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

NCT02193113 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-03-03

No results posted yet for this study

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

Interventions

DRUG

KVD001 Injection

A novel plasma kallikrein inhibitor

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • KalVista Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Jennifer Sun, MD, MPH · Joslin Diabetes Center

  • David Boyer, MD · Retina-Vitreous Associates Medical Group

  • Victor Gonzalez, MD · Valley Retina Institute, PA

  • Raj Maturi, MD · Midwest Eye Institute

  • Jack Wells, MD · Palmetto Retina Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-18
Primary Completion
2015-06-04
Completion
2015-06-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02193113 on ClinicalTrials.gov