A Phase I Single Ascending Dose Study of the Intravitreal Plasma Kallikrein Inhibitor KVD001 in Subjects With DME

NCT02193113 | Completed Phase 1 DMC

• 1 other identifier: KVD001-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

Brief Summary

This is a Phase 1 study to investigate the safety, tolerability of the novel plasma kallikrein inhibitor, KVD001 in subjects with diabetic macular edema. The study is the first step to investigate the hypothesis that plasma kallikrein plays an important role in the disease process behind diabetic macular edema in many patients

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema; DME; Plasma Kallikrein inhibitor; KVD001; KVD001-001; Intravitreal; IVT; Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events as a measure of safety and tolerability

  56 days

Secondary Outcomes (2)

• Measurement of KVD001 plasma levels over time following intravitreal injection (with calculation of Tmax, Cmax, AUC and t1/2)

  28 days

• Best Corrected Visual Acuity as measured by ETDRS EVA

  56 days

Other Outcomes (1)

• Change in retinal thickness from baseline

  84 days

Study Arms (3)

KVD001 Injection Dose 1

EXPERIMENTAL

Single 100 microliters (uL) intravitreal injection of KVD001 Injection Dose 1

Drug: KVD001 Injection

KVD001 Injection Dose 2

EXPERIMENTAL

Single 100uL intravitreal injection KVD001 injection Dose 2

Drug: KVD001 Injection

KVD001 Injection Dose 3

EXPERIMENTAL

Single 100uL intravitreal injection of KVD001 injection Dose 3

Drug: KVD001 Injection

Interventions

KVD001 Injection DRUG

A novel plasma kallikrein inhibitor

Also known as: KVD001

KVD001 Injection Dose 1; KVD001 Injection Dose 2; KVD001 Injection Dose 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult subjects 18 years of age and older
• Confirmed diagnosis of Type I or Type II diabetes mellitus
• Best corrected visual acuity, using Early Treatment Diabetic Retinopathy Study (ETDRS) electronic visual acuity (EVA) testing, of between 20/40 and 20/400 (Snellen equivalent) in the study eye
• Fellow eye acuity 20/80 or better measured as above with no expectation of requirement for anti-VEGF treatment in fellow eye within 2 months of study drug administration
• Presence of central involved DME in the study eye defined as Optical Coherence Tomography (OCT) Central Subfold Thickness (CST) ≥305 µm in women and ≥320 µm in men in the study eye
• Subjects who fulfil one of the following criteria:
• Subjects who have not previously received an anti-VEGF treatment and who, in the view of the Investigator, can have initiation of anti-VEGF treatment in the study eye deferred for at least 2 months following the date of anticipated study drug administration
• Subjects who are receiving regular anti-VEGF intravitreal injections who:
• Have received at least 3 intravitreal injections of an anti-VEGF treatment within the last 5 months (study drug administration will be at least 6 weeks after the most recent intravitreal administration of anti-VEGF) and
• In the view of the Investigator, can have continuation of anti-VEGF treatment in the study eye deferred for at least 2 months following the date of anticipated study drug administration
• Subjects, who in the view of the Investigator, are not expected to require panretinal laser photocoagulation or intravitreal steroids or intraocular surgery in the study eye for at least 2 months following anticipated study drug administration
• No prior treatment with panretinal photocoagulation or intravitreal steroid in the study eye within the previous 3 months
• No prior treatment with systemic corticosteroids or systemic anti-VEGF therapy within the previous 3 months
• Study participant voluntarily agrees to participate in this study and signs the Institutional Review Board (IRB) approved informed consent prior to performing any procedure

You may not qualify if:

• Females who are pregnant or lactating, or expecting to become pregnant during the course of the study
• Poorly controlled diabetes mellitus
• Uncontrolled hypertension
• Significant co-existing disease
• History of alcohol and/or drug abuse in the last 2 years
• Men not willing to use appropriate birth control methods
• Media clarity or pupillary dilation inadequate to obtain reasonable quality OCT and/or fundus image
• Subjects employed by the Sponsor or in any relationship of dependence with the Sponsor and/or Investigator

Sponsors & Collaborators

• KalVista Pharmaceuticals, Ltd.: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (5)

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Raj K. Maturi, MD PC

Indianapolis, Indiana, 46290, United States

Location

Beetham Eye Institute

Boston, Massachusetts, 02215, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Related Links

• Sponsor's Website (KalVista Pharmaceuticals)

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jennifer Sun, MD, MPH

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

• David Boyer, MD

  Retina-Vitreous Associates Medical Group

  PRINCIPAL INVESTIGATOR

• Victor Gonzalez, MD

  Valley Retina Institute, PA

  PRINCIPAL INVESTIGATOR

• Raj Maturi, MD

  Midwest Eye Institute

  PRINCIPAL INVESTIGATOR

• Jack Wells, MD

  Palmetto Retina Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 17, 2014
• Study Start: July 18, 2014
• Primary Completion: June 4, 2015
• Study Completion: June 4, 2015
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)