NCT07847723Toborzás még nem indult1. fázis
Phase I/II Open-Label Trial of UGX202 for Advanced Retinitis Pigmentosa
An Open-label, Dose-escalation and Expanded Phase I/II Clinical Trial to Evaluate the Safety and Preliminary Efficacy of UGX202 Injection in Patients With Advanced Retinitis Pigmentosa
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 2.
Rövid összefoglaló (regiszter, angolul)
This is a single-arm, open-label study employing a 3+3 dose escalation design to evaluate two UGX202 dose groups: the low-dose group (1.2×10¹¹ vg/eye) and the high-dose group (3.5×10¹¹ vg/eye). According to the "Dose Escalation Rule" (see below), each dose group comprised 3-6 study participants; thus, a total of 6-12 study participants were enrolled in this phase. Participants were enrolled in ascending order from the lowest to the highest dose; each study participant could participate in only one dose group (defined as having received the investigational drug - participants who had not received the drug were not considered to have participated in any dose group), and could not participate in multiple dose groups sequentially.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 12 (tervezett)
- Első benyújtás
- 2026. szept. 17.
- Kezdés
- 2026. szept. 28.
- Elsődleges befejezés
- 2029. febr. 15.
- Fő szponzor
- Suzhou UgeneX Therapeutics Co., Ltd.
- Betegségek
- Retinitis pigmentosa
- NCT-szám
- NCT07847723
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 12
- 2026. szept. 28. és az elsődleges befejezés (2029. febr. 15.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- The study eye has previously received any form of gene therapy.
- The participant has participated in another interventional clinical trial within 90 days before screening.
- The study eye has undergone vitrectomy or macular surgery.
- The study eye has undergone major surgery or intraocular surgery within the 3 months before screening, as determined by the investigator.
Más betegség
- The participant has a disease of the study eye or a systemic disease that, in the investigator's opinion, may affect visual function assessment, such as macular degeneration, retinal detachment, retinal arteriolar or venous occlusion, glaucoma, or a central nervous system disorder affecting visual function.
- The participant has an ocular disease or abnormality that may affect safety assessment, such as an active ocular infection, chronic uveitis, or ocular trauma within the preceding 3 months.
Egyéb
- The study eye has an abnormality that may interfere with visual acuity or other ophthalmic assessments, such as opacity of the ocular media that affects fundus examination. At the investigator's discretion, participants with cataracts that do not significantly impair visual acuity may be enrolled.
- The participant has a contraindication to pupil dilation, such as a narrow anterior chamber angle.
Kiket keres a vizsgálat
- The participant voluntarily signs the informed consent form (ICF).
- The participant is older than 18 years at the time of signing the ICF.
- The participant has a confirmed diagnosis of non-syndromic retinitis pigmentosa (RP)
- Best-corrected visual acuity (BCVA) in the study eye is <0.05, or the ETDRS letter score is ≤19 letters.
- The participant's pupil can be sufficiently dilated to allow comprehensive ophthalmic examination and testing.
- The participant agrees to use effective contraception from enrollment until at least 1 year after the last administration of study treatment. Effective methods include complete abstinence (if this is the participant's preferred and usual lifestyle), an intrauterine device, bilateral tubal ligation, a partner who has undergone vasectomy with confirmed azoospermia, or a dual-barrier method (a male condom used with a cervical cap, diaphragm, or spermicidal sponge).
- The spherical equivalent refractive error of the study eye is between -6.00 D and +6.00 D, inclusive.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.