Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia

A 52 Week Randomized, Single-masked, Multicenter Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia in Children 4-7 Years of Age With an Open-label Substudy of Binocular Videogames in Children 8-12 Years of Age

ClinicalTrials.gov Identifier: NCT04784390

Novartis Reference Number: CDDO001F12201

Last Update: Mar 11, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this PoC study is to evaluate the potential therapeutic efficacy of binocular video games played on a tablet and to compare the efficacy of binocular video games versus patching in amblyopic patients 4 to 7 years old (Part A) as well as to gain experience with binocular video games in older children population of 8 to12 years old (Part B).

Part A and Part B are designed to provide long term data on durability of binocular video games treatment.

Condition 
Amblyopia
Phase 
Phase 1
Overall status 
Recruiting
Start date 
Jun 30, 2021
Completion date 
Jun 29, 2023
Gender 
All
Age(s)
4 Years - 12 Years (Child)

Interventions

Device
Binocular video games
Patients will play 1 hour of binocular video game of choice (Dig Rush and/or Monster Burner) a day 7 days a week for 8 to 12 weeks.
Device
Patching of the sound eye
Patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks.

Eligibility Criteria

Inclusion Criteria:

Written informed consent must be signed by the parent(s) or legal guardian(s) prior to participation in the study.
Male or female children 4 to 7 years old at Screening (Part A) or 8 to 12 years old at Screening (Part B).
Diagnosis of amblyopia due to strabismus, anisometropia, or both.
Best corrected visual acuity (BCVA) of amblyopic eye (study eye) between 0.3 to 1.0 Logarithm of the Minimum Angle of Resolution (logMAR) (20/40 to 20/200 Snellen inclusive, 33 to 72 ETDRS letters inclusive) at Screening and Baseline.
BCVA of the sound eye (fellow eye) 0.1 logMAR (20/25 Snellen, 80 Early Treatment Diabetic Retinopathy Study (ETDRS) letters) or better in children 5 years of age and older or 0.2 logMAR (20/30 Snellen, 75 ETDRS letters) or better in children 4 years of age at Screening and Baseline.
Interocular difference of BCVA at least 0.3 logMAR (≥3 lines; ETDRS≥15 letters) at Baseline.
Patient is able to play the binocular game (Dig Rush and Monster Burner) on at least level 3 on the study tablet under binocular conditions (with red-green glasses).

Exclusion Criteria:

Treatment for amblyopia with patching, Bangerter filter, vision therapy, or binocular treatment in the past 1 week prior to Screening, or atropine in the past 4 weeks prior to Screening.
Treatment for amblyopia with patching, Bangerter filter, vision therapy, binocular treatment or atropine for more than 1 year prior to screening cumulatively.
Myopia ≥ -6.00D spheric equivalent in either eye at Screening or Baseline.
Prior amblyopia treatment (patching, Bangerter filter, vision therapy, binocular treatment or atropine) for more than a year prior to screening cumulatively.

Study Locations

United States
Novartis Investigative Site
Recruiting
Los Angeles, 90095
California
United States
Novartis Investigative Site
Recruiting
Santa Barbara, 93105
California
United States
Novartis Investigative Site
Recruiting
Gainesville, 32605
Florida
United States
Novartis Investigative Site
Recruiting
Maitland, 32751
Florida
United States
Novartis Investigative Site
Recruiting
Chicago, 60611
Illinois
United States
Novartis Investigative Site
Recruiting
Frederick, 21703
Maryland
United States
Novartis Investigative Site
Recruiting
Boston, 02115
Massachusetts
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63104
Missouri
United States
Novartis Investigative Site
Recruiting
Las Vegas, 98102
Nevada
United States
Novartis Investigative Site
Recruiting
Columbus, 43205
Ohio
United States
Novartis Investigative Site
Recruiting
Lancaster, 17601
Pennsylvania
United States
Australia
Novartis Investigative Site
Recruiting
North Ryde, 2109
New South Wales
Australia
Novartis Investigative Site
Recruiting
Sydney, 2052
New South Wales
Australia
Novartis Investigative Site
Recruiting
Westmead, 2145
-
Australia
Canada
Novartis Investigative Site
Recruiting
Kitchener, N2A 0K5
Ontario
Canada
Novartis Investigative Site
Recruiting
Waterloo, N2L3G1
Ontario
Canada

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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