Summary

Eligibility
for people ages 4-12 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Amblyopia DDO001 binocular video games patching eye disorder lazy eye unable to focus in one eye eye muscle disorder wandering eye abnormal vision development Patching of the sound eye

Eligibility

You can join if…

Open to people ages 4-12

  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).

You CAN'T join if...

  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.

Locations

  • Novartis Investigative Site accepting new patients
    Los Angeles California 90095 United States
  • Novartis Investigative Site accepting new patients
    Santa Barbara California 93105 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT04784390
Phase
Phase 1 Amblyopia Research Study
Study Type
Interventional
Participants
Expecting 95 study participants
Last Updated