Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia

NCT04784390 | Terminated Phase 1 FDA Device

• 1 other identifier: CDDO001F12201
• Study Type: interventional
• Target: 27
• Locations: 3 countries
• Sites: 8

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  from Baseline to Week 8

Secondary Outcomes (9)

• Attain BCVA of 0.1 logMAR or better in the amblyopic eye

  at Week 4, Week 8, Week 12, and Week 16.

• Change in stereoacuity or binocular video game relative to patching.

  from Baseline to Week 4, Week 8, Week 12, and Week 16.

• Attain a 2-line or better improvement in BCVA in the amblyopic eye

  at Week 4, Week 8, Week 12, and Week 16.

• Change in BCVA in the amblyopic eye

  from Baseline to Week 4, Week 12, and Week 16.

• Frequency of treatment-emergent Adverse Events

  from Baseline to week 16

Study Arms (2)

Patching

ACTIVE COMPARATOR

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

Binocular video games

EXPERIMENTAL

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

Interventions

Binocular video games DEVICE

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.

Binocular video games

Patching of the sound eye DEVICE

Patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks.

Patching

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Gainesville, Florida, 32605, United States

Location

Novartis Investigative Site

Maitland, Florida, 32751, United States

Location

Novartis Investigative Site

Chicago, Illinois, 60611, United States

Location

Novartis Investigative Site

Frederick, Maryland, 21703, United States

Location

Novartis Investigative Site

Las Vegas, Nevada, 98102, United States

Location

Novartis Investigative Site

North Ryde, New South Wales, 2109, Australia

Location

Novartis Investigative Site

Kitchener, Ontario, N2A 0K5, Canada

Location

Novartis Investigative Site

Waterloo, Ontario, N2L3G1, Canada

Location

Related Links

• Results for CDDO001F12201 from the Novartis Trials Website

MeSH Terms

Conditions

Amblyopia; Eye Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Part A: Single-masked by outcome assessor only Part B: Open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: June 30, 2021
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CA (2); US (5)