Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

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

NCT02193113 · View on ClinicalTrials.gov ↗

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

5 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02193113

The ClinicalTrials.gov registry entry for NCT02193113 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is KalVista Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02193113 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Indiana, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02193113?

The interventions under investigation include: KVD001 Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02193113?

This trial is sponsored by KalVista Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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