Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LKA651 · 2 trials · 4 indications
An AE is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation patient. The severity of the AEs (mild, moderate, severe) was based on the Common Terminology Criteria for Adverse Events (CTCAE). Number of participants in each category is reported in the table. A participant who falls multiple times in one category is counted only once.
An AE is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation patient.
An AE is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation patient.
Intraocular pressure was measured per the study site's regular practice.
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. BCVA in study eye was analyzed with a mixed model for repeated measures. The model included treatment, visit, and the treatment by visit interaction as independent variables. An unstructured residual covariance structure was used. Baseline BCVA value and treatment naïve and treatment experienced variable were used as covariates. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Foveal avascular zone was assessed by fluorescein angiography (FA).
Central subfield thickness was measured by spectral domain optical coherence tomography (SD-OCT). Central subfield retinal thickness was analyzed with a mixed model for repeated measures. The model included treatment, visit, and the treatment by visit interaction as independent variables. An unstructured residual covariance structure was used. Log-transformed baseline central subfield retinal thickness and treatment naïve and treatment experienced variable were used as covariates. Results were back-transformed to show results as a ratio to baseline.
To evaluate the safety and tolerability of LKA651 by reviewing any adverse events after medical or ophthalmic examinations that are possibly or probably related to study drug.
| Arm | Type | Description |
|---|---|---|
| LKA651 | EXPERIMENTAL | LKA651 Intravitreal injection |
| LKA651 + Lucentis | EXPERIMENTAL | LKA651 + Lucentis Intravitreal injection |
| Lucentis | ACTIVE_COMPARATOR | Lucentis Intravitreal injection |
| Sham Comparator | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| LKA651 | DRUG | LKA651 5 mg Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase |
| Lucentis | DRUG | 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 |
| Sham Comparator | OTHER | - |
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 t...
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LKA651 is an investigational small molecule being developed by Novartis for the treatment of diabetic macular edema and macular edema. It is administered via intravitreal injection and has been studied in patients with these retinal conditions, as well as in those with neovascular age-related macular degeneration and retinal vein occlusions.
LKA651 is a small molecule designed for intravitreal administration in the eye. Its specific molecular target has not been disclosed. Clinical studies have assessed its safety, tolerability, pharmacokinetics, and pharmacodynamic activity in patients with macular edema, including diabetic macular edema.
LKA651 is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis has sponsored clinical trials of LKA651 in patients with diabetic macular edema and other forms of macular edema.
LKA651 has completed a Phase 2 clinical trial in patients with diabetic macular edema. The drug remains investigational and has not been approved by regulatory authorities. Earlier, a Phase 1 study also evaluated its safety and tolerability in patients with macular edema.
LKA651 has been studied in two completed clinical trials. NCT02867735 was a Phase 1 study of safety, tolerability, pharmacokinetics, and pharmacodynamic activity in patients with macular edema. NCT03927690 was a Phase 2 multiple-dose study of safety and efficacy in patients with diabetic macular edema.
LKA651 is a distinct investigational small molecule developed by Novartis. It is not known to be the same as any other marketed drug. Its mechanism of action has not been publicly disclosed, and it is being studied specifically for intravitreal use in retinal conditions.