Phase 3 Study of Intravitreal OLN324 in Adults With Neovascular (Wet) Age-related Macular Degeneration (nAMD) (OLN324-CP-05)

NCT07816289 — Phase 3, Not yet recruiting, 400 participants, Ollin Biosciences, Inc.

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A Phase 3, Randomized, Double-masked, Multicenter, Active Comparator-controlled Trial to Investigate the Efficacy and Safety of Monthly Intravitreal OLN324 in Adult Participants With Neovascular (Wet) Age-related Macular Degeneration (nAMD)

Registry	NCT07816289, acronym SAHARA
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	400 (Estimated)
Sponsor	Ollin Biosciences, Inc. (Industry)
Conditions	Wet Age-related Macular Degeneration
Interventions	OLN324, Ranibizumab (Drug)
Dates	start 2026-10-15 (estimated), primary completion 2028-12-15 (estimated), completion 2029-12-15 (estimated), first posted 2026-09-11, last updated 2026-09-11

-Summary

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).

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+Arms and interventions

Arm	Type	Interventions	Description
OLN324	Experimental	Drug: OLN324
Ranibizumab	Active comparator	Drug: Ranibizumab

OLN324 (Drug): OLN324 by intravitreal injection monthly
Ranibizumab (Drug): Ranibizumab by intravitreal injection monthly

+Outcome measures

Primary outcomes

Change in BCVA [Day 1 to Week 36]: Changes in BCVA ETDRS letter score from Day 1 to Week 36

Secondary outcomes

Mean change in OCT CST [Day 1 to Week 12]: 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 [Day 1 to Week 12]: 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 [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

+Eligibility

Sex: All, ages: 50 Years to any

Inclusion Criteria:

* 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
* Additional inclusion criteria apply

Exclusion Criteria:

* 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
* Has had a stroke or myocardial infarction within 180 days
* Additional exclusion criteria apply