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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

Summary

This trial tests a new drug, LKA651, alone and with an existing treatment, Lucentis, for patients with diabetic macular edema (DME). DME causes swelling in the eye due to diabetes. LKA651's effectiveness and safety are being evaluated, while Lucentis is known to reduce swelling by stopping harmful blood vessel growth.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Summary Statistics of Pharmacokinetics - AUC0-28d of LKA651 (Serum)
Summary Statistics of Pharmacokinetics - AUC0-28d of Lucentis (Serum)
Summary Statistics of Pharmacokinetics - Serum Concentrations of LKA651
+1 more

Side effects data

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

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
2,889 Previous Clinical Trials
4,201,913 Total Patients Enrolled
~15 spots leftby Sep 2025
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