Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)
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
1 other identifier
interventional
129
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2018
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2018
CompletedFirst Submitted
Initial submission to the registry
February 26, 2018
CompletedFirst Posted
Study publicly available on registry
March 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2019
CompletedResults Posted
Study results publicly available
December 8, 2020
CompletedJanuary 28, 2021
January 1, 2021
1.6 years
February 26, 2018
October 8, 2020
January 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
BCVA
Change from Baseline in Best Corrected Visual Acuity (BCVA)
16 weeks
Secondary Outcomes (2)
DRSS
16 weeks
CST
16 weeks
Study Arms (3)
KVD001 Injection (high dose)
EXPERIMENTALKVD001 Injection (low dose)
EXPERIMENTALSham Procedure
SHAM COMPARATORInterventions
Intravitreal KVD001 Injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
KalVista Investigative Site
Phoenix, Arizona, 85021, United States
KalVista Investigative Site
Phoenix, Arizona, 85053, United States
KalVista Investigative Site
Tucson, Arizona, 85704, United States
KalVista Investigative Site
Arcadia, California, 91007, United States
KalVista Investigative Site
Beverly Hills, California, 90211, United States
KalVista Investigative Site
Palm Desert, California, 92260, United States
KalVista Investigative Site
Palo Alto, California, 94303, United States
KalVista Investigative Site
Sacramento, California, 95819, United States
KalVista Investigative Site
Santa Ana, California, 92705, United States
KalVista Investigative Site
Tustin, California, 92780, United States
KalVista Investigative Site
Golden, Colorado, 80401, United States
KalVista Investigative Site
Fort Myers, Florida, 33912, United States
KalVista Investigative Site
Miami, Florida, 33126, United States
KalVista Investigative Site
Miami, Florida, 33143, United States
KalVista Investigative Site
Pensacola, Florida, 32503, United States
KalVista Investigative Site
Winter Haven, Florida, 33880, United States
KalVista Investigative Site
Augusta, Georgia, 30909, United States
KalVista Investigative Site
Marietta, Georgia, 30060, United States
KalVista Investigative Site
Indianapolis, Indiana, 46290, United States
KalVista Investigative Site
Boston, Massachusetts, 02114, United States
KalVista Investigative Site
Boston, Massachusetts, 02215, United States
KalVista Investigative Site
Henderson, Nevada, 89052, United States
KalVista Investigative Site
Lynbrook, New York, 11563, United States
KalVista Investigative Site
Rochester, New York, 14459, United States
KalVista Investigative Site
Cincinnati, Ohio, 45219, United States
KalVista Investigative Site
Rapid City, South Dakota, 57701, United States
KalVista Investigative Site
Abilene, Texas, 79606, United States
KalVista Investigative Site
Arlington, Texas, 76012, United States
KalVIsta Investigative Site
Austin, Texas, 78705, United States
KalVista Investigative Site
Dallas, Texas, 75231, United States
KalVista Investigative Site
Fort Worth, Texas, 76102, United States
KalVista Investigative Site
San Antonio, Texas, 78240-1502, United States
KalVista Investigative Site
San Antonio, Texas, 78240, United States
KalVista Investigative Site
Charlottesville, Virginia, 22903, United States
KalVista Investigative Site
Silverdale, Washington, 98383, United States
Results Point of Contact
- Title
- Director Clinical
- Organization
- KalVista Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Study Director
KalVista Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2018
First Posted
March 15, 2018
Study Start
February 16, 2018
Primary Completion
October 10, 2019
Study Completion
October 10, 2019
Last Updated
January 28, 2021
Results First Posted
December 8, 2020
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share