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Completed

NCT Number: NCT03466099

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 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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

KalVista Investigative Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KVD001 Injection

Drug

Intravitreal KVD001 Injection

Other names: KVD001

Sham Procedure

Other

Sham Procedure

Primary outcomes

  1. BCVA

    Time frame: 16 weeks

    Change from Baseline in Best Corrected Visual Acuity (BCVA)

Secondary outcomes

  1. DRSS

    Time frame: 16 weeks

    Assessments of Diabetic Retinopathy Severity Score (DRSS, scale 10-85) to evaluate the percentage of eyes with a ≥2 step reduction in score from the baseline retinopathy severity as graded from fundus photography. Minimum and maximum values of the DRSS are 10 and 85, with the low end of the scale indicating absence of retinopathy which, as the score increases, so does the severity of the retinopathy such that a score of 85 is indicative of advanced proliferative diabetic retinopathy

  2. CST

    Time frame: 16 weeks

    Assessments of Central Subfold Thickness (CST) - analysis of covariance of change from baseline in the study eye at week 16

Sponsors and collaborators

Lead sponsor

KalVista Pharmaceuticals, Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2018
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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