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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Procedure: Home-based Care Monitoring; Procedure: Laser Treatment; Procedure: Standard Hospital/clinic-based Care Monitoring; Drug: Aflibercept 2Mg/0.05Ml Inj,Oph

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.

• Study Type: Interventional
• Enrollment (Estimated): 308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yingfeng Zheng, MD, PhD; Phone Number: +8613922286455; Email: zhyfeng@mail.sysu.edu.cn
• Study Contact Backup: Name: Zitian Liu, MD, PhD; Email: liuzt25@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China
      • Recruiting
      • Dongguan Guangming Ophthalmic Hospital
      • Contact: Liangqi Feng, MD; Phone Number: +18925886240; Email: 443756110@qq.com
      • Principal Investigator: Qiang Yu, MD, PhD
    • Foshan, Guangdong, China
      • Recruiting
      • The Second Peoples Hospital of Foshan
      • Contact: Xiao Hu, MD, PhD; Phone Number: +8613922286455; Email: huxiao0127@hotmail.com
      • Principal Investigator: Xiangbin Kong, MD, PhD
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Yingfeng Zheng, MD, PhD; Phone Number: +8613922286455; Email: zhyfeng@mail.sysu.edu.cn
      • Contact: Zitian Liu, MD, PhD; Email: liuzt25@mail.sysu.edu.cn
      • Principal Investigator: Yingfeng Zheng, MD, PhD
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The First Affiliated Hospital of Jinan University
      • Contact: Jiaqi Lu, MD; Phone Number: 020-38688116; Email: 937855925@qq.com
      • Principal Investigator: Jinglin Zhang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Participant-level Criteria:

Inclusion 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 Criteria:

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

Exclusion Criteria:

The following exclusions apply to the study eye only (i.e., they may be present for the non-study eye):

