Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia

Stopped early · Phase 1

Conditions studied: Amblyopia

In brief

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.

Key facts

Study ID

NCT04784390

Run by

Novartis Pharmaceuticals

People needed

27

Starts

2021-06-30

Expected to finish

2022-08-03

Last updated by the study team

2023-05-23

Who can join

Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Novartis Investigative Site — Gainesville, Florida, United States
• Novartis Investigative Site — Maitland, Florida, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Frederick, Maryland, United States
• Novartis Investigative Site — Las Vegas, Nevada, United States
• Novartis Investigative Site — North Ryde, New South Wales, Australia
• Novartis Investigative Site — Kitchener, Ontario, Canada
• Novartis Investigative Site — Waterloo, Ontario, Canada

Full record on ClinicalTrials.gov

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