CHAMP: Study of NVK-002 in Children With Myopia

A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia

Stage 1: To evaluate the safety and efficacy of 2 concentrations of NVK-002 compared to Vehicle (placebo) for slowing the progression of myopia in children over a 3 year treatment period.

Stage 2: To observe safety and efficacy in subjects re-randomized to one (1) year of treatment with NVK-002 or Vehicle following 3 years of treatment in children with progressive myopia.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Drug: NVK-002 Concentration 1; Drug: NVK-002 Concentration 2; Drug: Placebo

Detailed Description

This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages.

Stage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be allocated to 1 of 3 study medications.

Stage 2 is a randomized follow-up phase of 1 year in duration, during which subjects will be re-randomized to receive 1 of the 3 study medications, with subjects initially randomized to Vehicle only eligible for randomization to low or high-dose NVK-002.

Treatment arms are:

• NVK-002 low dose concentration
• NVK-002 high dose concentration
• Vehicle (placebo)

• Study Type: Interventional
• Enrollment (Actual): 670
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, H - 1085
    • Site #104
• Ireland
  • Dublin, Ireland, D07 H6K8
    • Site #101
• Netherlands
  • Rotterdam, Netherlands, 3015 AA
    • Site # 105
• Spain
  • Barcelona, Spain, 8950
    • Site #107
• United Kingdom
  • Coleraine, United Kingdom, BT52 1HS
    • Site #103
  • London, United Kingdom, EC1V 2PD
    • Site #106
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Site #009
  • California
    • Berkeley, California, United States, 94720
      • Site #015
    • Fullerton, California, United States, 92831
      • Site #003
    • San Diego, California, United States, 92129
      • Site #016
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Site #005
  • Florida
    • Maitland, Florida, United States, 32751
      • Site #004
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Site #024
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Site #006
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Site #014
  • New York
    • New York, New York, United States, 10036
      • Site #002
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • Site #013
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Site #001
  • Oregon
    • Forest Grove, Oregon, United States, 97116
      • Site #018
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States, 19027
      • Site #011
    • Lancaster, Pennsylvania, United States, 17601
      • Site #017
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Site #008
  • Texas
    • San Antonio, Texas, United States, 78240
      • Site #007
  • Washington
    • Kirkland, Washington, United States, 98034
      • Site #012
    • Spokane, Washington, United States, 99204
      • Site #020
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Site #021

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children aged 3 to ≤ 17.0 years.
2. Myopia SER of at least -0.50 D and no worse than -6.00 D myopia in each eye as measured by cycloplegic autorefraction.

Exclusion Criteria:

1. If present, astigmatism more than -1.50 D in either eye.
2. Current or history of amblyopia or strabismus.
3. History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
4. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia).
5. Serious systemic illness that, in the Investigator's opinion, would render the subject ineligible.
6. Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over the-counter) other than the assigned study medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NVK-002 Concentration 1; Stage 1: Subjects will be randomized to NVK-002 Concentration 1 Stage 2: Subjects will be re-randomized to one of the three treatment arms.	Drug: NVK-002 Concentration 1; Study medication will be administered, once daily (QD); Other Names: NVK-002 Conc 1
Experimental: NVK-002 Concentration 2; Stage 1: Subjects will be randomized to NVK-002 Concentration 2 Stage 2: Subjects will be re-randomized to one of the three treatment arms.	Drug: NVK-002 Concentration 2; Study medication will be administered, once daily (QD); Other Names: NVK-002 Conc 2
Placebo Comparator: Vehicle (Placebo); Stage 1: Subjects will be randomized to Vehicle (Placebo) Stage 2: Subjects will be re-randomized to one of the two experimental NVK-002 treatment arms	Drug: Placebo; Vehicle (placebo) will be administered, once daily (QD); Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit	Number of subjects' eyes that show < 0.50 D myopia progression (SER, spherical equivalent refraction) at the Month 36 visit.	36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in SER (Spherical Equivalent Refraction)	Change from baseline in SER (spherical equivalent refraction).	Month 36

Collaborators and Investigators

• Sponsor: Vyluma, Inc.
• Collaborators: Syneos Health
• Investigators: Study Director: Houman Hemmati, MD, Nevakar, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): October 19, 2023

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: child, myopia, nearsightedness
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CP-NVK002-0001; 2018-001077-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No