About this trial
This is a Phase 3 study of an investigational drug called OLN324, which is being developed by Ollin Biosciences as a treatment for patients with neovascular (wet) age-related macular degeneration (nAMD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Capable of giving signed informed consent
Be ≥50 years of age
Treatment-naive nAMD in the study eye with active subfoveal choroidal neovascularization (CNV)
Have a decrease in vision in the study eye due to nAMD, with best corrected visual acuity of 78 to 24 letters
Disqualifiers
Be pregnant or breastfeeding
History of cataract surgery in the study eye within 90 days of Screening
Has uncontrolled glaucoma in the study eye
Has uncontrolled hypertension
Trial design
Parallel
Treatments tested in this trial
OLN324
DrugOLN324 by intravitreal injection monthly
Ranibizumab
DrugRanibizumab by intravitreal injection monthly
Treatment groups
Trial outcomes
Primary outcomes
Change in BCVA
Changes in BCVA ETDRS letter score from Day 1 to Week 36
Secondary outcomes
Mean change in OCT CST
Difference in the mean change from baseline in OCT CST in the Study Eye between the OLN324 arm and the ranibizumab arm
Change in PED thickness
Difference in the mean change from baseline in PED thickness on OCT in the Study Eye between the OLN324 arm and the ranibizumab arm
Percentage of participants without retinal fluid in the central subfield at Week 12
Difference in the percentage of participants with absence of both IRF and SRF in the central subfield of the Study Eye between the OLN324 arm and the ranibizumab arm
Locations
Sponsors and contacts
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