Status:
RECRUITING
Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborating Sponsors:
Dongguan Guangming Ophthalmic Hospital
The Second People's Hospital of Foshan
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pharmacolo...
Detailed Description
This visit and treatment burden is associated with poorer DME treatment outcomes in the clinical practice (real world) setting compared with outcomes in clinical trials. Studies have shown that less t...
Eligibility Criteria
Inclusion
- Participant-level 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
- 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 individual may be eligible
- 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 enrollment
- 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
- Currently participating in other clinical trials
- 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 Criteria:
- The participant must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below. Participants can have only one study eye. If both eyes are eligible at the time of enrollment and one of the eyes has never received anti-VEGF treatment, that eye should be included. If both eyes are eligible and have previously received anti-VEGF treatment or both eyes have never received anti-VEGF, then the better-seeing eye will be selected before enrollment. If neither eligible eye is the better-seeing eye, then the investigator and participant will select the study eye by mutual agreement before enrollment.The definition of better-seeing, worse-seeing and same eye is in the followings:
- If the baseline visual acuity letter score in both eyes is 50 (20/100) or better, the better-seeing eye is the eye with better baseline visual acuity (better than that of the fellow eye by 5 letters or more), and the worse-seeing eye is the eye with worse baseline visual acuity (worse than that of the fellow eye by 5 letters or more); if the baseline visual acuity of one eye is within 4 letters of that of the fellow eye, the two eyes are the same and neither eye is the better-seeing eye.
- If the baseline visual acuity letter score in both eyes is \< 50 (20/100), the better-seeing eye is the eye with better baseline visual acuity (better than that of the fellow eye by 10 letters or more), and the worse-seeing eye is the eye with worse baseline visual acuity (worse than that of the fellow eye by 10 letters or more); if the baseline visual acuity of study eye is within 9 letters of that of the fellow eye, the two eyes are the same and neither eye is the better-seeing eye.
- The eligibility criteria for a study eye are as follows:
- Inclusion Criteria:
- Central-involved DME (central subfield thickness on OCT defined on Heidelberg Spectralis OCT 320 μm or more in men and 305 μm or more in women, or Zeiss Cirrus OCT 305 μm or more in men and 290 μm or more in women, or the equivalent on spectral-domain OCT based on gender specific cutoffs)
- Best corrected visual acuity letter score ≤ 78 (i.e., 20/32 or worse) and ≥ 24 (i.e., 20/320 or better) within seven days of inclusion
- Received no treatment for DME before, or received no anti-VEGF injection for DME 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.
- Sufficient media clarity, pupillary dilation, and individual cooperation to allow for adequate fundus photographs and adequate OCT
Key Trial Info
Start Date :
October 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT06610747
Start Date
October 28 2024
End Date
April 30 2027
Last Update
January 22 2025
Active Locations (3)
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1
Dongguan Guangming Ophthalmic Hospital
Dongguan, Guangdong, China
2
The Second Peoples Hospital of Foshan
Foshan, Guangdong, China
3
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000