CHAMP: Study of NVK-002 in Children With Myopia
Primary Purpose
Myopia
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NVK-002 Concentration 1
NVK-002 Concentration 2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring child, myopia, nearsightedness
Eligibility Criteria
Inclusion Criteria:
- Children aged 3 to ≤ 17.0 years.
- 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:
- 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.
Sites / Locations
- Site #009
- Site #015
- Site #003
- Site #016
- Site #005
- Site #004
- Site #024
- Site #006
- Site #014
- Site #002
- Site #013
- Site #001
- Site #018
- Site #011
- Site #017
- Site #008
- Site #007
- Site #012
- Site #020
- Site #021
- Site #104
- Site #101
- Site # 105
- Site #107
- Site #103
- Site #106
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
NVK-002 Concentration 1
NVK-002 Concentration 2
Vehicle (Placebo)
Arm Description
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.
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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Between-group difference in mean progression rates.
Between-group difference in mean progression rates.
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.
Full Information
NCT ID
NCT03350620
First Posted
November 16, 2017
Last Updated
January 3, 2023
Sponsor
Vyluma, Inc.
Collaborators
Syneos Health
1. Study Identification
Unique Protocol Identification Number
NCT03350620
Brief Title
CHAMP: Study of NVK-002 in Children With Myopia
Official Title
A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
August 7, 2023 (Anticipated)
Study Completion Date
August 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyluma, Inc.
Collaborators
Syneos Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
child, myopia, nearsightedness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model 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.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
576 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NVK-002 Concentration 1
Arm Type
Experimental
Arm Description
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.
Arm Title
NVK-002 Concentration 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Vehicle (Placebo)
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
NVK-002 Concentration 1
Other Intervention Name(s)
NVK-002 Conc 1
Intervention Description
Study medication will be administered, once daily (QD)
Intervention Type
Drug
Intervention Name(s)
NVK-002 Concentration 2
Other Intervention Name(s)
NVK-002 Conc 2
Intervention Description
Study medication will be administered, once daily (QD)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
Vehicle (placebo) will be administered, once daily (QD)
Primary Outcome Measure Information:
Title
The overall between-group difference in proportion of subjects who show < -0.50 D myopia progression (SER) at the Month 36 visit.
Description
The overall between-group difference in proportion of subjects who show < -0.50 D myopia progression (SER) at the Month 36 visit.
Time Frame
36 Months
Secondary Outcome Measure Information:
Title
Between-group difference in mean progression rates.
Description
Between-group difference in mean progression rates.
Time Frame
Month 12, Month 24, Month 36
Title
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.
Description
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.
Time Frame
Month 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 3 to ≤ 17.0 years.
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Houman Hemmati, MD
Organizational Affiliation
Nevakar, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site #009
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Site #015
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States
Facility Name
Site #003
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Facility Name
Site #016
City
San Diego
State/Province
California
ZIP/Postal Code
92129
Country
United States
Facility Name
Site #005
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Site #004
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Site #024
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Site #006
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Site #014
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site #002
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Site #013
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Site #001
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Site #018
City
Forest Grove
State/Province
Oregon
ZIP/Postal Code
97116
Country
United States
Facility Name
Site #011
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
Site #017
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Site #008
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Site #007
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Site #012
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Site #020
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Site #021
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Site #104
City
Budapest
ZIP/Postal Code
H - 1085
Country
Hungary
Facility Name
Site #101
City
Dublin
ZIP/Postal Code
D07 H6K8
Country
Ireland
Facility Name
Site # 105
City
Rotterdam
ZIP/Postal Code
3015 AA
Country
Netherlands
Facility Name
Site #107
City
Barcelona
ZIP/Postal Code
8950
Country
Spain
Facility Name
Site #103
City
Coleraine
ZIP/Postal Code
BT52 1HS
Country
United Kingdom
Facility Name
Site #106
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CHAMP: Study of NVK-002 in Children With Myopia
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