Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)

January 5, 2021 updated by: KalVista Pharmaceuticals, Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85021
        • KalVista Investigative Site
      • Phoenix, Arizona, United States, 85053
        • KalVista Investigative Site
      • Tucson, Arizona, United States, 85704
        • KalVista Investigative Site
    • California
      • Arcadia, California, United States, 91007
        • KalVista Investigative Site
      • Beverly Hills, California, United States, 90211
        • KalVista Investigative Site
      • Palm Desert, California, United States, 92260
        • KalVista Investigative Site
      • Palo Alto, California, United States, 94303
        • KalVista Investigative Site
      • Sacramento, California, United States, 95819
        • KalVista Investigative Site
      • Santa Ana, California, United States, 92705
        • KalVista Investigative Site
      • Tustin, California, United States, 92780
        • KalVista Investigative Site
    • Colorado
      • Golden, Colorado, United States, 80401
        • KalVista Investigative Site
    • Florida
      • Fort Myers, Florida, United States, 33912
        • KalVista Investigative Site
      • Miami, Florida, United States, 33126
        • KalVista Investigative Site
      • Miami, Florida, United States, 33143
        • KalVista Investigative Site
      • Pensacola, Florida, United States, 32503
        • KalVista Investigative Site
      • Winter Haven, Florida, United States, 33880
        • KalVista Investigative Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • KalVista Investigative Site
      • Marietta, Georgia, United States, 30060
        • KalVista Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • KalVista Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • KalVista Investigative Site
      • Boston, Massachusetts, United States, 02215
        • KalVista Investigative Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • KalVista Investigative Site
    • New York
      • Lynbrook, New York, United States, 11563
        • KalVista Investigative Site
      • Rochester, New York, United States, 14459
        • KalVista Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • KalVista Investigative Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • KalVista Investigative Site
    • Texas
      • Abilene, Texas, United States, 79606
        • KalVista Investigative Site
      • Arlington, Texas, United States, 76012
        • KalVista Investigative Site
      • Austin, Texas, United States, 78705
        • KalVista Investigative Site
      • Dallas, Texas, United States, 75231
        • KalVista Investigative Site
      • Fort Worth, Texas, United States, 76102
        • KalVista Investigative Site
      • San Antonio, Texas, United States, 78240-1502
        • KalVista Investigative Site
      • San Antonio, Texas, United States, 78240
        • KalVista Investigative Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • KalVista Investigative Site
    • Washington
      • Silverdale, Washington, United States, 98383
        • KalVista Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham Procedure
Other: Sham Procedure
Sham Procedure
Experimental: KVD001 Injection (high dose)
Drug: KVD001 Injection
Intravitreal KVD001 Injection
Other Names:
  • KVD001
Experimental: KVD001 Injection (low dose)
Drug: KVD001 Injection
Intravitreal KVD001 Injection
Other Names:
  • KVD001

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
BCVA
Time Frame: 16 weeks
Change from Baseline in Best Corrected Visual Acuity (BCVA)
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DRSS
Time Frame: 16 weeks
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
16 weeks
CST
Time Frame: 16 weeks
Assessments of Central Subfold Thickness (CST) - analysis of covariance of change from baseline in the study eye at week 16
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KalVista Pharmaceuticals, Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, KalVista Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KVD001-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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