CHAMP: Study of NVK-002 in Children With Myopia

NCT03350620 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CP-NVK002-00012018-001077-24
• Study Type: interventional
• Target: 670
• Locations: 6 countries
• Sites: 26

Brief Summary

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.

Conditions

Myopia

Keywords

child, myopia, nearsightedness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in SER (Spherical Equivalent Refraction)

  Month 36

Study Arms (3)

NVK-002 Concentration 1

EXPERIMENTAL

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

NVK-002 Concentration 2

EXPERIMENTAL

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

Vehicle (Placebo)

PLACEBO COMPARATOR

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

Interventions

NVK-002 Concentration 1 DRUG

Study medication will be administered, once daily (QD)

Also known as: NVK-002 Conc 1

NVK-002 Concentration 1

NVK-002 Concentration 2 DRUG

Study medication will be administered, once daily (QD)

Also known as: NVK-002 Conc 2

NVK-002 Concentration 2

Placebo DRUG

Vehicle (placebo) will be administered, once daily (QD)

Also known as: Vehicle

Vehicle (Placebo)

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vyluma, Inc.: lead
• Syneos Health: collaborator

Study Sites (26)

Site #009

Tucson, Arizona, 85711, United States

Location

Site #015

Berkeley, California, 94720, United States

Location

Site #003

Fullerton, California, 92831, United States

Location

Site #016

San Diego, California, 92129, United States

Location

Site #005

Danbury, Connecticut, 06810, United States

Location

Site #004

Maitland, Florida, 32751, United States

Location

Site #024

Peoria, Illinois, 61615, United States

Location

Site #006

Boston, Massachusetts, 02115, United States

Location

Site #014

St Louis, Missouri, 63110, United States

Location

Site #002

New York, New York, 10036, United States

Location

Site #013

Raleigh, North Carolina, 27603, United States

Location

Site #001

Columbus, Ohio, 43210, United States

Location

Site #018

Forest Grove, Oregon, 97116, United States

Location

Site #011

Elkins Park, Pennsylvania, 19027, United States

Location

Site #017

Lancaster, Pennsylvania, 17601, United States

Location

Site #008

Memphis, Tennessee, 38104, United States

Location

Site #007

San Antonio, Texas, 78240, United States

Location

Site #012

Kirkland, Washington, 98034, United States

Location

Site #020

Spokane, Washington, 99204, United States

Location

Site #021

Madison, Wisconsin, 53705, United States

Location

Site #104

Budapest, H - 1085, Hungary

Location

Site #101

Dublin, D07 H6K8, Ireland

Location

Site # 105

Rotterdam, 3015 AA, Netherlands

Location

Site #107

Barcelona, 8950, Spain

Location

Site #103

Coleraine, BT52 1HS, United Kingdom

Location

Site #106

London, EC1V 2PD, United Kingdom

Location

Related Publications (1)

• Zadnik K, Schulman E, Flitcroft I, Fogt JS, Blumenfeld LC, Fong TM, Lang E, Hemmati HD, Chandler SP; CHAMP Trial Group Investigators. Efficacy and Safety of 0.01% and 0.02% Atropine for the Treatment of Pediatric Myopia Progression Over 3 Years: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Oct 1;141(10):990-999. doi: 10.1001/jamaophthalmol.2023.2097.

  PMID: 37261839 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: VP of Clinical Development
• Organization: Vyluma, Inc

info@vyluma.com

9083677400

Study Officials

• Houman Hemmati, MD

  Nevakar, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: If subjects meet eligibility criteria at the Screening/Baseline visit (Day 0), subjects will be randomly assigned to masked study medication. The study will be double masked. The study medication will be provided in identical-appearing laminated pouches with no labeling indicating the identity of the study group or the contents of the ampules. The laminated pouches will contain identical-appearing ampules. Study subjects and study management personnel will be masked to the identity of treatment until after the final database lock.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages. Stage 1 is to assess the primary and secondary endpoints. Stage 2 is an extension stage for exploratory endpoints. 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 cross-over 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.

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 22, 2017
• Study Start: November 20, 2017
• Primary Completion: September 7, 2022
• Study Completion: October 19, 2023
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IE (1); NL (1); HU (1); US (20); GB (2)