CHAMP: Study of NVK-002 in Children With Myopia

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03350620
• Other study ID #: CP-NVK002-0001
• Secondary ID: 2018-001077-24
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 20, 2017
• Est. completion date: August 7, 2023

Study information

• Verified date: January 2023
• Source: Nevakar, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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. Treatment arms are: - NVK-002 low dose concentration - NVK-002 high dose concentration - Vehicle (placebo)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 576
• Est. completion date: August 7, 2023
• Est. primary completion date: August 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Children aged 3 to = 17.0 years.

2. Myopia SER of at least -0.50 D and no greater 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.

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• NVK-002 Concentration 1
Study medication will be administered, once daily (QD)
• NVK-002 Concentration 2
Study medication will be administered, once daily (QD)
• Placebo
Vehicle (placebo) will be administered, once daily (QD)

Locations

Country	Name	City	State
Hungary	Site #104	Budapest
Ireland	Site #101	Dublin
Netherlands	Site # 105	Rotterdam
Spain	Site #107	Barcelona
United Kingdom	Site #103	Coleraine
United Kingdom	Site #106	London
United States	Site #015	Berkeley	California
United States	Site #006	Boston	Massachusetts
United States	Site #001	Columbus	Ohio
United States	Site #005	Danbury	Connecticut
United States	Site #011	Elkins Park	Pennsylvania
United States	Site #018	Forest Grove	Oregon
United States	Site #003	Fullerton	California
United States	Site #012	Kirkland	Washington
United States	Site #017	Lancaster	Pennsylvania
United States	Site #021	Madison	Wisconsin
United States	Site #004	Maitland	Florida
United States	Site #008	Memphis	Tennessee
United States	Site #002	New York	New York
United States	Site #024	Peoria	Illinois
United States	Site #013	Raleigh	North Carolina
United States	Site #014	Saint Louis	Missouri
United States	Site #007	San Antonio	Texas
United States	Site #016	San Diego	California
United States	Site #020	Spokane	Washington
United States	Site #009	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Vyluma, Inc.	Syneos Health

Countries where clinical trial is conducted

United States,  Hungary,  Ireland,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall between-group difference in proportion of subjects who show < -0.50 D myopia progression (SER) at the Month 36 visit.	The overall between-group difference in proportion of subjects who show < -0.50 D myopia progression (SER) at the Month 36 visit.	36 Months
Secondary	Between-group difference in mean progression rates.	Between-group difference in mean progression rates.	Month 12, Month 24, Month 36
Secondary	Between-group difference in proportion of subjects who show <-0.75 D progression and the between-group median time to a change in myopia of <-0.75 D.	Between-group difference in proportion of subjects who show <-0.75 D progression and the between-group median time to a change in myopia of <-0.75 D.	Month 36