• 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 normal
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; 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.; 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.; Other Names: Aflibercept 2-mg/0.05mL intravitreal ophthalmic injection
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.	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.; 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.; Other Names: Aflibercept 2-mg/0.05mL intravitreal ophthalmic injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the randomization visit to 96 week visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from the randomization visit to 96 week visit
Proportion of study eyes with at least 5, 10 and 15 letter gains or losses in visual acuity	Proportion of study eyes with at least 5, 10 and 15 letter gains or losses in visual acuity from the randomization visit to 96 week visit. Distribution of visual acuity outcomes (20/20 or better; 20/25 or better; 20/40 or better; 20/80 or better; 20/200 or better) will also be described.	from the randomization visit to 96 week visit
Change in OCT central subfield thickness	OCT examinations will be conducted by masked, experienced technicians. The same machine type should be used throughout the study for each participant. The outcomes include change in OCT central subfield thickness and retinal volume.	from the randomization visit to 96 week visit
Change in OCT retinal volume	OCT examinations will be conducted by masked, experienced technicians. The same machine type should be used throughout the study for each participant. The outcomes include change in OCT central subfield thickness and retinal volume.	from the randomization visit to 96 week visit
Long lapses in care	Lapse in care will be defined as more than 2 weeks past the target date for a visit that is scheduled either 4 or 8 weeks after a completed visit or more than 4 weeks past the target date for a visit scheduled 16 or more weeks after a completed visit. Detailed definition is provided in the protocol.	from the randomization visit to 96 week visit
Ability to Work and Perform Regular Activities	The Work Productivity and Activity Impairment Questionnaire Global Health (WPAI-GH, Simplified Chinese version) will be used to evaluate the ability to work and perform regular activities. The WPAI-GH is a validated survey tool that consists of 6 questions assessing the impact of health problems on work performance and on regular daily activities outside of work.	from the randomization visit to 96 week visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic analysis (Cost-utility ratio)	Costs and Utilities will be calculated over the duration of the trial. The incremental cost-utility ratio (ICUR) will be calculated by taking the incremental cost of the home-based care model over the hospital/clinic-based care model and dividing them by the incremental utilities of home-based care model over hospital/clinic-based care model. A probabilistic sensitivity analysis will be conducted to better characterize overall uncertainty in the results. Details are provided in the statistical analysis protocol (SAP).	from the randomization visit to 96 week visit
Change in best-corrected visual acuity (letter score) in the non-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. Data in the non-study eyes will be analyzed.	From the randomization visit to 96 week visit
Change in best-corrected visual acuity (letter score) in the study eyes from the randomization visit to 48 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. Proportion of study eyes with at least 5, 10 and 15 letter gains or losses in visual acuity, distribution of visual acuity outcomes (20/20 or better; 20/25 or better; 20/40 or better; 20/80 or better; 20/200 or better) from the randomization visit to 48 week visit will also be described.	From the randomization visit to 48 week visit
Change in OCT retinal volume from the randomization visit to 48 week visit	OCT examinations will be conducted by masked, experienced technicians. The same machine type should be used throughout the study for each participant. The outcomes include change in OCT central subfield thickness and retinal volume.	from the randomization visit to 48 week visit
Change in OCT central subfield thickness from the randomization visit to 48 week visit	OCT examinations will be conducted by masked, experienced technicians. The same machine type should be used throughout the study for each participant. The outcomes include change in OCT central subfield thickness and retinal volume.	from the randomization visit to 48 week visit
Long lapses in care from the randomization visit to 48 week visit	Lapse in care will be defined as more than 2 weeks past the target date for a visit that is scheduled either 4 or 8 weeks after a completed visit or more than 4 weeks past the target date for a visit scheduled 16 or more weeks after a completed visit. Detailed definition is provided in the protocol.	from the randomization visit to 48 week visit
Ability to Work and Perform Regular Activities from the randomization visit to 48 week visit	The Work Productivity and Activity Impairment Questionnaire Global Health (WPAI-GH, Simplified Chinese version) will be used to evaluate the ability to work and perform regular activities. The WPAI-GH is a validated survey tool that consists of 6 questions assessing the impact of health problems on work performance and on regular daily activities outside of work.	from the randomization visit to 48 week visit
Change in superficial capillary vessel density (SVD) in the study eyes	The vessel density of the superfcial capillary plexus level will be analyzed in the 3x3 mm OCTA scanning mode (Zeiss Cirrus HD-OCT).	Baseline, 4, 8, 12, 16 (randomization), 24, 48, 72, 96 week visit
Change in deep capillary vessel density (DVD) in the study eyes	The vessel density of the deep capillary plexus level will be analyzed in the 3x3 mm OCTA scanning mode (Zeiss Cirrus HD-OCT).	Baseline, 4, 8, 12, 16 (randomization), 24, 48, 72, 96 week visit
Change in foveal avascular zone (FAZ) in the study eyes	The area of foveal avascular zone will be analyzed in the 3x3 mm OCTA scanning mode (Zeiss Cirrus HD-OCT).	Baseline, 4, 8, 12, 16 (randomization), 24, 48, 72, 96 week visit
Change in non-perfusion (NP) in the study eyes	The NP regions in the superficial and deep capillary plexus were will be evaluated on the 3x3 mm OCTA Image.	Baseline, 4, 8, 12, 16 (randomization), 24, 48, 72, 96 week visit

