NCT03927690

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

A Randomized, Active-controlled, Patient and Investigator-masked, Multiple Dose Proof-of-concept Study of Intravitreal LKA651 in Patients With Diabetic Macular Edema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study were to evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME),

Detailed description

This study was a 3-arm, parallel group, randomized, patient- and investigator-masked trial planned in 90 patients with Diabetic macular edema (DME). The study consisted of a screening period of 60 days, main study (12 weeks), and an extension period (12 weeks). The study was stratified such that sentinel safety cohorts were first enrolled to test the safety of the combination of LKA651 and Lucentis before proceeding with further patient randomization. After determination of safety from Day 15 data from each sentinel cohort, patients were enrolled into 1 of 3 arms: LKA651 monotherapy, LKA651 plus Lucentis, and Lucentis monotherapy. Every patient was dosed 3 times in 4 week intervals in the treatment phase and was then followed up for an extension phase of an additional 12 weeks during which Lucentis was allowed to be administered as rescue at the discretion of the Investigator. No predefined rescue criteria were outlined as guidance.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	LKA651	LKA651 5 mg Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase
DRUG	Lucentis	Lucentis 0.3 mg (U.S. sites) or 0.5 mg (ex U.S. sites) Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase

Timeline

• Start date: 2019-05-24
• Primary completion: 2022-06-17
• Completion: 2022-08-31
• First posted: 2019-04-25
• Last updated: 2024-06-20
• Results posted: 2023-10-12

Locations

22 sites across 5 countries: United States, Germany, Puerto Rico, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study