Trials / Completed
CompletedNCT03466099
Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)
A Randomized Sham-controlled Double-masked Phase 2a Study of the Efficacy, Safety and Tolerability of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema Who Have Had Prior Anti-vascular Endothelial Growth Factor Treatment
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- KalVista Pharmaceuticals, Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KVD001 Injection | Intravitreal KVD001 Injection |
| OTHER | Sham Procedure | Sham Procedure |
Timeline
- Start date
- 2018-02-16
- Primary completion
- 2019-10-10
- Completion
- 2019-10-10
- First posted
- 2018-03-15
- Last updated
- 2021-01-28
- Results posted
- 2020-12-08
Locations
35 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03466099. Inclusion in this directory is not an endorsement.