MaculopathyAVIGA3NCT07255859
AVIGA3 (Cohort 2.0)
A study testing Amsler Grid and AVIGA in people with Maculopathy, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
Age-Macular Degeneration (AMD) is a common eye condition and a leading cause of vision loss among people age 50 and older. It causes damage to the macula, a small area near the centre of the retina needed for sharp, central vision. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Maculopathy
- What is being tested?
- Amsler Grid and AVIGA
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 16 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects in the age group ≥ 50 to 99 years old.
- Both genders
- Able to understand verbal spoken instructions in British/American English, Chinese or Bahasa Melayu and demonstrate device functionality and implementation.
- Able to turn on and connect the web-camera to a computer independently or with the help of family.
- Subjects undergoing treatment for Wet-AMD without any signs and symptoms of recurrence of active AMD (AMD recurrence: choroidal neovascularisation, intraretinal or subretinal fluid is present) with OCT lesion fluid volume more than 2 mm3 or ILM height more than 250µm.
- Ability to comply with the study protocol, in the investigator's judgment.
- Subjects must be able to understand and provide informed consent. A signed informed consent form must be provided before any study assessments.
Who cannot join
- Unable to understand verbal spoken instructions and demonstrate device functionality and implementation.
- Unable to turn on and connect the web-camera to a computer independently.
- Any ocular surgery in the previous 3 months, or vitrectomy in the previous 12 months
- Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
- Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
- Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye.
- History of idiopathic or autoimmune-associated uveitis in either eye
- Active ocular inflammation or suspected or active ocular or periocular infection in either eye.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Zheng Kuang Noel Soh, BSc, +65 6357 3693, zheng.Kuang.soh@nhghealth.com.sg
Augustinus Laude, MBChB
About this study
Official title: AVIGA3: Using an 'Automated Vision Assessment and Impairment Detection Through Gaze Analysis' Through a Longitudinal, Open-labelled, Randomized Clinical Trial to Monitor Recurrence of Aged-related Macular Degeneration in a Home-based Setting (Cohort 2.0).
Age-Macular Degeneration (AMD) is a common eye condition and a leading cause of vision loss among people age 50 and older. It causes damage to the macula, a small area near the centre of the retina needed for sharp, central vision. It is estimated that the prevalence of early and late AMD in Asian populations aged 40 to 79 were 6.8% and 0.56% respectively. Prevalence in white populations estimated from large population studies were 8.8% and 0.59% respectively. With the aging population and people living longer, these numbers will only increase. Hence, this study aims to develop a system to evaluate the AVIGA system through remote monitoring for disease recurrence of wet aged-related macular degeneration using eye gaze tracking.
Read the detailed description
Age-Related Macular Degeneration (AMD) is one of the main causes of central vision loss. Most patients require pharmacologic treatment with anti-vascular endothelial growth factor (VEGF) agents with multiple follow-up visits that include optical coherence tomography (OCT), visual acuity testing and multiple injections.
The high frequency of visits puts pressure on eye clinics and can be extremely stressful for both patients and their caregivers. Therefore, portable and rapidly deployable self-administered home-based examination devices are key to making telemedicine a reality.
The study team has developed a portable, self-administered online based assessment, designed for gaze-tracking and monitoring of patients with retinal diseases such as AMD, and choroidal neovascularization (CNV) that require multiple anti-VEGF injections.
The team have confirmed the performance of the AVIGA system and validated the retinal thickness measurements obtained with this device by comparing it to in-hospital Optical Coherence Tomography (OCT) (Heidelberg Spectralis). In this study, the team will conduct an open-labelled, randomized clinical trial (RCT) to compare the efficacy and cost-effectiveness of a Pro Re Nana (PRN) management regimen enhanced with the AVIGA home-monitoring platform for the detection of central metamorphopsia with existing PRN standard of care for patients with AMD exiting the anti-VEGF injection regimen.
- Conditions
- Maculopathy
- Being tested
- Amsler Grid, AVIGA
- Keywords
- aged-related macular degeneration, choroidal neovascularization, wet aged-related macular degeneration, gaze tracking, dry aged-related macular degeneration, maculopathy
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amsler GridDiagnostic test
The Amsler grid is a tool used to monitor the macula, the central part of the retina, for changes in vision that can be indicative of various eye conditions, particularly age-related macular degeneration (AMD). It helps detect and monitor metamorphopsia (distorted vision) or scotoma (blind spots) in the central visual field.
AVIGADevice
The AVIGA system tracks these eye movements with generated patterns on the screen, a visual assessment of affected and unaffected eyes is achieved at home on any tablet or laptop computer.
AVIGA is a home-based gaze-tracking system for hyperacuity monitoring of high-risk eyes with diagnosed wet-AMD.
| Study group | Role | What they receive |
|---|---|---|
| Amsler Grid | Active comparator | The Amsler grid is a tool used to monitor the macula, the central part of the retina, for changes in vision that can be indicative of various eye conditions, particularly age-related macular degeneration (AMD). It helps detect and monitor metamorphopsia (distorted vision) or scotoma (blind spots) in the central visual field. Receives: Diagnostic Test: Amsler Grid |
| AVIGA Arm | Experimental | The AVIGA system tracks eye movements following generated patterns projected on the screen. Assessment of affected and unaffected eyes can be achieved at home using any computer screen.
AVIGA is a home-based gaze-tracking system for monitoring of high-risk eyes with wet-AMD. Receives: Device: AVIGA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy Using One-Sided Confidence Interval or One-Sided Hypothesis Test
To assess whether the AVIGA device is non-inferior to the standard of care (Amsler grid) in detecting recurrence of wet-AMD during patient recall, by comparing both generated scores, validated by OCT readings.
Measured: 12 Months
Secondary outcomes (2)
Correlation with Optical Coherence Tomography (OCT)
To determine the correlation between AVIGA gaze scores and average OCT height readings
Measured: 12 Months
User Experience & Functionality
Qualitative assessment of usability and patient adherence to the home testing protocol will be conducted by evaluating completion rates of AVIGA testing twice weekly. Consistent compliance will be interpreted as an indicator of protocol feasibility and user-friendliness, suggesting that the testing procedure was sufficiently accessible and manageable for patients to maintain regular adherence.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start16 Jun 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MaculopathyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laude Augustinus, Tan Tock Seng Hospital
- Investigators
- Augustinus Laude, MBChB, MSc, FRCSEd (Ophth), FA, Principal investigator, Tan Tock Seng HospitalZheng Kuang Noel Soh, BSc, Study director, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255859
- Sponsor's protocol ID
- 2024-3705
- Acronym
- AVIGA3
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVIGA3: Using an 'Automated Vision Assessment and Impairment Detection Through Gaze Analysis' Through a Longitudinal, Open-labelled, Randomized Clinical Trial to Monitor Recurrence of Aged-related Macular Degeneration in a Home-based Setting (Cohort 2.0).
- ClinicalTrials.gov ID
- NCT07255859
- Acronym / sponsor ID
- AVIGA3 / 2024-3705
- Conditions
- Maculopathy
- Keywords
- aged-related macular degeneration, choroidal neovascularization, wet aged-related macular degeneration, gaze tracking, dry aged-related macular degeneration, maculopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Dec 2025 (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.
Age-Macular Degeneration (AMD) is a common eye condition and a leading cause of vision loss among people age 50 and older. It causes damage to the macula, a small area near the centre of the retina needed for sharp, central vision. It is estimated that the prevalence of early and late AMD in Asian populations aged 40 to 79 were 6.8% and 0.56% respectively. Prevalence in white populations estimated from large population studies were 8.8% and 0.59% respectively. With the aging population and people living longer, these numbers will only increase. Hence, this study aims to develop a system to evaluate the AVIGA system through remote monitoring for disease recurrence of wet aged-related macular degeneration using eye gaze tracking.
Detailed description
Age-Related Macular Degeneration (AMD) is one of the main causes of central vision loss. Most patients require pharmacologic treatment with anti-vascular endothelial growth factor (VEGF) agents with multiple follow-up visits that include optical coherence tomography (OCT), visual acuity testing and multiple injections.
The high frequency of visits puts pressure on eye clinics and can be extremely stressful for both patients and their caregivers. Therefore, portable and rapidly deployable self-administered home-based examination devices are key to making telemedicine a reality.
