Diabetic Macular Edema (DME), Neovascular (Wet) Age-Related Macular Degeneration
Conditions
Keywords
nAMD, wAMD, DME, AMD, Ollin, OLN324
Brief summary
A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324
Detailed description
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)
Interventions
DRUGFaricimab
Intravitreal Injection
DRUGOLN324
Intravitreal Injection
Sponsors
Ollin Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | Week 12 and Week 20 |
Countries
Puerto Rico, United States
Outcome results
None listed