Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT (NCT06610747) | Clinical Trial Compass
RecruitingNot Applicable
Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT
China308 participantsStarted 2024-10-28
Plain-language summary
Diabetic macular edema (DME) is a common cause of central visual loss in diabetic patients and a global public health burden around the world. Most patients with DME and vision loss require pharmacological inhibition using anti-VEGF agents with multiple monitoring visits that require both visual acuity testing and optical coherence tomography (OCT) to determine if re-treatment is warranted as well as the recommended time interval to the next follow-up visit. However, this treatment regimen often requires monthly or every other month clinic visits, which places a substantial burden on ophthalmic clinics and patients.
Recently, portable self-administered Home OCT devices have been developed that allow for home-based OCT scanning of retinal diseases, e.g., DME, although these devices do not include visual acuity determination. The investigators previously proposed to deliver Home OCT devices and Home visual acuity tester to patients\' homes to complete routine monitoring visits at home. However, there is a lack of evidence regarding the safety and efficacy of this novel monitoring regimen for DME patients, specifically whether its use could reduce the burden associated with frequent hospital visits without sacrificing visual acuity outcomes.
This study aims to provide evidence to support use of a novel monitoring regimen for DME patients that could substantially reduce the burden associated with frequent hospital visits without sacrificing visual acuity outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Participant-level Criteria:
Inclusion Criteria:
To be eligible, the following inclusion criteria must be met:
* Age of 18 years or older;
* Type 1 or type 2 diabetes mellitus
* Current regular use of insulin for the treatment of diabetes or current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
* Travel time from home to the hospital/clinic within a 2-hour driving distance
* At least one eye meets the study eye criteria listed in Section 2.4
* Ability and willingness to operate the self-administrated visual acuity tester and Home OCT device by themselves or with the help of family after training
* Ability and willingness to provide informed consent
Exclusion Criteria:
An individual is not eligible if any of the following exclusion criteria are present:
* Conditions that would preclude participation in the study, such as unstable medical status including blood pressure, cardiovascular disease, renal disease, and glycemic control as determined by the investigators
* History of systemic anti-VEGF or pro-VEGF treatment within 4 months before randomization. These drugs should not be used during the study;
* In an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied
* Blood pressure \> 180/110 (systolic above 180 or diastolic above 110. If blood pressure is brought below 180/110 by anti-hypertensive treatment, then the individua…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in best-corrected visual acuity (letter score) in the study eyes from the randomization visit to 96 week visit
Timeframe: From the randomization visit to 96 week visit
Trial details
NCT IDNCT06610747
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University