Diabetic Macular EdemaPhase 2NCT03466099
Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)
A Phase 2 study testing KVD001 Injection in people with Diabetic Macular Edema, run by KalVista Pharmaceuticals, Ltd. at 35 sites in United States.
Trial summary
This is a clinical study where patients with diabetes and a vision threatening eye condition called "Diabetic Macular Edema" receive four injections into the eye at monthly intervals. The patients will already have tried the standard of care without complete success. 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?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 35 sitesUnited States
- Study dates
- 16 Feb 2018to 10 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Type I or Type II diabetes mellitus (DM).
- BCVA of ≥19 letters (~20/400) and ≤73 letters (~20/40) in the study eye and ≥34 letters(~20/200 or better) in the fellow eye.
- Presence of ciDME in the study eye defined as CST ≥305 μm in women and ≥320 μm in men
- Subjects first anti-VEGF injection in the study eye occurred ≤36 months.
- Subjects have received at least 3 anti-vascular endothelial growth factor (VEGF) injections in the study eye within a 6-month period.
- The last anti-VEGF injection in the study eye is ≥ 8 weeks.
Who cannot join
- Evidence of ocular pathology (e.g. visually significant cataract) that impacts subject's vision in the study eye from any cause other than DME.
- Evidence/presence of amblyopia, vitreomacular traction, epiretinal membrane, foveal atrophy, or foveal ischemia, or any other condition in the macula that is thought to impair the subject's vision (other than DME).
- Prior treatment with panretinal photocoagulation or focal grid macular photocoagulation in the study eye within the previous 3 months.
- Prior treatment with intravitreal (IVT) steroid in the study eye (in the previous 3 months for triamcinolone, previous 6 months for Ozurdex and at any time for Iluvien).
- Prior treatment with topical NSAIDs or topical steroids in the study eye within 1 month.
- Prior treatment with systemic corticosteroids or systemic anti-VEGF therapy within 3 months.
Show all 14Show fewer
- Prior vitrectomy in the study eye.
- Prior intraocular surgery in the study eye except for cataract surgery. Cataract surgery within the previous 6 months in the study eye is excluded.
- Intraocular pressure (IOP) of >22 mmHg in the study eye or use of >2 antiglaucoma agents (combination agents count as 2 agents) in the study eye.
- Evidence of infectious dacrocystitis, significant blepharitis, active conjunctivitis, infectious keratitis, or scleritis in either eye, or any other condition that might affect the safety of the IVT injection.
- Current active proliferative diabetic retinopathy (PDR), active anterior segment neovascularization (ASNV), active retinal neovascularization, or the presence of vitreous hemorrhage in the study eye.
- Poorly controlled DM.
- Uncontrolled hypertension
- Prior treatment with ocriplasminin the study eye within 3 months
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
KalVista Investigative Site
Abilene, Texas, 79606
KalVista Investigative Site
Arcadia, California, 91007
KalVista Investigative Site
Arlington, Texas, 76012
KalVista Investigative Site
Augusta, Georgia, 30909
KalVIsta Investigative Site
Austin, Texas, 78705
KalVista Investigative Site
Beverly Hills, California, 90211
KalVista Investigative Site
Boston, Massachusetts, 02114
KalVista Investigative Site
Boston, Massachusetts, 02215
KalVista Investigative Site
Charlottesville, Virginia, 22903
KalVista Investigative Site
Cincinnati, Ohio, 45219
KalVista Investigative Site
Dallas, Texas, 75231
KalVista Investigative Site
Fort Myers, Florida, 33912
KalVista Investigative Site
Fort Worth, Texas, 76102
KalVista Investigative Site
Golden, Colorado, 80401
KalVista Investigative Site
Henderson, Nevada, 89052
KalVista Investigative Site
Indianapolis, Indiana, 46290
KalVista Investigative Site
Lynbrook, New York, 11563
KalVista Investigative Site
Marietta, Georgia, 30060
KalVista Investigative Site
Miami, Florida, 33126
KalVista Investigative Site
Miami, Florida, 33143
KalVista Investigative Site
Palm Desert, California, 92260
KalVista Investigative Site
Palo Alto, California, 94303
KalVista Investigative Site
Pensacola, Florida, 32503
KalVista Investigative Site
Phoenix, Arizona, 85021
KalVista Investigative Site
Phoenix, Arizona, 85053
KalVista Investigative Site
Rapid City, South Dakota, 57701
KalVista Investigative Site
Rochester, New York, 14459
KalVista Investigative Site
Sacramento, California, 95819
KalVista Investigative Site
San Antonio, Texas, 78240-1502
KalVista Investigative Site
San Antonio, Texas, 78240
KalVista Investigative Site
Santa Ana, California, 92705
KalVista Investigative Site
Silverdale, Washington, 98383
KalVista Investigative Site
Tucson, Arizona, 85704
KalVista Investigative Site
Tustin, California, 92780
KalVista Investigative Site
Winter Haven, Florida, 33880
About this study
Official title: A Randomized Sham-controlled Double-masked Phase 2a Study of the Efficacy, Safety and Tolerability of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema Who Have Had Prior Anti-vascular Endothelial Growth Factor Treatment
This is a clinical study where patients with diabetes and a vision threatening eye condition called "Diabetic Macular Edema" receive four injections into the eye at monthly intervals. The patients will already have tried the standard of care without complete success. The patients will be randomized to receive either a high dose, a low dose or a sham control treatment. The study will evaluate whether the new treatment improves vision and whether it changes the underlying course of the disease in the eye.
