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Recruiting NCT07255859

NCT07255859 AVIGA3 (Cohort 2.0)

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Clinical Trial Summary
NCT ID NCT07255859
Status Recruiting
Phase —
Sponsor Tan Tock Seng Hospital
Condition Maculopathy
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2025-06-16
Primary Completion 2027-07-31

Eligibility & Interventions

Sex All sexes
Min Age 50 Years
Max Age 99 Years
Study Type INTERVENTIONAL
Interventions
Amsler GridAVIGA

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 60 participants in total. It began in 2025-06-16 with a primary completion date of 2027-07-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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. 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.

Eligibility Criteria

Inclusion criteria 1. Subjects in the age group ≥ 50 to 99 years old. 2. Both genders 3. Able to understand verbal spoken instructions in British/American English, Chinese or Bahasa Melayu and demonstrate device functionality and implementation. 4. Able to turn on and connect the web-camera to a computer independently or with the help of family. 5. 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. 6. Ability to comply with the study protocol, in the investigator's judgment. 7. Subjects must be able to understand and provide informed consent. A signed informed consent form must be provided before any study assessments. Exclusion criteria 1. Unable to understand verbal spoken instructions and demonstrate device functionality and implementation. 2. Unable to turn on and connect the web-camera to a computer independently. 3. Any ocular surgery in the previous 3 months, or vitrectomy in the previous 12 months 4. Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye 5. 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 6. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye. 7. History of idiopathic or autoimmune-associated uveitis in either eye 8. Active ocular inflammation or suspected or active ocular or periocular infection in either eye.

Contact & Investigator

Central Contact

Zheng Kuang, Noel Soh, BSc

✉ zheng.Kuang.soh@nhghealth.com.sg

📞 +65 6357 3693

Principal Investigator

Augustinus Laude, MBChB, MSc, FRCSEd (Ophth), FA

PRINCIPAL INVESTIGATOR

Tan Tock Seng Hospital

Frequently Asked Questions

Who can join the NCT07255859 clinical trial?

This trial is open to participants of all sexes, aged 50 Years or older, up to 99 Years, studying Maculopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07255859 currently recruiting?

Yes, NCT07255859 is actively recruiting participants. Contact the research team at zheng.Kuang.soh@nhghealth.com.sg for enrollment information.

Where is the NCT07255859 trial being conducted?

This trial is being conducted at Singapore, Singapore.

Who is sponsoring the NCT07255859 clinical trial?

NCT07255859 is sponsored by Tan Tock Seng Hospital. The principal investigator is Augustinus Laude, MBChB, MSc, FRCSEd (Ophth), FA at Tan Tock Seng Hospital. The trial plans to enroll 60 participants.

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