Diabetic Macular EdemaPhase 1NCT02193113
A Phase I Single Ascending Dose Study of the Intravitreal Plasma Kallikrein Inhibitor KVD001 in Subjects With DME
A Phase 1 study testing KVD001 Injection in people with Diabetic Macular Edema, run by KalVista Pharmaceuticals, Ltd. at 5 sites in United States.
Trial summary
This is a Phase 1 study to investigate the safety, tolerability of the novel plasma kallikrein inhibitor, KVD001 in subjects with diabetic macular edema. The study is the first step to investigate the hypothesis that plasma kallikrein plays an important role in the disease process behind diabetic macular edema in many… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- KVD001 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Jul 2014to 4 Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult subjects 18 years of age and older
- Confirmed diagnosis of Type I or Type II diabetes mellitus
- Best corrected visual acuity, using Early Treatment Diabetic Retinopathy Study (ETDRS) electronic visual acuity (EVA) testing, of between 20/40 and 20/400 (Snellen equivalent) in the study eye
- Fellow eye acuity 20/80 or better measured as above with no expectation of requirement for anti-VEGF treatment in fellow eye within 2 months of study drug administration
- Presence of central involved DME in the study eye defined as Optical Coherence Tomography (OCT) Central Subfold Thickness (CST) ≥305 µm in women and ≥320 µm in men in the study eye
- Subjects who fulfil one of the following criteria:
Show all 15Show fewer
- Subjects who have not previously received an anti-VEGF treatment and who, in the view of the Investigator, can have initiation of anti-VEGF treatment in the study eye deferred for at least 2 months following the date of anticipated study drug administration
- Subjects who are receiving regular anti-VEGF intravitreal injections who:
- Have received at least 3 intravitreal injections of an anti-VEGF treatment within the last 5 months (study drug administration will be at least 6 weeks after the most recent intravitreal administration of anti-VEGF) and
- In the view of the Investigator, can have continuation of anti-VEGF treatment in the study eye deferred for at least 2 months following the date of anticipated study drug administration
- Subjects who have received anti-VEGF in the past (>3 months prior to study inclusion) but are not actively receiving treatment and who in the view of the Investigator, can have resumption of anti-VEGF or alternative treatment in the study eye deferred for at least 2 months following anticipated study drug administration
- Subjects, who in the view of the Investigator, are not expected to require panretinal laser photocoagulation or intravitreal steroids or intraocular surgery in the study eye for at least 2 months following anticipated study drug administration
- No prior treatment with panretinal photocoagulation or intravitreal steroid in the study eye within the previous 3 months
- No prior treatment with systemic corticosteroids or systemic anti-VEGF therapy within the previous 3 months
- Study participant voluntarily agrees to participate in this study and signs the Institutional Review Board (IRB) approved informed consent prior to performing any procedure
Who cannot join
- Females who are pregnant or lactating, or expecting to become pregnant during the course of the study
- Poorly controlled diabetes mellitus
- Uncontrolled hypertension
- Significant co-existing disease
- Participation in an investigational intervention clinical study within 2 months prior to study inclusion
- History of alcohol and/or drug abuse in the last 2 years
Show all 9Show fewer
- Men not willing to use appropriate birth control methods
- Media clarity or pupillary dilation inadequate to obtain reasonable quality OCT and/or fundus image
- Subjects employed by the Sponsor or in any relationship of dependence with the Sponsor and/or Investigator
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Beetham Eye Institute
Boston, Massachusetts, 02215
Raj K. Maturi, MD PC
Indianapolis, Indiana, 46290
Valley Retina Institute, PA
McAllen, Texas, 78503
Palmetto Retina Center
West Columbia, South Carolina, 29169
About this study
Official title: An Open Label, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacodynamics of a Novel Intravitreal Plasma Kallikrein Inhibitor in Subjects With Central Involved Diabetic Macular Edema and Reduced Vision
This is a Phase 1 study to investigate the safety, tolerability of the novel plasma kallikrein inhibitor, KVD001 in subjects with diabetic macular edema. The study is the first step to investigate the hypothesis that plasma kallikrein plays an important role in the disease process behind diabetic macular edema in many patients
Read the detailed description
The plasma kallikrein-kinin system has long been recognized as a key player in inflammatory processes, capillary leakage and angiogenesis in various organs. Recent work suggests that plasma kallikrein is central to the pathogenesis of Diabetic Macular Edema (DME) and that activation of the enzyme contributes to the excessive retinal vascular permeability leading to DME. Among different persons with DME, plasma kallikrein contributes both independently in some, and in association with Vascular Endothelial Growth Factor (VEGF) in others. However, the effect of plasma kallikrein appears to be independent of VEGF. Thus, growing scientific evidence points to plasma kallikrein inhibitors as an exciting potential new therapeutic opportunity directed at a novel VEGF-independent pathway that may reduce retinal vascular permeability and treat DME, in patients whose disease process is, at least in part, driven by the plasma kallikrein pathway.
This is an open label, single ascending dose study to investigate the safety, tolerability and pharmacodynamics of a novel plasma kallikrein inhibitor administered by intravitreal (IVT) injection in subjects with central involved diabetic macular edema and reduced vision.
