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

Phase 3Not Yet RecruitingNCT07842016

Ollin Biosciences, Inc.450 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

450

Conditions

Diabetic Macular Edema (DME)

Interventions

OLN324DRUG

OLN324 by intravitreal injection at protocol-specified dosing intervals

AfliberceptDRUG

Aflibercept by intravitreal injection at protocol specified dosing intervals

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

Central Contacts

Varun Malhotra, MD

CONTACT

737-330-1517 ollinclinops@ollin.bio

Data from ClinicalTrials.gov

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