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Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)

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ClinicalTrials.gov Identifier: NCT03466099
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
KalVista Pharmaceuticals, Ltd.

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: KVD001 Injection Other: Sham Procedure Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: KVD001 Injection (high dose) Drug: KVD001 Injection
Intravitreal KVD001 Injection
Other Name: KVD001
Experimental: KVD001 Injection (low dose) Drug: KVD001 Injection
Intravitreal KVD001 Injection
Other Name: KVD001
Sham Comparator: Sham Procedure Other: Sham Procedure
Sham Procedure


Outcome Measures
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Primary Outcome Measures :
  1. BCVA [ Time Frame: 16 weeks ]
    Assessment of Best Corrected Visual Acuity (BCVA)


Secondary Outcome Measures :
  1. DRSS [ Time Frame: 16 weeks ]
    Assessments of Diabetic Retinopathy Severity Score (DRSS)

  2. CST [ Time Frame: 16 weeks ]
    Assessments of Central Subfold Thickness (CST)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466099


Contacts
Contact: KalVista Pharmaceuticals 1 (857) 999-0075 KVD001@kalvista.com

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Sponsors and Collaborators
KalVista Pharmaceuticals, Ltd.
Investigators
Study Director: Study Director KalVista Pharmaceuticals
More Information
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Responsible Party: KalVista Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT03466099     History of Changes
Other Study ID Numbers: KVD001-201
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Endothelial Growth Factors
 Kallikreins
Plasma Kallikrein
Growth Substances
Physiological Effects of Drugs
Coagulants
Fertility Agents, Male
Fertility Agents
Reproductive Control Agents