drugset / Trial / NCT02341560
Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will determine the effect of QPI-1007 on visual function in subjects with recent-onset NAION and assess the safety and tolerability of intravitreal injections of QPI-1007 in this population. This study will also evaluate the structural changes in the retina following administration of QPI-1007.
Timeline
- Start
- 2016-02-24
- Primary completion
- 2019-07-01
- Completion
- 2019-07-01
Publications
- Woods B, Szanto D, Wang JK, Erekat A, Golden A, Garvin MK, Williams ZR, Linton EF, Kardon RH, Kupersmith MJ. Early Optic Nerve Head Swelling Rate Is Associated with Worsening of Visual Outcomes in Nonarteritic Anterior Ischemic Optic Neuropathy. Ophthalmology. 2026 May 18:S0161-6420(26)00360-X. doi: 10.1016/j.ophtha.2026.05.013. Online ahead of print.
- Davis JL. The Blunt End: Surgical Challenges of Gene Therapy for Inherited Retinal Diseases. Am J Ophthalmol. 2018 Dec;196:xxv-xxix. doi: 10.1016/j.ajo.2018.08.038. Epub 2018 Sep 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | QPI-1007 | Small interfering RNA (siRNA) | 1.5 mg | Intravitreal |
| Comparator | QPI-1007 | Small interfering RNA (siRNA) | 3 mg | Intravitreal |