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Collaborators: The Second People's Hospital of Foshan; Dongguan Guangming Ophthalmic Hospital
• Investigators: Principal Investigator: Yingfeng Zheng, MD, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• Wells JA, Glassman AR, Ayala AR, Jampol LM, Bressler NM, Bressler SB, Brucker AJ, Ferris FL, Hampton GR, Jhaveri C, Melia M, Beck RW; Diabetic Retinopathy Clinical Research Network. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology. 2016 Jun;123(6):1351-9. doi: 10.1016/j.ophtha.2016.02.022. Epub 2016 Feb 27.
• Elman MJ, Ayala A, Bressler NM, Browning D, Flaxel CJ, Glassman AR, Jampol LM, Stone TW; Diabetic Retinopathy Clinical Research Network. Intravitreal Ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: 5-year randomized trial results. Ophthalmology. 2015 Feb;122(2):375-81. doi: 10.1016/j.ophtha.2014.08.047. Epub 2014 Oct 28.
• Diabetic Retinopathy Clinical Research Network; Wells JA, Glassman AR, Ayala AR, Jampol LM, Aiello LP, Antoszyk AN, Arnold-Bush B, Baker CW, Bressler NM, Browning DJ, Elman MJ, Ferris FL, Friedman SM, Melia M, Pieramici DJ, Sun JK, Beck RW. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015 Mar 26;372(13):1193-203. doi: 10.1056/NEJMoa1414264. Epub 2015 Feb 18.
• Reddy RK, Pieramici DJ, Gune S, Ghanekar A, Lu N, Quezada-Ruiz C, Baumal CR. Efficacy of Ranibizumab in Eyes with Diabetic Macular Edema and Macular Nonperfusion in RIDE and RISE. Ophthalmology. 2018 Oct;125(10):1568-1574. doi: 10.1016/j.ophtha.2018.04.002. Epub 2018 May 8.
• Jhaveri CD, Glassman AR, Ferris FL 3rd, Liu D, Maguire MG, Allen JB, Baker CW, Browning D, Cunningham MA, Friedman SM, Jampol LM, Marcus DM, Martin DF, Preston CM, Stockdale CR, Sun JK; DRCR Retina Network. Aflibercept Monotherapy or Bevacizumab First for Diabetic Macular Edema. N Engl J Med. 2022 Aug 25;387(8):692-703. doi: 10.1056/NEJMoa2204225. Epub 2022 Jul 14.
• Heier JS, Korobelnik JF, Brown DM, Schmidt-Erfurth U, Do DV, Midena E, Boyer DS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Vitti R, Berliner AJ, Zeitz O, Metzig C, Holz FG. Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies. Ophthalmology. 2016 Nov;123(11):2376-2385. doi: 10.1016/j.ophtha.2016.07.032. Epub 2016 Sep 17.
• Glassman AR, Wells JA 3rd, Josic K, Maguire MG, Antoszyk AN, Baker C, Beaulieu WT, Elman MJ, Jampol LM, Sun JK. Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study). Ophthalmology. 2020 Sep;127(9):1201-1210. doi: 10.1016/j.ophtha.2020.03.021. Epub 2020 Mar 29.
• Kim JE, Tomkins-Netzer O, Elman MJ, Lally DR, Goldstein M, Goldenberg D, Shulman S, Benyamini G, Loewenstein A. Evaluation of a self-imaging SD-OCT system designed for remote home monitoring. BMC Ophthalmol. 2022 Jun 10;22(1):261. doi: 10.1186/s12886-022-02458-z.
• Liu Z, Huang W, Wang Z, Jin L, Congdon N, Zheng Y, Chen S, Liu Y. Evaluation of a self-imaging OCT for remote diagnosis and monitoring of retinal diseases. Br J Ophthalmol. 2024 Jul 23;108(8):1154-1160. doi: 10.1136/bjo-2023-324012.
• Maguire MG, Liu D, Bressler SB, Friedman SM, Melia M, Stockdale CR, Glassman AR, Sun JK; DRCR Retina Network. Lapses in Care Among Patients Assigned to Ranibizumab for Proliferative Diabetic Retinopathy: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Dec 1;139(12):1266-1273. doi: 10.1001/jamaophthalmol.2021.4103.
• Greco G, Pistilli M, Asbell PA, Maguire MG; Dry Eye Assessment and Management Study Research Group. Association of Severity of Dry Eye Disease with Work Productivity and Activity Impairment in the Dry Eye Assessment and Management Study. Ophthalmology. 2021 Jun;128(6):850-856. doi: 10.1016/j.ophtha.2020.10.015. Epub 2020 Oct 15.
• Bressler NM, Chang TS, Suner IJ, Fine JT, Dolan CM, Ward J, Ianchulev T; MARINA and ANCHOR Research Groups. Vision-related function after ranibizumab treatment by better- or worse-seeing eye: clinical trial results from MARINA and ANCHOR. Ophthalmology. 2010 Apr;117(4):747-56.e4. doi: 10.1016/j.ophtha.2009.09.002. Epub 2010 Mar 2.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Aflibercept; Diabetic macular edema; Diabetic retinopathy; Anti-VEGF; Best-corrected visual acuity; Home care monitoring; Home OCT; Visit burden
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Diabetic Retinopathy; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; aflibercept; Laser Therapy
• Other Study ID Numbers: 2024KYPJ072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No