Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia

Phase 1TerminatedNCT04784390

Novartis Pharmaceuticals27 enrolled

Overview

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.

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-investigation in subjects 8 to 12 years of age. Part A was a 16-week, prospective, randomized, single-masked, multicenter, controlled, 2 arm, parallel-group clinical investigation in subjects 4 to 7 years of age with amblyopia. Subjects were randomly assigned in a 1:1 ratio to either binocular videogame treatment for 8 to 12 weeks or patching treatment for 16 weeks. Randomization was stratified by severity of amblyopia in eligible subjects (moderate amblyopia with best-corrected visual acuity (BCVA) of the amblyopic eye of 20/100 or better, or severe amblyopia with BCVA of the amblyopic eye worse than 20/100). Part B was a 16-week, open-label, single arm sub investigation in subjects 8 to 12 years of age with amblyopia, in which selected sites could participate. Subjects received binocular videogame treatment for 8 weeks, followed by 8 weeks of follow-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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). Exclusion Criteria: 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 (8)

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

Outcomes

Primary Outcomes

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).

Time frame: from Baseline to Week 8

Secondary Outcomes

Attain BCVA of 0.1 logMAR or better in the amblyopic eye

Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).

Time frame: at Week 4, Week 8, Week 12, and Week 16.

Change in stereoacuity or binocular video game relative to patching.

Part A: Stereoacuity will be assessed at near using Randot Preschool Stereoacuity Test (Stereo Optical, Inc.). The test is performed using 3 stereotest booklets while wearing 3D glasses. In short, in each test booklet, the left-hand page shows two-dimensional black-and-white silhouettes of two sets (panels) of four test shapes. The right-hand page contains two sets of four random-dot patterns in different sequences that are on the left-hand page. In each set of random-dot patterns, one contains no test shape, while the remaining contains test shapes. The child must correctly identify at least two of the three test shapes at each disparity level.

Time frame: 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

Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).

Time frame: at Week 4, Week 8, Week 12, and Week 16.

Change in 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).

Time frame: from Baseline to Week 4, Week 12, and Week 16.

Frequency of treatment-emergent Adverse Events

Part A and B: An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical study subject, user or other person, after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of the study device, i.e., videogame system (tablet, software, 3D glasses) or patch.

Time frame: from Baseline to week 16

Time played as recorded in the diary

Part A: To assess compliance with treatment

Time frame: from Baseline to week 12

Time patched as recorded in the diary

Part A: To assess compliance with treatment

Time frame: from Baseline to week 16

Time played as recorded in the video game system

Parts A and B: To assess compliance with treatment

Time frame: from Baseline to week 12

Percentage of participants who complete at least 75% of prescribed game play

Parts A and B: To assess compliance with treatment

Time frame: from Baseline to Week 12

Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia

Overview

Conditions

Interventions

Eligibility

Locations (8)

Outcomes

Primary Outcomes

Secondary Outcomes