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Not yet recruitingNCT07841899ATACAMAUpdated Sep 25, 2026

Phase 3 Study of Intravitreal OLN324 in Adults With Diabetic Macular Edema (DME) (OLN324-CP-02)

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

Updated Sep 25, 2026Newly registeredGo to Updates ↓
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
  • Ollin
  • OLN324
  • Diabetic Retinopathy
  • Diabetic Eye Disease
  • Ollin Biosciences, Inc.
03

In context

Diabetic Retinopathy

778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.

This study's planned enrollment of 450 is above the median of 80 across 481 interventional studies indexed under Diabetic Retinopathy.

Browse Diabetic Retinopathy studies →

Lead sponsor

Ollin Biosciences, Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Browse Ollin Biosciences, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Capable of giving signed
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.

Of 21 phase 3 interventional studies under Diabetic Retinopathy, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 41. This study's planned 26 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2026
First posted
Sep 25, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
Dec 15, 2028
CompletionEst.
Dec 15, 2029
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07841899
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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