Clinical trial NCT03466099: Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: KalVista Pharmaceuticals, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-15
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: BCVA
timeFrame: 16 weeks
Secondary outcomes:
measure: DRSS
timeFrame: 16 weeks
measure: CST
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: KalVista Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: KalVista Investigative Site
state: Arizona
city: Tucson
country: United States
facility: KalVista Investigative Site
state: Arizona
city: Arcadia
country: United States
facility: KalVista Investigative Site
state: California
city: Beverly Hills
country: United States
facility: KalVista Investigative Site
state: California
city: Palm Desert
country: United States
facility: KalVista Investigative Site
state: California
city: Palo Alto
country: United States
facility: KalVista Investigative Site
state: California
city: Sacramento
country: United States
facility: KalVista Investigative Site
state: California
city: Santa Ana
country: United States
facility: KalVista Investigative Site
state: California
city: Tustin
country: United States
facility: KalVista Investigative Site
state: California
city: Golden
country: United States
facility: KalVista Investigative Site
state: Colorado
city: Fort Myers
country: United States
facility: KalVista Investigative Site
state: Florida
city: Miami
country: United States
facility: KalVista Investigative Site
state: Florida
city: Miami
country: United States
facility: KalVista Investigative Site
state: Florida
city: Pensacola
country: United States
facility: KalVista Investigative Site
state: Florida
city: Winter Haven
country: United States
facility: KalVista Investigative Site
state: Florida
city: Augusta
country: United States
facility: KalVista Investigative Site
state: Georgia
city: Marietta
country: United States
facility: KalVista Investigative Site
state: Georgia
city: Indianapolis
country: United States
facility: KalVista Investigative Site
state: Indiana
city: Boston
country: United States
facility: KalVista Investigative Site
state: Massachusetts
city: Boston
country: United States
facility: KalVista Investigative Site
state: Massachusetts
city: Henderson
country: United States
facility: KalVista Investigative Site
state: Nevada
city: Lynbrook
country: United States
facility: KalVista Investigative Site
state: New York
city: Rochester
country: United States
facility: KalVista Investigative Site
state: New York
city: Cincinnati
country: United States
facility: KalVista Investigative Site
state: Ohio
city: Rapid City
country: United States
facility: KalVista Investigative Site
state: South Dakota
city: Abilene
country: United States
facility: KalVista Investigative Site
state: Texas
city: Arlington
country: United States
facility: KalVista Investigative Site
state: Texas
city: Austin
country: United States
facility: KalVIsta Investigative Site
state: Texas
city: Dallas
country: United States
facility: KalVista Investigative Site
state: Texas
city: Fort Worth
country: United States
facility: KalVista Investigative Site
state: Texas
city: San Antonio
country: United States
facility: KalVista Investigative Site
state: Texas
city: San Antonio
country: United States
facility: KalVista Investigative Site
state: Texas
city: Charlottesville
country: United States
facility: KalVista Investigative Site
state: Virginia
city: Silverdale
country: United States
facility: KalVista Investigative Site
state: Washington
Study officials:
affiliation: KalVista Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References: