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Trial record 1 of 2 for:    KVD001
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Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03466099
Recruitment Status : Completed
First Posted : March 15, 2018
Results First Posted : December 8, 2020
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
KalVista Pharmaceuticals, Ltd.

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: KVD001 Injection Other: Sham Procedure Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 16, 2018
Actual Primary Completion Date : October 10, 2019
Actual Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: KVD001 Injection (high dose) Drug: KVD001 Injection
Intravitreal KVD001 Injection
Other Name: KVD001
Experimental: KVD001 Injection (low dose) Drug: KVD001 Injection
Intravitreal KVD001 Injection
Other Name: KVD001
Sham Comparator: Sham Procedure Other: Sham Procedure
Sham Procedure


Outcome Measures
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Primary Outcome Measures :
  1. BCVA [ Time Frame: 16 weeks ]
    Change from Baseline in Best Corrected Visual Acuity (BCVA)


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466099


Locations
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United States, Arizona
KalVista Investigative Site
Phoenix, Arizona, United States, 85021
KalVista Investigative Site
Phoenix, Arizona, United States, 85053
KalVista Investigative Site
Tucson, Arizona, United States, 85704
United States, California
KalVista Investigative Site
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
United States, Colorado
KalVista Investigative Site
Golden, Colorado, United States, 80401
United States, Florida
KalVista Investigative Site
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
United States, Georgia
KalVista Investigative Site
Augusta, Georgia, United States, 30909
KalVista Investigative Site
Marietta, Georgia, United States, 30060
United States, Indiana
KalVista Investigative Site
Indianapolis, Indiana, United States, 46290
United States, Massachusetts
KalVista Investigative Site
Boston, Massachusetts, United States, 02114
KalVista Investigative Site
Boston, Massachusetts, United States, 02215
United States, Nevada
KalVista Investigative Site
Henderson, Nevada, United States, 89052
United States, New York
KalVista Investigative Site
Lynbrook, New York, United States, 11563
KalVista Investigative Site
Rochester, New York, United States, 14459
United States, Ohio
KalVista Investigative Site
Cincinnati, Ohio, United States, 45219
United States, South Dakota
KalVista Investigative Site
Rapid City, South Dakota, United States, 57701
United States, Texas
KalVista Investigative Site
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
United States, Virginia
KalVista Investigative Site
Charlottesville, Virginia, United States, 22903
United States, Washington
KalVista Investigative Site
Silverdale, Washington, United States, 98383
Sponsors and Collaborators
KalVista Pharmaceuticals, Ltd.
Investigators
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Study Director: Study Director KalVista Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by KalVista Pharmaceuticals, Ltd.:
Study Protocol  [PDF] April 9, 2018
Statistical Analysis Plan  [PDF] November 7, 2019

More Information
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Responsible Party: KalVista Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT03466099    
Other Study ID Numbers: KVD001-201
First Posted: March 15, 2018    Key Record Dates
Results First Posted: December 8, 2020
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases