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

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study ID
NCT06610747
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Home-based Care Monitoring — PROCEDURE
    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
    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
    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.

Study Details

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.

Key Dates

Start date
Oct 28, 2024
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
308 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Home-based care group
    Home-based monitoring with home visual acuity tester and home OCT: 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.
  • Active Comparator: Standard Hospital/clinic-based care group
    Standard hospital/clinic-based visual acuity and OCT 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.

Primary Outcome Measure

Change in best-corrected visual acuity (letter score) in the study eyes from the randomization visit to 96 week visit [ Time Frame: From the randomization visit to 96 week visit ]

Central Contacts

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