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Not yet recruitingNCT07842016GOBIUpdated Sep 25, 2026

Phase 3 Study of Intravitreal OLN324 in Adults With Diabetic Macular Edema (DME) (OLN324-CP-03)

A Phase 3 interventional study of OLN324 and Aflibercept in Diabetic Macular Edema (DME), sponsored by Ollin Biosciences, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Ollin Biosciences, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 diabetic macular edema (DME).

02

Conditions studied

  • Diabetic Macular Edema (DME)

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Keywords

  • DME
  • Diabetic Macular Edema
  • Diabetic Retinopathy
  • Diabetic Eye Disease
  • OLN324
  • Ollin
  • Ollin Biosciences, Inc.
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Capable of giving signed informed consent
  • Be ≥18 years of age.
  • Have type 1 or type 2 diabetes mellitus
  • Have a decrease in vision in the study eye due to diabetic macular edema (DME), with best corrected visual acuity of 78 to 25 letters
  • Have macular edema on OCT with a CST of ≥ 325 µm
  • Participants may be either treatment-naïve or previously-treated for DME in their study eye. The number of previously-treated participants is limited.
  • Additional inclusion criteria apply

Exclusion criteria

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
  • If in the cohort of previously treated for DME participants, prior treatment with intravitreal bevacizumab, aflibercept, faricimab, ranibizumab, conbercept, or other approved anti-VEGF or Anti-VEGF/Anti-Ang-2 therapies within 90 days of randomization.
  • Additional exclusion criteria apply
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
450 participants (estimated)

Study arms

  • Experimental
    OLN324

    Drug: OLN324

  • Active comparator
    Aflibercept

    Drug: Aflibercept

Interventions

  • DrugOLN324

    OLN324 by intravitreal injection at protocol-specified dosing intervals

  • DrugAflibercept

    Aflibercept by intravitreal injection at protocol specified dosing intervals

05

What researchers measure

Primary outcomes

  1. Change in BCVA

    Change in ETDRS BCVA eye chart letter score from Day 1 to Week 48.

    Time frame: Day 1 to Week 48

Secondary outcomes

  1. Mean change in OCT CST in the Study Eye from baseline at Week 20

    Difference in the mean change from baseline in OCT CST in the Study Eye between the OLN324 arm and the aflibercept arm

    Time frame: Day 1 to Week 20

  2. Percentage of participants with absence of DME in the Study Eye at Week 20

    Difference in the percentage of participants with absence of DME in the Study Eye between the OLN324 arm and the aflibercept arm

    Time frame: Day 1 to Week 20

  3. Time to DME resolution in the Study Eye

    Difference in the time to first DME resolution in the Study Eye

    Time frame: Enrollment through study completion, an average of 2 years

  4. Mean change in OCT CST in the Study Eye from baseline at Week 48

    Difference in the mean change from baseline in OCT CST in the Study Eye between the OLN324 arm and the aflibercept arm

    Time frame: Day 1 to Week 48

  5. Percentage of participants with absence of DME in the Study Eye at Week 48

    Difference in the percentage of participants with absence of DME in the Study Eye between the OLN324 arm and the aflibercept arm

    Time frame: Week 48

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07842016
Lead sponsor
Ollin Biosciences, Inc.
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Dec 15, 2028 (estimated)
Completion
Dec 15, 2029 (estimated)
Last update
Sep 25, 2026

Study contacts

Varun Malhotra, MD
Contact
ollinclinops@ollin.bio
737-330-1517

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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