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NCT03466099 · ClinicalTrials.gov registry record · Phase 2
Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)
A Phase 2 study of Diabetic Macular Edema, sponsored by KalVista Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
- 20
- Study locations
NCT03466099: Completed Phase 2 study of Diabetic Macular Edema, sponsored by KalVista Pharmaceuticals.
NCT03466099 is a Phase 2 study of Diabetic Macular Edema that has completed, run by KalVista Pharmaceuticals. The registered enrollment target is 129 participants, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03466099, a Phase 2 study of Diabetic Macular Edema, has completed, sponsored by KalVista Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a clinical study where patients with diabetes and a vision threatening eye condition called "Diabetic Macular Edema" receive four injections into the eye at monthly intervals. The patients will already have tried the standard of care without complete success. The patients will be randomized to receive either a high dose, a low dose or a sham control treatment. The study will evaluate whether the new treatment improves vision and whether it changes the underlying course of the disease in the eye.
Primary Outcome
Change from Baseline in Best Corrected Visual Acuity (BCVA)
Conditions Studied
Interventions
- OTHER Sham Procedure
- DRUG KVD001 Injection
Study Locations (20)
California
- KalVista Investigative Site - Arcadia
- KalVista Investigative Site - Beverly Hills
- KalVista Investigative Site - Palm Desert
- KalVista Investigative Site - Palo Alto
- KalVista Investigative Site - Sacramento
- KalVista Investigative Site - Santa Ana
- KalVista Investigative Site - Tustin
Florida
- KalVista Investigative Site - Fort Myers
- KalVista Investigative Site - Miami
- KalVista Investigative Site - Miami
- KalVista Investigative Site - Pensacola
- KalVista Investigative Site - Winter Haven
Arizona
- KalVista Investigative Site - Phoenix
- KalVista Investigative Site - Phoenix
- KalVista Investigative Site - Tucson
Georgia
- KalVista Investigative Site - Augusta
- KalVista Investigative Site - Marietta
Colorado
- KalVista Investigative Site - Golden
Indiana
- KalVista Investigative Site - Indianapolis
Massachusetts
- KalVista Investigative Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2018-02-16 |
| Est. Completion | 2019-10-10 |
| Phase | Phase 2 |
What the finished NCT03466099 record still lists
NCT03466099 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 2 interventions - of which Sham Procedure is the first listed.
NCT03466099 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03466099 about?
NCT03466099 is a clinical study titled "Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)". This is a clinical study where patients with diabetes and a vision threatening eye condition called "Diabetic Macular Edema" receive four injections into the eye at monthly intervals. The patients will already have tried the standard of care without complete success. The patients will be randomized ...
What is the current status of trial NCT03466099?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2018-02-16. Estimated completion is 2019-10-10.
What conditions does trial NCT03466099 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT03466099?
The interventions under investigation include: Sham Procedure (OTHER), KVD001 Injection (DRUG).
Who is sponsoring clinical trial NCT03466099?
This trial is sponsored by KalVista Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03466099 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03466099's enrollment target sits among peer trials
129 28th of 63 higher than 36 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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