Yükleniyor... / Loading...
Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients
Bu açık etiketli doz artırım çalışması, QPI-1007 adlı siRNA (küçük engelleyici RNA) ilacının göz içine (intravitreal) enjekte edildiğinde güvenli olup olmadığını araştırmıştır. Çalışmada ayrıca yan etkiler ve ilacın vücuttan ne kadar sürede temizlendiği incelenmiştir. Faz 1 (Phase 1) çalışmaya kronik optik sinir atrofisi olan ve yeni başlangıçlı NAION (non-arteritik ön iskemik optik nöropati) tanısı alan hastalar dahil edilmiştir.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Key Stratum I (Chronic Optic Nerve Atrophy) Inclusion Criteria: * "Legally blind" in the study eye as the result of an irreversible condition affecting the posterior segment of the eye. * Clear ocular media and able to undergo adequate pupil dilation. * Visual acuity and visual field in the non-study eye are better than or equal to the study eye * At least 21 years old. Key Stratum I (Chronic Optic Nerve Atrophy) Exclusion Criteria: * For the study eye only: history of any IVT injection or vitrectomy, vitreous hemorrhage, retinal detachment, or active inflammatory condition (e.g. conjunctivitis). * For either eye: history of uveitis. Enrollment is now closed in Stratum I. Key Stratum II (Acute NAION) Inclusion Criteria: * Positive diagnosis of NAION with symptom onset within 28 days prior to planned dosing with QPI-1007. * Visual acuity in the study eye is between 20/40 and light perception. * Clear ocular media and able to undergo adequate pupil dilation. * At least 50 years old. Key Stratum II (Acute NAION) Exclusion Criteria: * For the study eye only: Macular disease, retinopathy, or other eye disease limiting visual acuity; prior intraocular surgery (other than Lasik) and cataract surgery within 3 months prior to dosing; glaucoma laser surgery within 1 month prior to dosing; pain on or aggravated by eye movement; history of vitreous hemorrhage; history of retinal detachment; any active inflammatory condition (e.g. conjunctivitis); glaucoma or ocular hypertension; or intraocular pressure \> 26 mmHg. * For either eye: History of optic neuritis; or history of uveitis. * Received any treatment for NAION prior to dosing. * Any other abnormality which in the opinion of the investigator is suggestive of a disease other than NAION in the study eye only. * Clinical evidence of temporal arteritis. * History of collagen vascular disease or other inflammatory disease, or history of multiple sclerosis. Enrollment in Stratum II is still open.