| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03927690 | Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema | PHASE2 | COMPLETED | 91 | — | — | May 24, 2019 | Aug 31, 2022 | Jun 20, 2024 | 22 | United States, Germany +3 |
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.
| Arm | Type | Description |
|---|---|---|
| LKA651 | EXPERIMENTAL | LKA651 Intravitreal injection |
| LKA651 + Lucentis | EXPERIMENTAL | LKA651 + Lucentis Intravitreal injection |
| Lucentis | ACTIVE_COMPARATOR | Lucentis Intravitreal injection |
| 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 |
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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