Diabetic Macular EdemaPhase 2NCT03927690
Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema
A Phase 2 study testing LKA651 and Lucentis in people with Diabetic Macular Edema, run by Novartis Pharmaceuticals at 22 sites in 5 countries.
Trial 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), Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- LKA651 and Lucentis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 24 May 2019to 31 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
United States7 sites
Novartis Investigative Site
‘Aiea, Hawaii, 96701
Novartis Investigative Site
Austin, Texas, 78750
Novartis Investigative Site
Beverly Hills, California, 90211
Novartis Investigative Site
Boston, Massachusetts, 02118
Novartis Investigative Site
Miami, Florida, 33143
Novartis Investigative Site
Rancho Cordova, California, 95670
Novartis Investigative Site
San Antonio, Texas, 78240
Germany5 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Münster, 48145
Novartis Investigative Site
Tübingen, 72076
Spain5 sites
Novartis Investigative Site
Barcelona, 08025
Novartis Investigative Site
Córdoba, 14012
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, 08190
Novartis Investigative Site
Seville, Andalusia, 41009
Novartis Investigative Site
Zaragoza, 50009
Turkey (Türkiye)4 sites
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Ankara, 06490
Novartis Investigative Site
Ankara, 06500
Novartis Investigative Site
Kocaeli, 41380
About this study
Official title: A Randomized, Active-controlled, Patient and Investigator-masked, Multiple Dose Proof-of-concept Study of Intravitreal LKA651 in Patients With Diabetic Macular Edema
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),
Read the detailed description
This study was a 3-arm, parallel group, randomized, patient- and investigator-masked trial planned in 90 patients with Diabetic macular edema (DME). The study consisted of a screening period of 60 days, main study (12 weeks), and an extension period (12 weeks). The study was stratified such that sentinel safety cohorts were first enrolled to test the safety of the combination of LKA651 and Lucentis before proceeding with further patient randomization. After determination of safety from Day 15 data from each sentinel cohort, patients were enrolled into 1 of 3 arms: LKA651 monotherapy, LKA651 plus Lucentis, and Lucentis monotherapy. Every patient was dosed 3 times in 4 week intervals in the treatment phase and was then followed up for an extension phase of an additional 12 weeks during which Lucentis was allowed to be administered as rescue at the discretion of the Investigator. No predefined rescue criteria were outlined as guidance.
- Conditions
- Diabetic Macular Edema
- Being tested
- LKA651, Lucentis
- Keywords
- Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, AMD, diabetic macular edema, DME, neovascular age-related macular degeneration, nAMD, retinal vein occlusion, RVO, Diabetic Macular edema (DME), macular edema, diabetic retinopathy, LKA651, Lucentis
- Medical subject headings
- Macular Degeneration, Vision Disorders, Geographic Atrophy, Wet Macular Degeneration, Retinal Vein Occlusion, Macular Edema, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LKA651Drug
LKA651 5 mg Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase
LucentisDrug
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
| Study group | Role | What they receive |
|---|---|---|
| LKA651 | Experimental | LKA651 Intravitreal injection Receives: Drug: LKA651 |
| LKA651 + Lucentis | Experimental | LKA651 + Lucentis Intravitreal injection Receives: Drug: LKA651; Drug: Lucentis |
| Lucentis | Active comparator | Lucentis Intravitreal injection Receives: Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
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.
Measured: Adverse events are reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum timeframe of approximately 24 weeks (approximately 168 days).
Number of Participants With Ocular Adverse Events by Preferred Term in Study Eye
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.
Measured: Adverse events are reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum timeframe of approximately 24 weeks (approximately 168 days).
Number of Participants With Non-ocular Adverse Events (>=2%)
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.
Measured: Adverse events are reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum timeframe of approximately 24 weeks (approximately 168 days).
Intraocular Pressure (IOP) in Study Eye
Intraocular pressure was measured per the study site's regular practice.
