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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: Completed Phase 1 study of Diabetic Macular Edema, sponsored by KalVista Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-07-18 |
| Est. Completion | 2015-06-04 |
| Phase | Phase 1 |
What the finished NCT02193113 record still lists
NCT02193113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (100% lower).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
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Where NCT02193113's enrollment target sits among peer trials
14 58th of 63 higher than 6 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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