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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001077-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVK-002 Concentration 1 | Drug | Study medication will be administered, once daily (QD) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in SER (Spherical Equivalent Refraction) | Change from baseline in SER (spherical equivalent refraction). | Month 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Houman Hemmati, MD | Nevakar, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #009 | Tucson | Arizona | 85711 | United States | ||
| Site #015 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41949794 | Derived | Zadnik K, Schulman E, Flitcroft I, Fogt JS, Blumenfeld LC, Fong TM, Lang E, Chandler SP, Hemmati HD; CHAMP trial Group Investigators. Negligible Rebound in Myopia Progression Following Cessation of Treatment with 0.01% Atropine for 3 years: Year-4 Results from the CHAMP Phase 3 Clinical Trial. Ophthalmic Physiol Opt. 2026 Apr 8. doi: 10.1007/s44402-026-00064-w. Online ahead of print. | |
| 37261839 |
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Enrolled subjects who did not meet the inclusion criteria or met the exclusion criteria were not randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. NVK-002 Concentration 1: Study medication will be administered, once daily (QD) |
| FG001 | NVK-002 Concentration 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2021 | Jul 22, 2024 |
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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.
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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.
| NVK-002 Concentration 2 | Drug | Study medication will be administered, once daily (QD) |
|
|
| Placebo | Drug | Vehicle (placebo) will be administered, once daily (QD) |
|
|
| Berkeley |
| California |
| 94720 |
| United States |
| Site #003 | Fullerton | California | 92831 | United States |
| Site #016 | San Diego | California | 92129 | United States |
| Site #005 | Danbury | Connecticut | 06810 | United States |
| Site #004 | Maitland | Florida | 32751 | United States |
| Site #024 | Peoria | Illinois | 61615 | United States |
| Site #006 | Boston | Massachusetts | 02115 | United States |
| Site #014 | St Louis | Missouri | 63110 | United States |
| Site #002 | New York | New York | 10036 | United States |
| Site #013 | Raleigh | North Carolina | 27603 | United States |
| Site #001 | Columbus | Ohio | 43210 | United States |
| Site #018 | Forest Grove | Oregon | 97116 | United States |
| Site #011 | Elkins Park | Pennsylvania | 19027 | United States |
| Site #017 | Lancaster | Pennsylvania | 17601 | United States |
| Site #008 | Memphis | Tennessee | 38104 | United States |
| Site #007 | San Antonio | Texas | 78240 | United States |
| Site #012 | Kirkland | Washington | 98034 | United States |
| Site #020 | Spokane | Washington | 99204 | United States |
| Site #021 | Madison | Wisconsin | 53705 | United States |
| Site #104 | Budapest | H - 1085 | Hungary |
| Site #101 | Dublin | D07 H6K8 | Ireland |
| Site # 105 | Rotterdam | 3015 AA | Netherlands |
| Site #107 | Barcelona | 8950 | Spain |
| Site #103 | Coleraine | BT52 1HS | United Kingdom |
| Site #106 | London | EC1V 2PD | United Kingdom |
| Derived |
| 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. |
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. NVK-002 Concentration 2: Study medication will be administered, once daily (QD) |
| FG002 | 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 Placebo: Vehicle (placebo) will be administered, once daily (QD) |
| COMPLETED |
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| NOT COMPLETED |
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| Stage 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. NVK-002 Concentration 1: Study medication will be administered, once daily (QD) |
| BG001 | 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. NVK-002 Concentration 2: Study medication will be administered, once daily (QD) |
| BG002 | 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 Placebo: Vehicle (placebo) will be administered, once daily (QD) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| SER | Median | Inter-Quartile Range | Diopter |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT | Posted | Number | participants' eyes | 36 Months | participants' eyes | participants' eyes |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SER (Spherical Equivalent Refraction) | Change from baseline in SER (spherical equivalent refraction). | ITT | Posted | Median | Inter-Quartile Range | Diopter | Month 36 | Participants' eyes | Participants' eyes |
|
3 years (Stage 1) and 1 year (Stage 2)
Treatment-emergent adverse events (TEAEs) are defined as any new or worsening of existing adverse events that occur or worsen between the first dose date of a specific stage and the last dose date of the same stage.
All-cause mortality, serious AE and other AE reporting are based on the Safety Set. The Safety Set (SS) will include all subjects who were administered at least one dose of study medication in Stage 1 or Stage 2.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage 1: NVK-002 Concentration 1 | Stage 1: Subjects randomized to NVK-002 Concentration 1 NVK-002 Concentration 1: Study medication will be administered, once daily (QD) | 0 | 164 | 1 | 164 | 56 | 164 |
| EG001 | Stage 1: NVK-002 Concentration 2 | Stage 1: Subjects randomized to NVK-002 Concentration 2 NVK-002 Concentration 2: Study medication will be administered, once daily (QD) | 0 | 247 | 8 | 247 | 92 | 247 |
| EG002 | Stage 1: Vehicle (Placebo) | Stage 1: Subjects randomized to Vehicle (Placebo) Placebo: Vehicle (placebo) will be administered, once daily (QD). Note: N=162 for the safety set (see comment in participant flow) | 0 | 162 | 4 | 162 | 75 | 162 |
| EG003 | Stage 2: NVK-002 Concentration 1 | Stage 2: Subjects randomized to NVK-002 Concentration 1 include those from Stage 1 NVK-002 concentration, Stage 1 NVK-002 concentration 2 and Stage 1 Vehicle (Placebo). | 0 | 159 | 3 | 159 | 43 | 159 |
| EG004 | Stage 2: NVK-002 Concentration 2 | Stage 2: Subjects randomized to NVK-002 Concentration 2 include those from Stage 1 NVK-002 concentration 1, NVK-002 concentration 2, and Stage 1 Vehicle (Placebo). | 0 | 162 | 2 | 162 | 29 | 162 |
| EG005 | Stage 2: Vehicle (Placebo) | Stage 2: Subjects randomized to Vehicle (Placebo) include those from Stage 1 NVK-002 concentration 1 and Stage 1 NVK-002 concentration 2. | 0 | 99 | 2 | 99 | 17 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| COVIV-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Parainfluenza | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Anal fisuure | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| suicidal ideation | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
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| suicide attempt | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
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| seizure | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
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| developmental hip dysplasia | Congenital, familial and genetic disorders | MedDRA 25.0 | Non-systematic Assessment |
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| brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
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| cholecystitis | Hepatobiliary disorders | MedDRA 25.0 | Non-systematic Assessment |
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| rectal hemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Disruptive mood dysregulation disorder | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Ankle fracture | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| influenza | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| hordeolum | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| ocular hyperemia | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
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| headache | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| seasonal allergy | Immune system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| pyrexia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Clinical Development | Vyluma, Inc | 9083677400 | info@vyluma.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 24, 2022 | Jan 3, 2023 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lost to Follow-up |
|
| unable to visit (1); used prohibited concomitant medication / withdrew consent (4); relocation (1). |
|
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
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| Units | Counts |
|---|
| Participants |
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| Participants' eyes |
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|