Measured: Screening, and Day 85
Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Charts in Study Eye
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.
Measured: Days 2, 8, 15, 29, 43, 57, and 85
Inner Macular Thickness (Inferior)
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Measured: Week 12 (Day 85)
Inner Macular Thickness (Temporal)
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Measured: Week 12 (Day 85)
Outer Macular Thickness (Inferior)
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Measured: Week 12 (Day 85)
Outer Macular Thickness (Temporal)
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Measured: Week 12 (Day 85)
Number of Participants Without Changes in Foveal Avascular Zone as Measured by Fluorescein Angiography (FA) in Study Eye
Foveal avascular zone was assessed by fluorescein angiography (FA).
Measured: Days 29, 57, 85, End of Study (Up to Day 140)
Mixed Model Repeated Measures Analysis of Ratio to Baseline in Central Subfield Retinal Thickness (CSFT) in the Study Eye
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.
Measured: Days 8, 15, 29, 43, 57, 85
Secondary outcomes (6)
Number of Participants Who Needed Retreatment With Anti-VEGF in Study Eye After Week 12
Measured: Week 12 (Day 85) up to Day 140
Time to Retreatment in Study Eye With Anti-VEGF After Week 12
Time to retreatment with anti VEGF (as determined by the investigator) after Week 12 during the additional 12 week extension phase (that was up to 16 weeks after the last dose) was examined with a Kaplan Meier plot.
Measured: Week 12 (Day 85) up to Day 140
Summary Statistics of Pharmacokinetics - Serum Concentrations of LKA651
PK parameters were determined using non-compartmental methods using the most recent version of WinNonlin Phoenix (Version 8.2).
Concentrations below the lower limit of quantification (LLOQ) were treated as 1/2 LLOQ in summary statistics.
Measured: 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
Summary Statistics of Pharmacokinetics - AUC0-28d of LKA651 (Serum)
Area under the curve over the dosing interval 0 to 28 days.
Measured: Day 1 - 4 hrs post dose, Day 2, Day 8, Day 15, Day 29 - 4 hrs post dose, Day 43, Day 57 - 4 hrs post dose, Day 85
Summary Statistics of Pharmacokinetics - Serum Concentrations of Lucentis
Measured: Day 1 - 4 hrs post dose, Day 2, Day 8, Day 15, Day 29 - 4 hrs post dose, Day 43, Day 57 - 4 hrs post dose, Day 85
Summary Statistics of Pharmacokinetics - AUC0-28d of Lucentis (Serum)
Area under the curve over the dosing interval 0 to 28 days.
Measured: Day 1 - 4 hrs post dose, Day 2, Day 8, Day 15, Day 29 - 4 hrs post dose, Day 43, Day 57 - 4 hrs post dose, Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start24 May 2019
- Primary completion17 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927690
- Sponsor's protocol ID
- CLKA651X2202
- Other IDs
- 2018-000031-28, 2018
- Status last verified
- Jun 2024
- First submitted
- 23 Apr 2019
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active-controlled, Patient and Investigator-masked, Multiple Dose Proof-of-concept Study of Intravitreal LKA651 in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03927690
- Acronym / sponsor ID
- CLKA651X2202
- Conditions
- Diabetic Macular Edema
- Keywords
- Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 May 2019 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Posted 12 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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),
Detailed description
This study was a 3-arm, parallel group, randomized, patient- and investigator-masked trial planned in 90 patients with Diabetic macular edema (DME). The study consisted of a screening period of 60 days, main study (12 weeks), and an extension period (12 weeks). The study was stratified such that sentinel safety cohorts were first enrolled to test the safety of the combination of LKA651 and Lucentis before proceeding with further patient randomization. After determination of safety from Day 15 data from each sentinel cohort, patients were enrolled into 1 of 3 arms: LKA651 monotherapy, LKA651 plus Lucentis, and Lucentis monotherapy. Every patient was dosed 3 times in 4 week intervals in the treatment phase and was then followed up for an extension phase of an additional 12 weeks during which Lucentis was allowed to be administered as rescue at the discretion of the Investigator. No predefined rescue criteria were outlined as guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LKA651 | Experimental | Drug: LKA651LKA651 Intravitreal injection |
| LKA651 + Lucentis | Experimental | Drug: LKA651, Drug: LucentisLKA651 + Lucentis Intravitreal injection |
| Lucentis | Active comparator | Drug: LucentisLucentis Intravitreal injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LKA651LKA651 5 mg Intravitreal injection, every 4 weeks for 12 weeks in the treatment phase | Drug | LKA651, LKA651 + Lucentis |
| LucentisLucentis 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 | Drug | LKA651 + Lucentis, Lucentis |
Primary outcome
Number of Participants With Adverse Events
Time frame: Adverse events are reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum timeframe of approximately 24 weeks (approximately 168 days).
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.
Number of Participants With Ocular Adverse Events by Preferred Term in Study Eye
Time frame: Adverse events are reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum timeframe of approximately 24 weeks (approximately 168 days).
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.
Number of Participants With Non-ocular Adverse Events (>=2%)
Time frame: Adverse events are reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum timeframe of approximately 24 weeks (approximately 168 days).
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 (IOP) in Study Eye
Time frame: Screening, and Day 85
Intraocular pressure was measured per the study site's regular practice.
Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Charts in Study Eye
Time frame: Days 2, 8, 15, 29, 43, 57, and 85
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.
Inner Macular Thickness (Inferior)
Time frame: Week 12 (Day 85)
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Inner Macular Thickness (Temporal)
Time frame: Week 12 (Day 85)
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Outer Macular Thickness (Inferior)
Time frame: Week 12 (Day 85)
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Outer Macular Thickness (Temporal)
Time frame: Week 12 (Day 85)
Macular thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Number of Participants Without Changes in Foveal Avascular Zone as Measured by Fluorescein Angiography (FA) in Study Eye
Time frame: Days 29, 57, 85, End of Study (Up to Day 140)
Foveal avascular zone was assessed by fluorescein angiography (FA).
Mixed Model Repeated Measures Analysis of Ratio to Baseline in Central Subfield Retinal Thickness (CSFT) in the Study Eye
Time frame: Days 8, 15, 29, 43, 57, 85
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.
6 secondary outcomes
Number of Participants Who Needed Retreatment With Anti-VEGF in Study Eye After Week 12
Time frame: Week 12 (Day 85) up to Day 140
Time to Retreatment in Study Eye With Anti-VEGF After Week 12
Time frame: Week 12 (Day 85) up to Day 140
Summary Statistics of Pharmacokinetics - Serum Concentrations of LKA651
Time frame: 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
Summary Statistics of Pharmacokinetics - AUC0-28d of LKA651 (Serum)
Time frame: Day 1 - 4 hrs post dose, Day 2, Day 8, Day 15, Day 29 - 4 hrs post dose, Day 43, Day 57 - 4 hrs post dose, Day 85
Summary Statistics of Pharmacokinetics - Serum Concentrations of Lucentis
Time frame: Day 1 - 4 hrs post dose, Day 2, Day 8, Day 15, Day 29 - 4 hrs post dose, Day 43, Day 57 - 4 hrs post dose, Day 85
Summary Statistics of Pharmacokinetics - AUC0-28d of Lucentis (Serum)
Time frame: Day 1 - 4 hrs post dose, Day 2, Day 8, Day 15, Day 29 - 4 hrs post dose, Day 43, Day 57 - 4 hrs post dose, Day 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Patient Lay Trial SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LKA651 and Lucentis in people with Diabetic Macular Edema, run by Novartis Pharmaceuticals at 22 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Germany, Spain, Turkey (Türkiye), Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: Adverse events are reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to a maximum timeframe of approximately 24 weeks (approximately 168 days).). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.