- Conditions
- Diabetic Macular Edema
- Being tested
- KVD001 Injection, Sham Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KVD001 InjectionDrug
Also called KVD001
Intravitreal KVD001 Injection
Sham ProcedureOther
Sham Procedure
| Study group | Role | What they receive |
|---|---|---|
| KVD001 Injection (high dose) | Experimental | Not described Receives: Drug: KVD001 Injection |
| KVD001 Injection (low dose) | Experimental | Not described Receives: Drug: KVD001 Injection |
| Sham Procedure | Sham comparator | Not described Receives: Other: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
Change from Baseline in Best Corrected Visual Acuity (BCVA)
Measured: 16 weeks
Secondary outcomes (2)
DRSS
Assessments of Diabetic Retinopathy Severity Score (DRSS, scale 10-85) to evaluate the percentage of eyes with a ≥2 step reduction in score from the baseline retinopathy severity as graded from fundus photography. Minimum and maximum values of the DRSS are 10 and 85, with the low end of the scale indicating absence of retinopathy which, as the score increases, so does the severity of the retinopathy such that a score of 85 is indicative of advanced proliferative diabetic retinopathy
Measured: 16 weeks
CST
Assessments of Central Subfold Thickness (CST) - analysis of covariance of change from baseline in the study eye at week 16
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start16 Feb 2018
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
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.
- 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, KalVista Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466099
- Sponsor's protocol ID
- KVD001-201
- Status last verified
- Jan 2021
- First submitted
- 26 Feb 2018
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Sham-controlled Double-masked Phase 2a Study of the Efficacy, Safety and Tolerability of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema Who Have Had Prior Anti-vascular Endothelial Growth Factor Treatment
- ClinicalTrials.gov ID
- NCT03466099
- Acronym / sponsor ID
- KVD001-201
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Posted 8 Dec 2020
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 clinical study where patients with diabetes and a vision threatening eye condition called "Diabetic Macular Edema" receive four injections into the eye at monthly intervals. The patients will already have tried the standard of care without complete success. The patients will be randomized to receive either a high dose, a low dose or a sham control treatment. The study will evaluate whether the new treatment improves vision and whether it changes the underlying course of the disease in the eye.
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 |
|---|---|---|
| KVD001 Injection (high dose) | Experimental | Drug: KVD001 Injection |
| KVD001 Injection (low dose) | Experimental | Drug: KVD001 Injection |
| Sham Procedure | Sham comparator | Other: Sham Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of Type I or Type II diabetes mellitus (DM).
- BCVA of ≥19 letters (~20/400) and ≤73 letters (~20/40) in the study eye and ≥34 letters(~20/200 or better) in the fellow eye.
- Presence of ciDME in the study eye defined as CST ≥305 μm in women and ≥320 μm in men
- Subjects first anti-VEGF injection in the study eye occurred ≤36 months.
- Subjects have received at least 3 anti-vascular endothelial growth factor (VEGF) injections in the study eye within a 6-month period.
Key exclusion criteria (14 listed)
- Evidence of ocular pathology (e.g. visually significant cataract) that impacts subject's vision in the study eye from any cause other than DME.
- Evidence/presence of amblyopia, vitreomacular traction, epiretinal membrane, foveal atrophy, or foveal ischemia, or any other condition in the macula that is thought to impair the subject's vision (other than DME).
- Prior treatment with panretinal photocoagulation or focal grid macular photocoagulation in the study eye within the previous 3 months.
- Prior treatment with intravitreal (IVT) steroid in the study eye (in the previous 3 months for triamcinolone, previous 6 months for Ozurdex and at any time for Iluvien).
- Prior treatment with topical NSAIDs or topical steroids in the study eye within 1 month.
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: KVD001Intravitreal KVD001 Injection | Drug | KVD001 Injection (high dose), KVD001 Injection (low dose) |
| Sham ProcedureSham Procedure | Other | Sham Procedure |
Primary outcome
BCVA
Time frame: 16 weeks
Change from Baseline in Best Corrected Visual Acuity (BCVA)
2 secondary outcomes
DRSS
Time frame: 16 weeks
CST
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Study Director study director
KalVista Pharmaceuticals
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KVD001 Injection in people with Diabetic Macular Edema, run by KalVista Pharmaceuticals, Ltd. at 35 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 6 inclusion and 14 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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. 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 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 8 Dec 2020). 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?
BCVA (time frame: 16 weeks). 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 28 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.