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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466099
• Other study ID #: KVD001-201
• Status: Completed
• Phase: Phase 2
• Start date: February 16, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: January 2021
• Source: KalVista Pharmaceuticals, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• KVD001 Injection
Intravitreal KVD001 Injection

Other:
• Sham Procedure
Sham Procedure

Locations

Country	Name	City	State
United States	KalVista Investigative Site	Abilene	Texas
United States	KalVista Investigative Site	Arcadia	California
United States	KalVista Investigative Site	Arlington	Texas
United States	KalVista Investigative Site	Augusta	Georgia
United States	KalVIsta Investigative Site	Austin	Texas
United States	KalVista Investigative Site	Beverly Hills	California
United States	KalVista Investigative Site	Boston	Massachusetts
United States	KalVista Investigative Site	Boston	Massachusetts
United States	KalVista Investigative Site	Charlottesville	Virginia
United States	KalVista Investigative Site	Cincinnati	Ohio
United States	KalVista Investigative Site	Dallas	Texas
United States	KalVista Investigative Site	Fort Myers	Florida
United States	KalVista Investigative Site	Fort Worth	Texas
United States	KalVista Investigative Site	Golden	Colorado
United States	KalVista Investigative Site	Henderson	Nevada
United States	KalVista Investigative Site	Indianapolis	Indiana
United States	KalVista Investigative Site	Lynbrook	New York
United States	KalVista Investigative Site	Marietta	Georgia
United States	KalVista Investigative Site	Miami	Florida
United States	KalVista Investigative Site	Miami	Florida
United States	KalVista Investigative Site	Palm Desert	California
United States	KalVista Investigative Site	Palo Alto	California
United States	KalVista Investigative Site	Pensacola	Florida
United States	KalVista Investigative Site	Phoenix	Arizona
United States	KalVista Investigative Site	Phoenix	Arizona
United States	KalVista Investigative Site	Rapid City	South Dakota
United States	KalVista Investigative Site	Rochester	New York
United States	KalVista Investigative Site	Sacramento	California
United States	KalVista Investigative Site	San Antonio	Texas
United States	KalVista Investigative Site	San Antonio	Texas
United States	KalVista Investigative Site	Santa Ana	California
United States	KalVista Investigative Site	Silverdale	Washington
United States	KalVista Investigative Site	Tucson	Arizona
United States	KalVista Investigative Site	Tustin	California
United States	KalVista Investigative Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
KalVista Pharmaceuticals, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA	Change from Baseline in Best Corrected Visual Acuity (BCVA)	16 weeks
Secondary	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	16 weeks
Secondary	CST	Assessments of Central Subfold Thickness (CST) - analysis of covariance of change from baseline in the study eye at week 16	16 weeks