Health TrialsbyHealthPanel

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

ConditionDiabetic Macular Edema (DME)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOllin Biosciences, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • OLN324

    Drug

    OLN324 by intravitreal injection at protocol-specified dosing intervals

  • Aflibercept

    Drug

    Aflibercept by intravitreal injection at protocol specified dosing intervals

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: OLN324Experimental treatment 1 intervention
Group B: AfliberceptActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ollin Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: