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NCT02193113 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Diabetic Macular Edema, sponsored by KalVista Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target
5
Study locations

NCT02193113 is a Phase 1 study of Diabetic Macular Edema that has completed, run by KalVista Pharmaceuticals. The registered enrollment target is 14 participants, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (100% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT02193113, a Phase 1 study of Diabetic Macular Edema, has completed, sponsored by KalVista Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target
5
Study locations

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 Studied

Interventions

  • DRUG KVD001 Injection

Study Locations (5)

California

  • Retina Vitreous Associates Medical Group - Beverly Hills

Indiana

  • Raj K. Maturi, MD PC - Indianapolis

Massachusetts

  • Beetham Eye Institute - Boston

South Carolina

  • Palmetto Retina Center - West Columbia

Texas

  • Valley Retina Institute, PA - McAllen

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2014-07-18
Est. Completion 2015-06-04
Phase Phase 1

Sponsor

KalVista Pharmaceuticals

9 total trials

What the Registry Record Tells You About NCT02193113

The ClinicalTrials.gov registry entry for NCT02193113 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (100% lower). The listed sponsor is KalVista Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which KVD001 Injection is the first listed.

NCT02193113 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Indiana, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02193113 about?

NCT02193113 is a clinical study titled "A Phase I Single Ascending Dose Study of the Intravitreal Plasma Kallikrein Inhibitor KVD001 in Subjects With DME". 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 ma...

What is the current status of trial NCT02193113?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2014-07-18. Estimated completion is 2015-06-04.

What conditions does trial NCT02193113 study?

This clinical trial studies the following conditions: Diabetic Macular Edema.

What interventions are being tested in trial NCT02193113?

The interventions under investigation include: KVD001 Injection (DRUG).

Who is sponsoring clinical trial NCT02193113?

This trial is sponsored by KalVista Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02193113 being conducted?

This trial has 5 study locations across California, Indiana, Massachusetts, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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