Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema

• Status: Recruiting
• Trial end date: 2022-10-11
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME),

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ranibizumab

Criteria

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.

2. Male and female patients age 18 to 85 years of age inclusive at screening

3. Presence of type I or type II diabetes mellitus

4. The ETDRS letter score in the study eye must be between 24 and 70 letters (approximate Snellen equivalent of 20/40-20/320). The non-study eye (fellow eye) should be ≥34 letters or better (approximate Snellen equivalent of 20/200) at screening

5. Presence of DME in the study eye, with decrease in vision due to foveal thickening of central macular thickness ≥ 320 µm in the central subfield, as assessed on SD-OCT and confirmed by the central reading center at screening

Other protocol specified inclusion/exclusion criteria apply.