Phase 1CompletedAge-related condition
Evaluation of OLX10212 in Patients With Neovascular Age-related Macular Degeneration
Evaluation of the Safety and Tolerability of OLX10212 in Patients With Neovascular Age-Related Macular Degeneration
- Sponsor
- Olix Pharmaceuticals, Inc. (Industry)
- Enrollment
- 21 enrolled
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)
- Ages
- adults, older adults
- Registry
- NCT05643118
Full record on ClinicalTrials.gov
From the registry
This is a Phase 1, multicenter, open-label, single- and multi-dose, dose-escalating study of OLX10212 in patients with neovascular age-related macular degeneration (AMD). This study is composed of 2 parts: Part A and Part B. Part A is a single ascending dose study, and Part B is a multiple ascending dose study. The primary objective is to evaluate the safety and tolerability of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD. The exploratory objectives are to evaluate the preliminary efficacy of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD, and to evaluate the pharmacokinetics (PK) of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD.
Primary outcomes
- Best-corrected visual acuity (BCVA)
- Intraocular pressure (IOP)
- Slit lamp
- Fundus examination
History
Last registry update
Study completion
Primary completion
Started
Registered