- Conditions
- Diabetic Macular Edema
- Being tested
- KVD001 Injection
- Keywords
- Diabetic Macular Edema, DME, Plasma Kallikrein inhibitor, KVD001, KVD001-001, Intravitreal, IVT, Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KVD001 InjectionDrug
Also called KVD001
A novel plasma kallikrein inhibitor
| Study group | Role | What they receive |
|---|---|---|
| KVD001 Injection Dose 1 | Experimental | Single 100 microliters (uL) intravitreal injection of KVD001 Injection Dose 1 Receives: Drug: KVD001 Injection |
| KVD001 Injection Dose 2 | Experimental | Single 100uL intravitreal injection KVD001 injection Dose 2 Receives: Drug: KVD001 Injection |
| KVD001 Injection Dose 3 | Experimental | Single 100uL intravitreal injection of KVD001 injection Dose 3 Receives: Drug: KVD001 Injection |
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
Measured: 56 days
Secondary outcomes (2)
Measurement of KVD001 plasma levels over time following intravitreal injection (with calculation of Tmax, Cmax, AUC and t1/2)
Measured: 28 days
Best Corrected Visual Acuity as measured by ETDRS EVA
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study start18 Jul 2014
- Primary completion4 Jun 2015
- Study completion4 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Jennifer Sun, MD, MPH, Principal investigator, Joslin Diabetes CenterDavid Boyer, MD, Principal investigator, Retina-Vitreous Associates Medical GroupVictor Gonzalez, MD, Principal investigator, Valley Retina Institute, PARaj Maturi, MD, Principal investigator, Midwest Eye InstituteJack Wells, MD, Principal investigator, Palmetto Retina Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193113
- Sponsor's protocol ID
- KVD001-001
- Status last verified
- Mar 2017
- First submitted
- 9 Jul 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacodynamics of a Novel Intravitreal Plasma Kallikrein Inhibitor in Subjects With Central Involved Diabetic Macular Edema and Reduced Vision
- ClinicalTrials.gov ID
- NCT02193113
- Acronym / sponsor ID
- KVD001-001
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, DME, Plasma Kallikrein inhibitor, KVD001, KVD001-001, Intravitreal, IVT, Diabetes mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 18 Jul 2014 (actual)
- Primary completion
- 4 Jun 2015 (actual)
- Study completion
- 4 Jun 2015 (actual)
- First posted
- 17 Jul 2014 (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.
This is a Phase 1 study to investigate the safety, tolerability of the novel plasma kallikrein inhibitor, KVD001 in subjects with diabetic macular edema. The study is the first step to investigate the hypothesis that plasma kallikrein plays an important role in the disease process behind diabetic macular edema in many patients
Detailed description
The plasma kallikrein-kinin system has long been recognized as a key player in inflammatory processes, capillary leakage and angiogenesis in various organs. Recent work suggests that plasma kallikrein is central to the pathogenesis of Diabetic Macular Edema (DME) and that activation of the enzyme contributes to the excessive retinal vascular permeability leading to DME. Among different persons with DME, plasma kallikrein contributes both independently in some, and in association with Vascular Endothelial Growth Factor (VEGF) in others. However, the effect of plasma kallikrein appears to be independent of VEGF. Thus, growing scientific evidence points to plasma kallikrein inhibitors as an exciting potential new therapeutic opportunity directed at a novel VEGF-independent pathway that may reduce retinal vascular permeability and treat DME, in patients whose disease process is, at least in part, driven by the plasma kallikrein pathway.
This is an open label, single ascending dose study to investigate the safety, tolerability and pharmacodynamics of a novel plasma kallikrein inhibitor administered by intravitreal (IVT) injection in subjects with central involved diabetic macular edema and reduced vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KVD001 Injection Dose 1 | Experimental | Drug: KVD001 InjectionSingle 100 microliters (uL) intravitreal injection of KVD001 Injection Dose 1 |
| KVD001 Injection Dose 2 | Experimental | Drug: KVD001 InjectionSingle 100uL intravitreal injection KVD001 injection Dose 2 |
| KVD001 Injection Dose 3 | Experimental | Drug: KVD001 InjectionSingle 100uL intravitreal injection of KVD001 injection Dose 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female adult subjects 18 years of age and older
- Confirmed diagnosis of Type I or Type II diabetes mellitus
- Best corrected visual acuity, using Early Treatment Diabetic Retinopathy Study (ETDRS) electronic visual acuity (EVA) testing, of between 20/40 and 20/400 (Snellen equivalent) in the study eye
- Fellow eye acuity 20/80 or better measured as above with no expectation of requirement for anti-VEGF treatment in fellow eye within 2 months of study drug administration
- Presence of central involved DME in the study eye defined as Optical Coherence Tomography (OCT) Central Subfold Thickness (CST) ≥305 µm in women and ≥320 µm in men in the study eye
Key exclusion criteria (9 listed)
- Females who are pregnant or lactating, or expecting to become pregnant during the course of the study
- Poorly controlled diabetes mellitus
- Uncontrolled hypertension
- Significant co-existing disease
- Participation in an investigational intervention clinical study within 2 months prior to study inclusion
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 |
|---|---|---|
| KVD001 InjectionAlso: KVD001A novel plasma kallikrein inhibitor | Drug | KVD001 Injection Dose 1, KVD001 Injection Dose 2, KVD001 Injection Dose 3 |
Primary outcome
Number of participants with Adverse Events as a measure of safety and tolerability
Time frame: 56 days
2 secondary outcomes
Measurement of KVD001 plasma levels over time following intravitreal injection (with calculation of Tmax, Cmax, AUC and t1/2)
Time frame: 28 days
Best Corrected Visual Acuity as measured by ETDRS EVA
Time frame: 56 days
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 3 Mar 2017.
- Sponsor's Website (KalVista Pharmaceuticals)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
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.
Jennifer Sun, MD, MPH principal investigator
Joslin Diabetes Center
David Boyer, MD principal investigator
Retina-Vitreous Associates Medical Group
Victor Gonzalez, MD principal investigator
Valley Retina Institute, PA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KVD001 Injection in people with Diabetic Macular Edema, run by KalVista Pharmaceuticals, Ltd. at 5 sites in United States.
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 15 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 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: 56 days). 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 3 Mar 2017.