At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 91 enrolled
Drug / intervention
LKA651 +1 moredrug
Likely dose
LKA651 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Active-controlled, Patient and Investigator-masked, Multiple Dose Proof-of-concept Study of Intravitreal LKA651 in Patients With Diabetic Macular Edema
In Brief
A Phase 2 clinical trial evaluating LKA651 and Lucentis for Diabetic Macular Edema. Completed, enrolled 91 participants across 22 sites in 5 countries.
Detailed 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),
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesGermany, Puerto Rico, Spain, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartMay 2019
Primary CompletionJun 2022
Study CompletionAug 2022
TodayJul 2026
First PostedApr 25, 2019
Enrollment StartMay 24, 2019
Primary CompletionJun 17, 2022
Study CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.2 years ago
Interventions
LKA651drug
LKA651 5 mg Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase
Lucentisdrug
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