Diabetic macular edema (DME)
Conditions
Interventions
Home-based care group:Home-based care monitoring with self-administered ETDRS visual acuity tester and self-administered OCT imaging
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Participant-level: Age of 18 years or older; 2.Participant-level: Type 1 or type 2 diabetes mellitus; 3.Participant-level: Current regular use of insulin for the treatment of diabetes or current regular use of oral anti-hyperglycemia agents for the treatment of diabetes; 4.Participant-level: Travel time from home to the hospital within a 2-hour driving distance; 5.Participant-level: Ability and willingness to operate the self-administrated visual acuity tester and Home OCT by themselves or with the help of family after training; 6.Participant-level: At least one eye meets the study eye criteria; 7.Participant-level: Ability and willingness to provide informed consent; 8.Study eye-level: Central-involved DME (CST on OCT defined on Heidelberg Spectralis OCT >= 320 µm in men and >= 305 µm in women or Zeiss Cirrus OCT >= 305 µm in men and >= 290 µm in women); 9.Study eye-level: Best corrected visual acuity letter score = 24 (i.e., 20/320 or better) within seven days of inclusion; 10.Study eye-level:Received no treatment for DME before or received no anti-VEGF injection within the past 3 months (however, if there is a history of anti-VEGF injections, <=1 injection in the past year and <=3 injections over the study participant's lifetime); or, <= 2 monthly injections within the past 3 months and <= 3 injections over the past year, and <= 6 injections over the study participant's lifetime; 11.Study eye-level: Sufficient media clarity, pupillary dilation, and individual cooperation to allow for adequate fundus photographs and adequate OCT;
Exclusion criteria
Exclusion criteria: 1.Participant-level: 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; 2.Participant-level: History of systemic anti-VEGF or pro-VEGF treatment within 4 months before randomization. These drugs should not be used during the study; 3.Participant-level: 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 individual may be eligible; 4.Participant-level: History of myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months before randomization; 5.Participant-level: For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 2 years. Women who are potential study participants should be questioned about the potential for pregnancy, and the investigator will determine when a pregnancy test is needed; 6.Participant-level: Currently participating in other clinical trials; 7.Participant-level: The individual who might move out to an area beyond 2-hour driving distance during the first 12 months of the study; 8.Study eye-level: Macular edema due to reasons other than diabetes; 9.Study eye-level: Any history of prior laser, other surgical or corticosteroid treatment for DME (such as focal/grid macular photocoagulation, intravitreal corticosteroids or peribulbar corticosteroids) within the prior 12 months; 10.Study eye-level: History of intravitreal anti-VEGF for an ocular condition other than DME (e.g., choroidal neovascularization, central retinal vein occlusion, PDR) within the prior 6 months or anticipated need in the next 6 months; 11.Study eye-level: Coexisting ocular diseases that might alter visual acuity during the course of the study, such as a retinal vein or artery occlusion, uveitis or other ocular inflammatory diseases, neovascular glaucoma, etc. 12.Study eye-level: A substantial cataract that, in the investigator’s opinion, is likely to be decreasing visual acuity by 3 lines or more. This means that the cataract would be reducing acuity to 20/40 or worse if the eye were otherwise normal; 13.Study eye-level: History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckling, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization; 14.Study eye-level: Uncontrolled glaucoma in the investigator’s judgment; 15.Study eye-level: Severe external ocular infection, including conjunctivitis, or substantial blepharitis;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in best-corrected visual acuity (letter score) at 96 weeks from the randomization visit; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean hospital/clinic visits with the home-based care group versus standard hospital/clinic-based care group;Other visual outcomes;OCT outcomes;Lapses in care;Ability to Work and Perform Regular Activities;Economic analysis (Cost-utility ratio);Visual acuity and OCT outcomes in the non-study eyes; | — |
Countries
China
Contacts
Public ContactYingfeng Zheng
Zhongshan Ophthalmic Center, Sun Yat-sen University
Outcome results
None listed