2 years]
Miary wyników wtórnych
1. Change in best corrected visual acuity (BCVA) [Baseline, every three months up to 2 years]
2. Change in central retinal sensitivity as assessed by microperimetry [Baseline, every three months up to 2 years]
3. Change in ellipsoid zone (EZ) width (µm) [Baseline, every three months up to 2 years]
4. Change in aqueous reduced to oxidized glutathione ratio (GSH/GSSG) [Baseline, every three months up to 2 years]
5. Change in serum carbonyl content (nmol/mg) [Baseline, every three months up to 2 years]
6. Change in aqueous levels of N-Acetylcysteine (mg) [Baseline, every 6 months up to 2 years]
7. Change in plasma levels of N-Acetylcysteine (µg/ml) [Baseline, every 3 months up to 2 years]