Phase 2
N=91
Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT03927690 ↗Enrolled (actual)
91
Serious AEs
8.8%
Results posted
Oct 2023
Primary outcome: Primary: Number of Participants With Adverse Events — 20; 16; 19; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LKA651 (Drug); Lucentis (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
20; 16; 19; 16; 15; 19 | — |
| PRIMARY Number of Participants With Ocular Adverse Events by Preferred Term in Study Eye |
11; 7; 9; 1; 4; 2 | — |
| PRIMARY Number of Participants With Non-ocular Adverse Events (>=2%) |
16; 15; 14 | — |
| PRIMARY Intraocular Pressure (IOP) in Study Eye |
15.1; 14.9; 15.5; 15.5; 15.6; 15.2 | — |
| PRIMARY Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Charts in Study Eye |
61.5; 64.4; 64.1; 65.2; 68.6; 66.2 | 0.887 |
| PRIMARY Inner Macular Thickness (Inferior) |
503.06; 400.82; 390.48 | — |
| PRIMARY Inner Macular Thickness (Temporal) |
505.27; 414.64; 404.93 | — |
| PRIMARY Outer Macular Thickness (Inferior) |
388.66; 349.39; 342.88 | — |
| PRIMARY Outer Macular Thickness (Temporal) |
404.60; 371.83; 352.24 | — |
| PRIMARY Number of Participants Without Changes in Foveal Avascular Zone as Measured by Fluorescein Angiography (FA) in Study Eye |
3; 16; 11; 3; 16; 7 | — |
| PRIMARY Mixed Model Repeated Measures Analysis of Ratio to Baseline in Central Subfield Retinal Thickness (CSFT) in the Study Eye |
0.99; 0.83; 0.83; 0.97; 0.83; 0.80 | 0.998 |
| SECONDARY Number of Participants Who Needed Retreatment With Anti-VEGF in Study Eye After Week 12 |
16; 16; 21 | — |
| SECONDARY Time to Retreatment in Study Eye With Anti-VEGF After Week 12 |
55.0; 34.0; 31.0 | — |
| SECONDARY Summary Statistics of Pharmacokinetics - Serum Concentrations of LKA651 |
0.00; 0.00; 0.00; 0.00; 114; 4.43 | — |
| SECONDARY Summary Statistics of Pharmacokinetics - AUC0-28d of LKA651 (Serum) |
— | — |
| SECONDARY Summary Statistics of Pharmacokinetics - Serum Concentrations of Lucentis |
— | — |
| SECONDARY Summary Statistics of Pharmacokinetics - AUC0-28d of Lucentis (Serum) |
— | — |
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),
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed.
- Male and female patients age 18 to 85 years of age inclusive at screening
- Presence of type I or type II diabetes mellitus
- The Early Treatment Diabetic Retinopathy Study (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
- Presence of Diabetic macular edema (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 Spectral domain optical coherence tomography (SD-OCT) and confirmed by the central reading center at screening
- Sufficiently clear ocular media and adequate pupil dilation in the study eye to permit fundus photographs of adequate clarity to measure diameters of retinal arteries and veins at screening
Exclusion criteria
- Patient with history of intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment in the study eye <90 days from baseline
- Patient with history of intraocular corticosteroids including dexamethasone intravitreal implants during the 6 month period prior to baseline. Any prior use of fluocinolone acetonide intravitreal implant (Iluvien) is prohibited regardless of timing
- Laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline.
- High risk proliferative diabetic retinopathy
- Patients, with type 1 or type 2 diabetes who have a hemoglobin A1C ≥ 12% at screening.
- Any progressive disease of the retina in the study eye (e.g. uveitis,rod-cone dystrophy) or optic nerve
- Area of macular retinal ischemia (as measured by the foveal avascular zone) ≥ 1000 μm.
- Active intraocular inflammation (graded as trace or above) or active intraocular infection in either eye.
- Current diagnosis of or laboratory evidence for anemia, defined as a hemoglobin <10 g/dL for women and <11 g/dL for men.
Data sourced from ClinicalTrials.gov (NCT03927690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.