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Compares treatment options for Diabetic Macular Edema
Official title Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT
ClinicalTrials.gov ID: NCT06610747
What this study is testing
What is Aflibercept 2Mg/0.05Ml Inj,Oph?
Aflibercept 2Mg/0.05Ml Inj,Oph is an investigational medicine, given as a monthly treatment applied to the skin, being studied as a potential treatment for diabetic macular edema.
Also referred to as Aflibercept 2-mg/0.05mL intravitreal ophthalmic injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 96 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant-level Criteria: To be eligible, the following 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
You likely can't join if
- 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...
- 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...
- Blood pressure \> 180/110 (systolic above 180 or diastolic above 110. If blood pressure is brought below 180/110 by anti-hypertensive treatment, then...
- History of myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute...
See the full eligibility criteria
- Participant-level Criteria: To be eligible, the following 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Sufficient media clarity, pupillary dilation, and individual cooperation to allow for adequate fundus photographs and adequate OCT Exclusion Criteria: The following exclusions apply to the study eye only (i.e., they may...
- Macular edema due to reasons other than diabetes
- 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
- 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
- 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.
- 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...
- 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
- Uncontrolled glaucoma
- Severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.
The study team makes the final eligibility decision.
Where it's taking place
- Dongguan, Guangdong, China
- Foshan, Guangdong, China
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 96 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dongguan, Guangdong, China; Foshan, Guangdong, China; Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.