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

Ollin Biosciences, Inc.

Status and phase

Not yet enrolling

Phase 3

Conditions

Diabetic Macular Edema (DME)

Treatments

Drug: OLN324

Drug: Aflibercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT07842016

OLN324-CP-03

Details and patient eligibility

About

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).

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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