search
Back to results

Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia

Primary Purpose

Amblyopia

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Binocular video games
Patching of the sound eye
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring DDO001, amblyopia, binocular video games, patching, eye disorder, lazy eye, unable to focus in one eye, eye muscle disorder, wandering eye, abnormal vision development

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent must be signed by the parent(s) or legal guardian(s) prior to participation in the study.
  2. Male or female children 4 to 7 years old at Screening (Part A) or 8 to 12 years old at Screening (Part B).
  3. Diagnosis of amblyopia due to strabismus, anisometropia, or both.
  4. 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.
  5. 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.
  6. Interocular difference of BCVA at least 0.3 logMAR (≥3 lines; ETDRS≥15 letters) at Baseline.
  7. 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:

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Patching

Binocular video games

Arm Description

Patching of the sound eye (fellow eye) - patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks.

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.

Outcomes

Primary Outcome Measures

Change in best corrected visual acuity (BCVA) in the amblyopic eye.
Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).

Secondary Outcome Measures

Attain BCVA of 0.1 logMAR or better in the amblyopic eye
Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).
Change in stereoacuity or binocular video game relative to patching.
Part A: Stereoacuity will be assessed at near using Randot Preschool Stereoacuity Test (Stereo Optical, Inc.). The test is performed using 3 stereotest booklets while wearing 3D glasses. In short, in each test booklet, the left-hand page shows two-dimensional black-and-white silhouettes of two sets (panels) of four test shapes. The right-hand page contains two sets of four random-dot patterns in different sequences that are on the left-hand page. In each set of random-dot patterns, one contains no test shape, while the remaining contains test shapes. The child must correctly identify at least two of the three test shapes at each disparity level.
Attain a 2-line or better improvement in BCVA in the amblyopic eye
Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).
Change in BCVA in the amblyopic eye
Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).
Frequency of treatment-emergent Adverse Events
Part A and B: An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical study subject, user or other person, after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of the study device, i.e., videogame system (tablet, software, 3D glasses) or patch.
Time played as recorded in the diary
Part A: To assess compliance with treatment
Time patched as recorded in the diary
Part A: To assess compliance with treatment
Time played as recorded in the video game system
Parts A and B: To assess compliance with treatment
Percentage of participants who complete at least 75% of prescribed game play
Parts A and B: To assess compliance with treatment

Full Information

First Posted
March 2, 2021
Last Updated
May 19, 2023
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT04784390
Brief Title
Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia
Official Title
A 16 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated based upon the competitive landscape and strategic fit.
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
August 3, 2022 (Actual)
Study Completion Date
August 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this PoC study was 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 was designed to provide long term data on durability of binocular video games treatment. The study consisted of two parts, Part A: randomized, single masked PoC study in children 4 to 7 years old at Screening, and Part B: open-label substudy in children 8 to 12 year old at Screening.
Detailed Description
The clinical investigation consisted of 2 parts: Part A: a single-masked, randomized clinical investigation in subjects 4 to 7 years of age. Part B: an open-label, non-randomized sub-investigation in subjects 8 to 12 years of age. Part A was a 16-week, prospective, randomized, single-masked, multicenter, controlled, 2 arm, parallel-group clinical investigation in subjects 4 to 7 years of age with amblyopia. Subjects were randomly assigned in a 1:1 ratio to either binocular videogame treatment for 8 to 12 weeks or patching treatment for 16 weeks. Randomization was stratified by severity of amblyopia in eligible subjects (moderate amblyopia with best-corrected visual acuity (BCVA) of the amblyopic eye of 20/100 or better, or severe amblyopia with BCVA of the amblyopic eye worse than 20/100). Part B was a 16-week, open-label, single arm sub investigation in subjects 8 to 12 years of age with amblyopia, in which selected sites could participate. Subjects received binocular videogame treatment for 8 weeks, followed by 8 weeks of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
DDO001, amblyopia, binocular video games, patching, eye disorder, lazy eye, unable to focus in one eye, eye muscle disorder, wandering eye, abnormal vision development

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Part A: Single-masked by outcome assessor only Part B: Open-label
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patching
Arm Type
Active Comparator
Arm Description
Patching of the sound eye (fellow eye) - patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks.
Arm Title
Binocular video games
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Binocular video games
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Patching of the sound eye
Intervention Description
Patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks.
Primary Outcome Measure Information:
Title
Change in best corrected visual acuity (BCVA) in the amblyopic eye.
Description
Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).
Time Frame
from Baseline to Week 8
Secondary Outcome Measure Information:
Title
Attain BCVA of 0.1 logMAR or better in the amblyopic eye
Description
Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).
Time Frame
at Week 4, Week 8, Week 12, and Week 16.
Title
Change in stereoacuity or binocular video game relative to patching.
Description
Part A: Stereoacuity will be assessed at near using Randot Preschool Stereoacuity Test (Stereo Optical, Inc.). The test is performed using 3 stereotest booklets while wearing 3D glasses. In short, in each test booklet, the left-hand page shows two-dimensional black-and-white silhouettes of two sets (panels) of four test shapes. The right-hand page contains two sets of four random-dot patterns in different sequences that are on the left-hand page. In each set of random-dot patterns, one contains no test shape, while the remaining contains test shapes. The child must correctly identify at least two of the three test shapes at each disparity level.
Time Frame
from Baseline to Week 4, Week 8, Week 12, and Week 16.
Title
Attain a 2-line or better improvement in BCVA in the amblyopic eye
Description
Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).
Time Frame
at Week 4, Week 8, Week 12, and Week 16.
Title
Change in BCVA in the amblyopic eye
Description
Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).
Time Frame
from Baseline to Week 4, Week 12, and Week 16.
Title
Frequency of treatment-emergent Adverse Events
Description
Part A and B: An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical study subject, user or other person, after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of the study device, i.e., videogame system (tablet, software, 3D glasses) or patch.
Time Frame
from Baseline to week 16
Title
Time played as recorded in the diary
Description
Part A: To assess compliance with treatment
Time Frame
from Baseline to week 12
Title
Time patched as recorded in the diary
Description
Part A: To assess compliance with treatment
Time Frame
from Baseline to week 16
Title
Time played as recorded in the video game system
Description
Parts A and B: To assess compliance with treatment
Time Frame
from Baseline to week 12
Title
Percentage of participants who complete at least 75% of prescribed game play
Description
Parts A and B: To assess compliance with treatment
Time Frame
from Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Novartis Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Novartis Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Novartis Investigative Site
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21703
Country
United States
Facility Name
Novartis Investigative Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
98102
Country
United States
Facility Name
Novartis Investigative Site
City
North Ryde
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Novartis Investigative Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2A 0K5
Country
Canada
Facility Name
Novartis Investigative Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L3G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18045
Description
Results for CDDO001F12201 from the Novartis Trials Website

Learn more about this trial

Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia

We'll reach out to this number within 24 hrs