A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324

Ollin Biosciences, Inc.164 enrolled

Overview

A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Two Different Formulations of Intravitreal OLN324 in Adult Participants With Either Neovascular (Wet) Age-related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

164

Conditions

Diabetic Macular Edema (DME)Neovascular (Wet) Age-Related Macular Degeneration

Interventions

FaricimabDRUG

Intravitreal Injection

OLN324DRUG

Intravitreal Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity * DME patients must be ≥ 18 years of age, nAMD patients must be ≥ 50 years of age * Diagnosis of either DME or nAMD. nAMD patients must be treatment naïve. DME patients can be either treatment naïve or treatment experienced * DME patients must have best corrected visual acuity of 78 to 25 letters * nAMD patients must have best corrected visual acuity of 80 to 25 letters Exclusion Criteria: * If pregnant or breastfeeding * History of cataract surgery and/or Yttrium-Aluminum Garnet (YAG) for removal of posterior capsular opacification (PCO) within 90 days

Locations (30)

Phoenix, AZ

Outcomes

Primary Outcomes

Adverse Events

Time frame: Week 12 and Week 20

Data from ClinicalTrials.gov

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