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

NCT06610747 | Recruiting DMC

• 1 other identifier: 2024KYPJ072
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edema; Diabetic retinopathy; Aflibercept; Anti-VEGF; Home care monitoring; Home OCT; Best-corrected visual acuity; Visit burden; Randomized clinical trial

Outcome Measures

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.

  From the randomization visit to 96 week visit

Secondary Outcomes (6)

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

  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

  from the randomization visit to 96 week visit

• Change in OCT central subfield thickness

  from the randomization visit to 96 week visit

• Change in OCT retinal volume

  from the randomization visit to 96 week visit

• Long lapses in care

  from the randomization visit to 96 week visit

Other Outcomes (11)

• Economic analysis (Cost-utility ratio)

  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

  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

  From the randomization visit to 48 week visit

Study Arms (2)

Home-based care group

EXPERIMENTAL

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; Drug: Aflibercept 2Mg/0.05Ml Inj,Oph; Procedure: Laser Treatment

Standard Hospital/clinic-based care group

ACTIVE COMPARATOR

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.

Drug: Aflibercept 2Mg/0.05Ml Inj,Oph; Procedure: Laser Treatment; Procedure: Standard Hospital/clinic-based Care Monitoring

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.

Home-based care group

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.

Also known as: Aflibercept 2-mg/0.05mL intravitreal ophthalmic injection

Home-based care group; Standard Hospital/clinic-based care group

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.

Home-based care group; Standard Hospital/clinic-based care group

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.

Standard Hospital/clinic-based care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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:
• 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)
• 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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead
• Dongguan Guangming Ophthalmic Hospital: collaborator
• The Second People's Hospital of Foshan: collaborator

Study Sites (3)

Dongguan Guangming Ophthalmic Hospital

Dongguan, Guangdong, China

RECRUITING

The Second Peoples Hospital of Foshan

Foshan, Guangdong, China

RECRUITING

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 29752001 BACKGROUND

• 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.

  PMID: 35833805 BACKGROUND

• 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.

  PMID: 27651226 BACKGROUND

• 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.

  PMID: 25692915 BACKGROUND

• 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.

  PMID: 26935357 BACKGROUND

• 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.

  PMID: 32402554 BACKGROUND

• 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.

  PMID: 35689210 BACKGROUND

• 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.

  PMID: 37903558 BACKGROUND

• 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.

  PMID: 34673898 BACKGROUND

• 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.

  PMID: 33068617 BACKGROUND

• 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.

  PMID: 20189654 BACKGROUND

• 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.

  PMID: 25439614 RESULT

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

aflibercept; Laser Therapy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Yizhi Liu, MD, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Yingfeng Zheng, MD, PhD

CONTACT

+8613922286455; zhyfeng@mail.sysu.edu.cn

Zitian Liu, MD, PhD

CONTACT

liuzt25@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 24, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 22, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)