About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 &gt; 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

Trial design

Design model

Parallel

Treatments tested in this trial

Home-based Care Monitoring
Procedure/Surgery
For participants in the home-based care group, home service appointments will be scheduled during the 'pro re nada' (PRN) treatment phase. Participants will receive a home self-administered visual acuity tester and a self-administered Home OCT to use at home every 4 weeks after the 5th injection through 48 weeks, and then as needed per the DME treatment regimen protocol provided in the protocol. The results of the visual acuity and OCT measurements will be transmitted to the clinician at the hospital. An online discussion between the clinician and the participant will be held. Reports will be sent to the participant after each visit. In the event that the study coordinator is unable to contact the participant, a total of three phone call attempts will be made. Any failure to keep an appointment will be communicated to the participant.
Aflibercept 2Mg/0.05Ml Inj,Oph
Drug
Each eye will receive three to five q4week loading anti-VEGF injections of aflibercept (2-mg, EYLEA®) after enrollment to complete the initial loading phase of 5 doses. Each eye will then be treated according to the PRN treatment protocol described in the study protocol.
Laser Treatment
Procedure/Surgery
Panretinal photocoagulation (PRP) may be administered if deemed necessary by the investigator, typically for high-risk proliferative diabetic retinopathy (PDR). However, individuals are not eligible for this study if it is expected that they will require PRP within 6 months at the time of enrollment. In general, PRP should not be given to study participants with less than high risk PDR. For previously untreated eyes exhibiting PDR with high-risk characteristics, PRP should be administered promptly, while it can be considered, although generally not recommended, for persons with non-high-risk PDR or severe non-PDR who are being monitored monthly in this protocol. Focal/grid laser typically should be withheld until sometime after the final visit.
Standard Hospital/clinic-based Care Monitoring
Procedure/Surgery
For participants in the standard Hospital/clinic-based group, hospital service appointments will be scheduled during the \&amp;amp;#39;pro re nada\&amp;amp;#39; (PRN) treatment phase. Participants will be instructed to return to the clinic for hospital-based visual acuity examinations and standard OCT measurements every 4 weeks after the 5th injection through 48 weeks, and then as needed per the DME treatment regimen protocol provided in the protocol. A discussion between the clinician and the participant will be held in clinic. Reports will be sent to the participant after each visit. In the event that the study coordinator is unable to contact the participant, a total of three phone call attempts will be made. Any failure to keep an appointment will be communicated to the participant.

Treatment groups

308 Participants

are divided into 2 treatment groups

Group A: Home-based care groupExperimental treatment 3 interventions

Group B: Standard Hospital/clinic-based care groupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change in best-corrected visual acuity (letter score) in the study eyes from the randomization visit to 96 week visit

The randomization visit is defined as the visit of the 5th loading dose. Best-corrected visual acuity (letter score) will be measured by masked optometrists using the ETDRS tumbling-E eye chart. The testing procedures are detailed in the study protocol.

Time frame

From the randomization visit to 96 week visit

Secondary outcomes

1

Hospital/clinic visits with the home-based care group versus standard hospital/clinic-based care group

Hospital/clinic visits for DME or DR is the principal secondary outcome.

Time frame