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
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participant-level: 1. Age of 18 years or older; 2. Type 1 or type 2 diabetes mellitus; 3. 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. Travel time from home to the hospital within a 2-hour driving distance; 5. 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. At least one eye meets the study eye criteria; 7. Ability and willingness to provide informed consent; Study eye-level: 8.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. Best corrected visual acuity letter score = 24 (i.e., 20/320 or better) within seven days of inclusion; 10. 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. Su fficient media clarity, pupillary dilation, and individual cooperation to allow for adequate fundus photographs and adequate OCT;
Exclusion criteria
Exclusion criteria: Participant-level: 1. 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. History of systemic anti-VEGF or pro-VEGF treatment within 4 months before randomization. These drugs should not be used during the study; 3. 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. 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. 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. Currently participating in other clinical trials; 7. The individual who might move out to an area beyond 2-hour driving distance during the first 12 months of the study; Study eye-level: 8. Macular edema due to reasons other than diabetes; 9. 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. 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. Coexisting ocular diseases that might alter visual acuity during the course of the study, such as a retinal vein or artery occlusion, u veitis or other ocular inflammatory diseases, neovascular glaucoma, etc. 12. 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. 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. Uncontrolled glaucoma in the investigator’s judgment; 15. Severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis; 16.Participant-level: 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;
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;Long lapses in care;Mean changes in visual acuity and OCT outcomes in the non-study eyes;Economic analysis (Cost-utility ratio);Other visual outcomes;OCT outcomes;Ability to Work and Perform Regular Activities; | — |
Countries
China
Contacts
Public ContactZitian Liu
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed