Macular EdemaPhase 1NCT02867735
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
A Phase 1 study testing LKA651 in people with Macular Edema and Diabetic Macular Edema, run by Novartis Pharmaceuticals at 6 sites in 2 countries.
Trial summary
To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Macular Edema, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
- What is being tested?
- LKA651
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 21 Sep 2016to 15 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- -Patients with macular edema with center involvement in at least one eye, including those with focal or diffuse DME, neovascular AMD, or RVO
- The ETDRS letter score in the study eye must be 60 letters or worse (approximate Snellen equivalent of 20/63)
- Vital signs as specified within the protocol
Who cannot join
- -Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage
- Patient, with type 1 or type 2 diabetes who have a hemoglobin A1C > or = 12% at screening
- other ocular conditions as specified in the protocol
- systemic conditions as specified in the protocol
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Novartis Investigative Site
Augusta, Georgia, 30909
Novartis Investigative Site
Fort Myers, Florida, 33901
Novartis Investigative Site
Miami, Florida, 33143
Novartis Investigative Site
Pasadena, California, 91105-3153
Novartis Investigative Site
Winter Haven, Florida, 33880
About this study
Official title: A Randomized, Single-masked, Sham-control, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema From Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (AMD), or Retinal Vein Occlusions (RVO)
To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO)
- Conditions
- Macular Edema, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Retinal Vein Occlusions
- Being tested
- LKA651, Sham Comparator
- Keywords
- Macular Edema, Diabetic Macular Edema (DME), Neovascular age-related Macular Degeneration(AMD), Retinal Vein Occlusions (RVO)
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LKA651Drug
Interventional
Sham ComparatorOther
| Study group | Role | What they receive |
|---|---|---|
| LKA651 | Experimental | Not described Receives: Drug: LKA651 |
| Sham Comparator | Sham comparator | Not described Receives: Other: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of participants with Adverse Events as a measure of Safety and Tolerability
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.
Measured: Day 1 through study completion
Secondary outcomes (2)
Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC)
To evaluate the serum pharmacokinetic profile of LKA651 Measured by AUC(0-last) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-time point.
Measured: Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85
Pharmacokinetics of Single Dose of LKA651 - Cmax
To evaluate the serum pharmacokinetic profile of LKA651 Measured by Cmax - The maximum plasma concentration of study medication.
Measured: Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start21 Sep 2016
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 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
- NCT02867735
- Sponsor's protocol ID
- CLKA651X2104
- Status last verified
- Apr 2022
- First submitted
- 9 Aug 2016
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-masked, Sham-control, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema From Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (AMD), or Retinal Vein Occlusions (RVO)
- ClinicalTrials.gov ID
- NCT02867735
- Acronym / sponsor ID
- CLKA651X2104
- Conditions
- Macular Edema, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Retinal Vein Occlusions
- Keywords
- Macular Edema, Diabetic Macular Edema (DME), Neovascular age-related Macular Degeneration(AMD), Retinal Vein Occlusions (RVO)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LKA651 | Experimental | Drug: LKA651 |
| Sham Comparator | Sham comparator | Other: Sham Comparator |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- -Patients with macular edema with center involvement in at least one eye, including those with focal or diffuse DME, neovascular AMD, or RVO
- The ETDRS letter score in the study eye must be 60 letters or worse (approximate Snellen equivalent of 20/63)
- Vital signs as specified within the protocol
Key exclusion criteria (4 listed)
- -Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage
- Patient, with type 1 or type 2 diabetes who have a hemoglobin A1C > or = 12% at screening
- other ocular conditions as specified in the protocol
- systemic conditions as specified in the protocol
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 |
|---|---|---|
| LKA651Interventional | Drug | LKA651 |
| Sham Comparator | Other | Sham Comparator |
Primary outcome
Number Of participants with Adverse Events as a measure of Safety and Tolerability
Time frame: Day 1 through study completion
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.
2 secondary outcomes
Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC)
Time frame: Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85
Pharmacokinetics of Single Dose of LKA651 - Cmax
Time frame: Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: Undecided. 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
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LKA651 in people with Macular Edema and Diabetic Macular Edema, run by Novartis Pharmaceuticals at 6 sites in 2 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 3 inclusion and 4 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 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 as a measure of Safety and Tolerability (time frame: Day 1 through study completion). 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 15 Apr 2022.