Status:
COMPLETED
Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)
Lead Sponsor:
KalVista Pharmaceuticals, Ltd.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wil...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Type I or Type II diabetes mellitus (DM).
- BCVA of ≥19 letters (\~20/400) and ≤73 letters (\~20/40) in the study eye and ≥34 letters(\~20/200 or better) in the fellow eye.
- Presence of ciDME in the study eye defined as CST ≥305 μm in women and ≥320 μm in men
- Subjects first anti-VEGF injection in the study eye occurred ≤36 months.
- Subjects have received at least 3 anti-vascular endothelial growth factor (VEGF) injections in the study eye within a 6-month period.
- The last anti-VEGF injection in the study eye is ≥ 8 weeks.
Exclusion
- Evidence of ocular pathology (e.g. visually significant cataract) that impacts subject's vision in the study eye from any cause other than DME.
- Evidence/presence of amblyopia, vitreomacular traction, epiretinal membrane, foveal atrophy, or foveal ischemia, or any other condition in the macula that is thought to impair the subject's vision (other than DME).
- Prior treatment with panretinal photocoagulation or focal grid macular photocoagulation in the study eye within the previous 3 months.
- Prior treatment with intravitreal (IVT) steroid in the study eye (in the previous 3 months for triamcinolone, previous 6 months for Ozurdex and at any time for Iluvien).
- Prior treatment with topical NSAIDs or topical steroids in the study eye within 1 month.
- Prior treatment with systemic corticosteroids or systemic anti-VEGF therapy within 3 months.
- Prior vitrectomy in the study eye.
- Prior intraocular surgery in the study eye except for cataract surgery. Cataract surgery within the previous 6 months in the study eye is excluded.
- Intraocular pressure (IOP) of \>22 mmHg in the study eye or use of \>2 antiglaucoma agents (combination agents count as 2 agents) in the study eye.
- Evidence of infectious dacrocystitis, significant blepharitis, active conjunctivitis, infectious keratitis, or scleritis in either eye, or any other condition that might affect the safety of the IVT injection.
- Current active proliferative diabetic retinopathy (PDR), active anterior segment neovascularization (ASNV), active retinal neovascularization, or the presence of vitreous hemorrhage in the study eye.
- Poorly controlled DM.
- Uncontrolled hypertension
- Prior treatment with ocriplasminin the study eye within 3 months
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2019
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03466099
Start Date
February 16 2018
End Date
October 10 2019
Last Update
January 28 2021
Active Locations (35)
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1
KalVista Investigative Site
Phoenix, Arizona, United States, 85021
2
KalVista Investigative Site
Phoenix, Arizona, United States, 85053
3
KalVista Investigative Site
Tucson, Arizona, United States, 85704
4
KalVista Investigative Site
Arcadia, California, United States, 91007