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

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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07816289

Acronym

SAHARA

Enrollment

400

Registered

2026-09-11

Start date

2026-10-15

Completion date

2029-12-15

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Age-related Macular Degeneration

Keywords

Ollin, Ollin Biosciences, Inc., nAMD, wet AMD, Neovascular AMD, Age-related macular degeneration, Wet age-related macular degeneration, Neovascular age-related macular degeneration, OLN324, wAMD

Brief 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).

Interventions

DRUGOLN324

OLN324 by intravitreal injection monthly

DRUGRanibizumab

Ranibizumab by intravitreal injection monthly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in BCVA	Day 1 to Week 36	Changes in BCVA ETDRS letter score from Day 1 to Week 36

Secondary

Measure	Time frame	Description
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

Contacts

CONTACTVarun Malhotra, MD

ollinclinops@ollin.bio737-330-1517

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026