OLX10212 for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Olix Pharmaceuticals, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for men and women over 50 with neovascular age-related macular degeneration (AMD). Participants must have certain vision scores, a primary lesion caused by AMD, and be able to attend all visits. They can't join if they've had recent anti-VEGF therapy in either eye or other treatments that could affect the study.

Inclusion Criteria

I am 50 years old or older.

CNV must be ≥50% of the total lesion size in the study eye

ETDRS BCVA score ranging from 20/60 to 20/400 in the study eye

+5 more

Exclusion Criteria

I haven't had an eye infection in the last 2 weeks.

More than half of the lesion in my eye is scarred or has fibrosis.

I haven't received anti-VEGF therapy in my eye within the last 4 weeks.

+26 more

Participant Groups

OLX10212, a new type of RNA-based treatment, is being tested in two parts: one where patients get a single dose and another with multiple doses. The goal is to see how safe it is and how well it works when injected into the eye of those with neovascular AMD.

7Treatment groups

Experimental Treatment

Group I: Part B 950 μg/eye/50 μLExperimental Treatment1 Intervention

study eye treated with a total of 3 intravitreal injections of 950 μg (895.9 μg free acid) of OLX10212 each 28 days apart

Group II: Part B 750 μg/eye/50 μLExperimental Treatment1 Intervention

study eye treated with a total of 3 intravitreal injections of 750 μg (707.3 μg free acid) of OLX10212 each 28 days apart

Group III: Part A 950 μg/eye/50 μLExperimental Treatment1 Intervention

study eye treated with 950 μg (895.9 μg free acid) of OLX10212

Group IV: Part A 750 μg/eye/50 μLExperimental Treatment1 Intervention

study eye treated with 750 μg (707.3 μg free acid) of OLX10212

Group V: Part A 500 μg/eye/50 μLExperimental Treatment1 Intervention

study eye treated with 500 μg (471.5 μg free acid) of OLX10212