NCT06610747

Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT

Home Care Monitoring of Visual Acuity and OCT Versus Standard Hospital/Clinic Care Monitoring During Diabetic Macular Edema Management: A Non-inferiority Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 than half of DME patients remain compliant with their anti-VEGF treatment schedules in the clinical practice setting, with many experiencing worse visual acuity levels after missed appointments. Potential reasons for suboptimal outcomes include under-treatment when otherwise indicated, missed visits when treatment should be applied, absence of protocol refractions and protocol visual acuity measurements which may guide treatment but be difficult to obtain in clinic, and anti-VEGF costs. Addressing these challenges could benefit from a novel approach of monitoring patients remotely so that visits only would be needed when treatment was warranted based on changes in best corrected visual acuity or OCT central subfield thickness measurements, but only if this approach does not sacrifice visual acuity outcomes. In particular, reducing the frequency of clinic visits might improve patient compliance and potentially improve treatment outcomes. To address these challenges, new devices, which currently are not readily available around the world, and new agents or anti-VEGF delivery devices have been developed to try to reduce the burden of injections without sacrificing visual acuity outcomes. However, most of these new agents that could be given q8 or q12 or q16 weeks in some study participants provided non-inferior visual acuity outcomes only in the setting of protocols that included q4week clinic assessments. Potentially, this frequent monitoring may be needed to avoid sacrificing visual acuity outcomes when reducing the number of injections. Furthermore, new delivery devices have been fraught with safety concerns. Recently, portable self-administered Home OCT devices have been developed that allow for home-based OCT scanning of retinal diseases, e.g., DME, nAMD, or CNV associated with pathologic myopia. The image quality and accuracy of retinal thickness measurements obtained from some of these devices have been validated through comparison with clinic- or hospital-based OCTs, although evaluation of these devices has not included home monitoring of visual acuity, nor determined if their use results in non-inferior visual acuity outcomes. In this study, the investigators will conduct a non-inferiority randomized clinical trial to determine if the mean change in visual acuity (primary outcome) is non-inferior with the home monitoring of visual acuity and OCT compared with hospital/clinic-based care among DME participants receiving anti-VEGF therapy, and if it is non-inferior, to determine if the home care model can reduce hospital/clinic visits over 96 weeks (principal secondary outcome). Participants will receive five q4week loading anti-VEGF injections after enrollment. Only those participants who receive loading injections as planned will be assigned randomly to one of two groups and undergo as needed (pro-re-nata, PRN) treatments with injections of anti-VEGF: 1. Home-based Care Group 2. Standard Hospital/clinic-based Care Group Re-injections of anti-VEGF (PRN), laser, surgery or other procedures will be performed per protocol for participants from both groups.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
PROCEDURE	Home-based Care Monitoring	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.
DRUG	Aflibercept 2Mg/0.05Ml Inj,Oph	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.
PROCEDURE	Laser Treatment	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.
PROCEDURE	Standard Hospital/clinic-based Care Monitoring	For participants in the standard Hospital/clinic-based group, hospital service appointments will be scheduled during the \'pro re nada\' (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.

Timeline

• Start date: 2024-10-28
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2024-09-24
• Last updated: 2025-01-22

Locations

3 sites across 1 country: China