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NCT Number: NCT07816289

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

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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Key information

Conditions

Wet Age-related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OLN324

Drug

OLN324 by intravitreal injection monthly

ranibizumab

Drug

Ranibizumab by intravitreal injection monthly

Primary outcomes

  1. Change in BCVA

    Time frame: Day 1 to Week 36

    Changes in BCVA ETDRS letter score from Day 1 to Week 36

Secondary outcomes

  1. Mean change in OCT CST

    Time frame: 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

  2. Change in PED thickness

    Time frame: 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

  3. Percentage of participants without retinal fluid in the central subfield at Week 12

    Time frame: 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Ollin Biosciences, Inc.

Industry

Registry information

Official study title

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)

Acronym: SAHARA

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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