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LKA651 for Diabetic Macular Edema

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (0, 0.5 and 4 hrs post dose), day 2, day 8, day 15, day 29 (0, 0.5 and 4 hrs post dose), day 43, day 57 (0, 0.5 and 4 hrs post dose), day 85
Awards & highlights

Study Summary

This study is evaluating whether a drug may help treat diabetic macular edema.

Eligible Conditions
  • Diabetic Macular Edema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (0, 0.5 and 4 hrs post dose), day 2, day 8, day 15, day 29 (0, 0.5 and 4 hrs post dose), day 43, day 57 (0, 0.5 and 4 hrs post dose), day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (0, 0.5 and 4 hrs post dose), day 2, day 8, day 15, day 29 (0, 0.5 and 4 hrs post dose), day 43, day 57 (0, 0.5 and 4 hrs post dose), day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Charts in Study Eye
Inner Macular Thickness (Inferior)
Inner Macular Thickness (Temporal)
+8 more
Secondary outcome measures
Number of Participants Who Needed Retreatment With Anti-VEGF in Study Eye After Week 12
Summary Statistics of Pharmacokinetics - AUC0-28d of LKA651 (Serum)
Summary Statistics of Pharmacokinetics - AUC0-28d of Lucentis (Serum)
+3 more

Side effects data

From 2022 Phase 2 trial • 91 Patients • NCT03927690
11%
Diabetic retinal oedema
11%
Visual acuity reduced
11%
Hypertension
7%
Hyperglycaemia
7%
Macular oedema
7%
Ocular hypertension
7%
COVID-19
7%
Blood creatinine increased
4%
SARS-CoV-2 test positive
4%
XIIth nerve injury
4%
Blood triglycerides increased
4%
Acute kidney injury
4%
Nephrolithiasis
4%
Atrial fibrillation
4%
Myopathy
4%
Herpes zoster
4%
Blood urea increased
4%
Urine leukocyte esterase positive
4%
Vitreous haemorrhage
4%
Conjunctivitis
4%
Urinary tract infection
4%
Cystoid macular oedema
4%
Corneal erosion
4%
Sinus bradycardia
4%
Dacryostenosis acquired
4%
Diabetic retinopathy
4%
Haemorrhagic stroke
4%
Retinal cyst
4%
Hepatic steatosis
4%
Conjunctival haemorrhage
4%
Lipase increased
4%
Hyponatraemia
4%
COVID-19 pneumonia
4%
Anaemia
4%
Eye pain
4%
Hyperlipasaemia
4%
Retinal detachment
4%
Retinal haemorrhage
4%
Retinal exudates
4%
Chronic kidney disease
4%
Hypertriglyceridaemia
4%
Acute respiratory failure
4%
Blood creatine phosphokinase increased
4%
Pancreatic enzymes increased
4%
Urine ketone body present
4%
Blood glucose increased
4%
Intraocular pressure increased
4%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
LKA651
LKA651 + Lucentis
Lucentis
Total

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: LKA651 + LucentisExperimental Treatment2 Interventions
LKA651 + Lucentis Intravitreal injection
Group II: LKA651Experimental Treatment1 Intervention
LKA651 Intravitreal injection
Group III: LucentisActive Control1 Intervention
Lucentis Intravitreal injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LKA651
2019
Completed Phase 2
~120
Lucentis
2008
Completed Phase 4
~7020

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,614 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema
2019. "Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03927690.
~16 spots leftby Apr 2025
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