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

NCT07841899 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: OLN324-CP-02
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Diabetic Macular Edema (DME)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in BCVA

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

  Day 1 to Week 48

Secondary Outcomes (5)

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

  Day 1 to Week 20

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

  Day 1 to Week 20

• Time to DME resolution in the Study Eye

  Enrollment through study completion, an average of 2 years

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

  Day 1 to Week 48

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

  Week 48

Study Arms (2)

OLN324

EXPERIMENTAL

Drug: OLN324

Aflibercept

ACTIVE COMPARATOR

Drug: Aflibercept

Interventions

OLN324 DRUG

OLN324 by intravitreal injection at protocol-specified dosing intervals

OLN324

Aflibercept DRUG

Aflibercept by intravitreal injection at protocol specified dosing intervals

Aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ollin Biosciences, Inc.: lead

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Varun Malhotra, MD

CONTACT

737-330-1517; ollinclinops@ollin.bio

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share