The study team has developed a portable, self-administered online based assessment, designed for gaze-tracking and monitoring of patients with retinal diseases such as AMD, and choroidal neovascularization (CNV) that require multiple anti-VEGF injections.
The team have confirmed the performance of the AVIGA system and validated the retinal thickness measurements obtained with this device by comparing it to in-hospital Optical Coherence Tomography (OCT) (Heidelberg Spectralis). In this study, the team will conduct an open-labelled, randomized clinical trial (RCT) to compare the efficacy and cost-effectiveness of a Pro Re Nana (PRN) management regimen enhanced with the AVIGA home-monitoring platform for the detection of central metamorphopsia with existing PRN standard of care for patients with AMD exiting the anti-VEGF injection regimen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amsler Grid | Active comparator | Diagnostic Test: Amsler GridThe Amsler grid is a tool used to monitor the macula, the central part of the retina, for changes in vision that can be indicative of various eye conditions, particularly age-related macular degeneration (AMD). It helps detect and monitor metamorphopsia (distorted vision) or scotoma (blind spots) in the central visual field. |
| AVIGA Arm | Experimental | Device: AVIGAThe AVIGA system tracks eye movements following generated patterns projected on the screen. Assessment of affected and unaffected eyes can be achieved at home using any computer screen. AVIGA is a home-based gaze-tracking system for monitoring of high-risk eyes with wet-AMD. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects in the age group ≥ 50 to 99 years old.
- Both genders
- Able to understand verbal spoken instructions in British/American English, Chinese or Bahasa Melayu and demonstrate device functionality and implementation.
- Able to turn on and connect the web-camera to a computer independently or with the help of family.
- Subjects undergoing treatment for Wet-AMD without any signs and symptoms of recurrence of active AMD (AMD recurrence: choroidal neovascularisation, intraretinal or subretinal fluid is present) with OCT lesion fluid volume more than 2 mm3 or ILM height more than 250µm.
Key exclusion criteria (8 listed)
- Unable to understand verbal spoken instructions and demonstrate device functionality and implementation.
- Unable to turn on and connect the web-camera to a computer independently.
- Any ocular surgery in the previous 3 months, or vitrectomy in the previous 12 months
- Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
- Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
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 |
|---|---|---|
| Amsler GridThe Amsler grid is a tool used to monitor the macula, the central part of the retina, for changes in vision that can be indicative of various eye conditions, particularly age-related macular degeneration (AMD). It helps detect and monitor metamorphopsia (distorted vision) or scotoma (blind spots) in the central visual field. | Diagnostic test | Amsler Grid |
| AVIGAThe AVIGA system tracks these eye movements with generated patterns on the screen, a visual assessment of affected and unaffected eyes is achieved at home on any tablet or laptop computer. AVIGA is a home-based gaze-tracking system for hyperacuity monitoring of high-risk eyes with diagnosed wet-AMD. | Device | AVIGA Arm |
Primary outcome
Diagnostic Accuracy Using One-Sided Confidence Interval or One-Sided Hypothesis Test
Time frame: 12 Months
To assess whether the AVIGA device is non-inferior to the standard of care (Amsler grid) in detecting recurrence of wet-AMD during patient recall, by comparing both generated scores, validated by OCT readings.
2 secondary outcomes
Correlation with Optical Coherence Tomography (OCT)
Time frame: 12 Months
User Experience & Functionality
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Maculopathy
Active, not recruitingPhase 4
A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age-related Macular Degeneration (nAMD)
Active, not recruitingObservational study
A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy
Geographic Atrophy, Macular Degeneration
RecruitingPhase 3
Extension Study for the Port Delivery System With Ranibizumab (Portal)
Neovascular Age-Related Macular Degeneration
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
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.
Augustinus Laude, MBChB, MSc, FRCSEd (Ophth), FA principal investigator
Tan Tock Seng Hospital
Zheng Kuang Noel Soh, BSc study director
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amsler Grid and AVIGA in people with Maculopathy, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 8 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Kuang, Noel Soh, BSc (+65 6357 3693, zheng.Kuang.soh@nhghealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy Using One-Sided Confidence Interval or One-Sided Hypothesis Test (time frame: 12 Months). 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 24 Jun 2026.