TerminatedPhase 1

Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia

Stopped: The study was terminated based upon the competitive landscape and strategic fit.

United States27 participantsStarted 2021-06-30

Plain-language 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.

Who can participate

Age range4 Years – 12 Years

SexALL

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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

What they're measuring

Change in best corrected visual acuity (BCVA) in the amblyopic eye.

Timeframe: from Baseline to Week 8

Trial details

NCT IDNCT04784390

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-03

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