NCT07816289

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
39mo left

Started Oct 2026

Typical duration for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2029

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

2.2 years

First QC Date

September 7, 2026

Last Update Submit

September 7, 2026

Conditions

Wet Age-related Macular Degeneration

Keywords

OllinOllin Biosciences, Inc.nAMDwet AMDNeovascular AMDAge-related macular degenerationWet age-related macular degenerationNeovascular age-related macular degenerationOLN324wAMD

Outcome Measures

Primary Outcomes (1)

  • Change in BCVA

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

    Day 1 to Week 36

Secondary Outcomes (3)

  • Mean change in OCT CST

    Day 1 to Week 12

  • Change in PED thickness

    Day 1 to Week 12

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

    Week 12

Study Arms (2)

OLN324

EXPERIMENTAL
Drug: OLN324

Ranibizumab

ACTIVE COMPARATOR
Drug: Ranibizumab

Interventions

OLN324DRUG

OLN324 by intravitreal injection monthly

OLN324
RanibizumabDRUG

Ranibizumab by intravitreal injection monthly

Ranibizumab

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Varun Malhotra, MD

CONTACT

737-330-1517ollinclinops@ollin.bio

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 11, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

December 15, 2028

Study Completion (Estimated)

December 15, 2029

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share