Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-03 @ 11:55 PM
Study NCT ID:
NCT05643118
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2022-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of OLX10212 in Patients With Neovascular Age-related Macular Degeneration
Sponsor:
Olix Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
Evaluation of the Safety and Tolerability of OLX10212 in Patients With Neovascular Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
This is a Phase 1, multicenter, open-label, single- and multi-dose, dose escalation study to evaluate the safety, tolerability, and preliminary efficacy of OLX10212 in the treatment of 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, i.e. participants will receive one intravitreal injection of OLX10212 at different dose levels and Part B is a multiple ascending dose study, i.e. participants will receive up to three intravitreal injections of OLX10212. Up to 42 individuals with AMD will be invited to participate in this study. The mechanism of action of OLX10212 holds promise to treat AMD by improving inflammation in the retina which is typically observed in patients with AMD. This is the first time OLX10212 is used in patients with AMD. Safety and tolerability of OLX10212 will be assessed via detailed ophthalmologic evaluations, vital signs, and clinical laboratory testing. In addition, plasma concentrations of OLX10212 will be measured and evaluations of the therapeutic effects of OLX10212 will be performed.
Part A uses a dose-ascending, sequential design to evaluate up to five doses of OLX10212, starting with the lowest dose of OLX10212 in a 50-μL injection. Up to six patients will be enrolled at each dose level. Each of the enrolled patients will receive a single intravitreal administration of OLX10212. The safety and tolerability evaluation period will encompass the first 14 days following OLX10212 administration. The effects of OLX10212 will be observed up to 24-weeks after injection. Based on the safety and tolerability evaluation, a decision will be made whether or not to increase the dose to the next higher dose levels for the subsequent patient cohorts. Therefore, a total of up to 30 patients (up to 5 dose levels and up to 6 patients/dose level) will be enrolled in Part A of this study.
Part B of this study uses a dose-ascending, sequential design to evaluate 2 dose levels of OLX10212 (750 and 950 μg/eye/50 μL), starting with the 750 μg/eye/50 μL dose. Three patients will initially be enrolled in each cohort. Each of the enrolled patients will receive a total of up to three intravitreal injections of OLX10212, each four weeks apart (Week 0, Week 4, and Week 8). The DLT evaluation period will encompass the first 10 weeks following the first OLX10212 administration (ending 2 weeks following the third OLX10212 administration), during which safety and tolerability will be assessed at each visit. In addition, the plasma concentrations of OLX10212 will be measured and therapeutic effects will be evaluated. A total of up to 12 patients with AMD (3 dose levels and up to 6 patients/dose level) will be invited to participate in Part B of this study.
Part A uses a dose-ascending, sequential design to evaluate up to five doses of OLX10212, starting with the lowest dose of OLX10212 in a 50-μL injection. Up to six patients will be enrolled at each dose level. Each of the enrolled patients will receive a single intravitreal administration of OLX10212. The safety and tolerability evaluation period will encompass the first 14 days following OLX10212 administration. The effects of OLX10212 will be observed up to 24-weeks after injection. Based on the safety and tolerability evaluation, a decision will be made whether or not to increase the dose to the next higher dose levels for the subsequent patient cohorts. Therefore, a total of up to 30 patients (up to 5 dose levels and up to 6 patients/dose level) will be enrolled in Part A of this study.
Part B of this study uses a dose-ascending, sequential design to evaluate 2 dose levels of OLX10212 (750 and 950 μg/eye/50 μL), starting with the 750 μg/eye/50 μL dose. Three patients will initially be enrolled in each cohort. Each of the enrolled patients will receive a total of up to three intravitreal injections of OLX10212, each four weeks apart (Week 0, Week 4, and Week 8). The DLT evaluation period will encompass the first 10 weeks following the first OLX10212 administration (ending 2 weeks following the third OLX10212 administration), during which safety and tolerability will be assessed at each visit. In addition, the plasma concentrations of OLX10212 will be measured and therapeutic effects will be evaluated. A total of up to 12 patients with AMD (3 dose levels and up to 6 patients/dose level) will be invited to participate in Part B of this study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: