Status:
TERMINATED
Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Amblyopia
Eligibility:
All Genders
4-12 years
Phase:
PHASE1
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 amb...
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-investigatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04784390
Start Date
June 30 2021
End Date
August 3 2022
Last Update
May 23 2023
Active Locations (8)
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1
Novartis Investigative Site
Gainesville, Florida, United States, 32605
2
Novartis Investigative Site
Maitland, Florida, United States, 32751
3
Novartis Investigative Site
Chicago, Illinois, United States, 60611
4
Novartis Investigative Site
Frederick, Maryland, United States, 21703