Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04784390
• Collaborator: (none)
• Enrollment: 95
• Locations: 16
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Amblyopia	Device: Binocular video games; Device: Patching of the sound eye	Phase 1

Detailed Description

The study consists 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Part A: Single-masked by outcome assessor only Part B: Open-label
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jun 30, 2021
• Anticipated Primary Completion Date: Nov 2, 2022
• Anticipated Study Completion Date: Jun 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patching 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.	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.
Experimental: Binocular video games 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: 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.

Outcome Measures

Primary Outcome Measures

1. Change in best corrected visual acuity (BCVA) in the amblyopic eye. [from Baseline to Week 8]

   Part A: To assess binocular video games relative to patching of the sound eye (fellow eye) based on change from baseline in the amblyopic eye BCVA.

Secondary Outcome Measures

1. Attain BCVA of 0.1 logMAR or better in the amblyopic eye [at Week 4, Week 8, Week 12, Week 16, Week 26, and Week 52]

   Part A: To evaluate the proportion of binocular video game-treated subjects achieving BCVA of 0.1 logMAR (20/25) or better in the amblyopic eye relative to patching

2. Change in stereoacuity or binocular video game relative to patching. [from Baseline to Week 4, Week 8, Week 12, Week16, Week 26 and Week 52]

   Part A: Change in stereoacuity, as measured by Randot Preschool Stereoacuity test, for binocular video games relative to patching

3. Attain a 2-line or better improvement in BCVA in the amblyopic eye [at Week 4, Week 8, Week 12, Week 16, Week 26, and Week 52]

   Part A: To evaluate the proportion of binocular video game-treated subjects achieving a 2-line or better improvement in the amblyopic eye relative to patching.

4. Change in BCVA in the amblyopic eye [from Baseline to Week 4, Week 12, Week16, Week 26 and Week 52]

   Part A: To evaluate the change in BCVA in the amblyopic eye for binocular video game relative to patching

5. Frequency of treatment-emergent Adverse Events [from Baseline to week 52]

   Part A and B: To assess safety and tolerability of the binocular video games, including Adverse device effects.

6. Time played as recorded in the diary [from Baseline to week 12]

   Part A: To assess compliance with treatment

7. Time patched as recorded in the diary [from Baseline to week 16]

   Part A: To assess compliance with treatment

8. Time played as recorded in the video game system [from Baseline to week 12]

   Parts A and B: To assess compliance with treatment

9. Percentage of participants who complete at least 75% of prescribed game play [from Baseline to Week 12]

   Parts A and B: To assess compliance with treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Los Angeles	California	United States	90095
2	Novartis Investigative Site	Santa Barbara	California	United States	93105
3	Novartis Investigative Site	Gainesville	Florida	United States	32605
4	Novartis Investigative Site	Maitland	Florida	United States	32751
5	Novartis Investigative Site	Chicago	Illinois	United States	60611
6	Novartis Investigative Site	Frederick	Maryland	United States	21703
7	Novartis Investigative Site	Boston	Massachusetts	United States	02115
8	Novartis Investigative Site	Saint Louis	Missouri	United States	63104
9	Novartis Investigative Site	Las Vegas	Nevada	United States	98102
10	Novartis Investigative Site	Columbus	Ohio	United States	43205
11	Novartis Investigative Site	Lancaster	Pennsylvania	United States	17601
12	Novartis Investigative Site	North Ryde	New South Wales	Australia	2109
13	Novartis Investigative Site	Sydney	New South Wales	Australia	2052
14	Novartis Investigative Site	Westmead		Australia	2145
15	Novartis Investigative Site	Kitchener	Ontario	Canada	N2A 0K5
16	Novartis Investigative Site	Waterloo	Ontario	Canada	N2L3G1

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04784390
• Other Study ID Numbers: CDDO001F12201
• First Posted: Mar 5, 2021
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Novartis Pharmaceuticals: DDO001; amblyopia; binocular video games; patching; eye disorder; lazy eye; unable to focus in one eye; eye muscle disorder; wandering eye; abnormal vision development
• Additional relevant MeSH terms: Amblyopia

Study Results

No Results Posted as of Aug 1, 2022