AmblyopiaPhase 1NCT04784390
Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia
A Phase 1 study testing Binocular video games and Patching of the sound eye in people with Amblyopia, run by Novartis Pharmaceuticals at 8 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Binocular video games and Patching of the sound eye
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 30 Jun 2021to 3 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States5 sites
Novartis Investigative Site
Chicago, Illinois, 60611
Novartis Investigative Site
Frederick, Maryland, 21703
Novartis Investigative Site
Gainesville, Florida, 32605
Novartis Investigative Site
Las Vegas, Nevada, 98102
Novartis Investigative Site
Maitland, Florida, 32751
Canada2 sites
Novartis Investigative Site
Kitchener, Ontario, N2A 0K5
Novartis Investigative Site
Waterloo, Ontario, N2L3G1
Australia1 site
Novartis Investigative Site
North Ryde, New South Wales, 2109
About this study
Official title: A 16 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
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.
Read the 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-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.
- Conditions
- Amblyopia
- Being tested
- Binocular video games, Patching of the sound eye
- Keywords
- DDO001, amblyopia, binocular video games, patching, eye disorder, lazy eye, unable to focus in one eye, eye muscle disorder, wandering eye, abnormal vision development
- Medical subject headings
- Amblyopia, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binocular video gamesDevice
Patients will play 1 hour of binocular video game of choice (Dig Rush and/or Monster Burner) a day 7 days a week for 8 to 12 weeks.
Patching of the sound eyeDevice
Patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patching | Active comparator | Patching of the sound eye (fellow eye) - patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks. Receives: Device: Patching of the sound eye |
| Binocular video games | Experimental | Binocular video games - patients will play 1 hour of binocular video game of choice (Dig Rush and/or Monster Burner) a day 7 days a week for 8 to 12 weeks. Receives: Device: Binocular video games |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: from Baseline to Week 8
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: from Baseline to week 16
Time played as recorded in the diary
Part A: To assess compliance with treatment
Measured: from Baseline to week 12
Time patched as recorded in the diary
Part A: To assess compliance with treatment
Measured: from Baseline to week 16
Time played as recorded in the video game system
Parts A and B: To assess compliance with treatment
Measured: 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
Measured: from Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start30 Jun 2021
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Why it stopped: The study was terminated based upon the competitive landscape and strategic fit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784390
- Sponsor's protocol ID
- CDDO001F12201
- Status last verified
- May 2023
- First submitted
- 2 Mar 2021
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16 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
- ClinicalTrials.gov ID
- NCT04784390
- Acronym / sponsor ID
- CDDO001F12201
- Conditions
- Amblyopia
- Keywords
- DDO001, amblyopia, binocular video games, patching, eye disorder, lazy eye, unable to focus in one eye, eye muscle disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated based upon the competitive landscape and strategic fit.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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-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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patching | Active comparator | Device: Patching of the sound eyePatching of the sound eye (fellow eye) - patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks. |
| Binocular video games | Experimental | Device: Binocular video gamesBinocular video games - patients will play 1 hour of binocular video game of choice (Dig Rush and/or Monster Burner) a day 7 days a week for 8 to 12 weeks. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binocular video gamesPatients will play 1 hour of binocular video game of choice (Dig Rush and/or Monster Burner) a day 7 days a week for 8 to 12 weeks. | Device | Binocular video games |
| Patching of the sound eyePatients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks. | Device | Patching |
Primary outcome
Change in best corrected visual acuity (BCVA) in the amblyopic eye.
Time frame: from Baseline to Week 8
Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).
9 secondary outcomes
Attain BCVA of 0.1 logMAR or better in the amblyopic eye
Time frame: at Week 4, Week 8, Week 12, and Week 16.
Change in stereoacuity or binocular video game relative to patching.
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
Time frame: at Week 4, Week 8, Week 12, and Week 16.
Change in BCVA in the amblyopic eye
Time frame: from Baseline to Week 4, Week 12, and Week 16.
Frequency of treatment-emergent Adverse Events
Time frame: from Baseline to week 16
Time played as recorded in the diary
Time frame: from Baseline to week 12
Time patched as recorded in the diary
Time frame: from Baseline to week 16
Time played as recorded in the video game system
Time frame: from Baseline to week 12
Percentage of participants who complete at least 75% of prescribed game play
Time frame: from Baseline to Week 12
Results and safety
The study was stopped early (reason given: The study was terminated based upon the competitive landscape and strategic fit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Results for CDDO001F12201 from the Novartis Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Binocular video games and Patching of the sound eye in people with Amblyopia, run by Novartis Pharmaceuticals at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated based upon the competitive landscape and strategic fit.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in best corrected visual acuity (BCVA) in the amblyopic eye. (time frame: from Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.