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NCT07842016Not yet recruitingPhase 3

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

A Phase 3, Randomized, Double-masked, Multicenter, Active Comparator-controlled Trial to Investigate the Efficacy and Safety of Intravitreal OLN324 in Adult Participants With Diabetic Macular Edema (DME) (GOBI)

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
450 (estimated)
First submitted
7 Sept 2026
Start date
15 Oct 2026
Primary completion date
15 Dec 2028
Lead sponsor
Ollin Biosciences, Inc.
NCT number
NCT07842016

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 450
  • From 15 Oct 2026 to the primary completion date, 15 Dec 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • History of cataract surgery in the study eye within 90 days of Screening
  • Has uncontrolled hypertension
  • Has had a stroke or myocardial infarction within 180 days

Other

  • Be pregnant or breastfeeding
  • Has uncontrolled glaucoma in the study eye
  • Additional exclusion criteria apply

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.