Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610747
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema Non-inferiority RCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Home Care Monitoring of Visual Acuity and OCT Versus Standard HospitalClinic Care Monitoring During Diabetic Macular Edema Management A Non-inferiority Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DME HOME
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 eg 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 patients39 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
Recently portable self-administered Home OCT devices have been developed that allow for home-based OCT scanning of retinal diseases eg 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 patients39 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 eg 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 hospitalclinic-based care among DME participants receiving anti-VEGF therapy and if it is non-inferior to determine if the home care model can reduce hospitalclinic 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 Hospitalclinic-based Care Group
Re-injections of anti-VEGF PRN laser surgery or other procedures will be performed per protocol for participants from both groups
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 eg 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 hospitalclinic-based care among DME participants receiving anti-VEGF therapy and if it is non-inferior to determine if the home care model can reduce hospitalclinic 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 Hospitalclinic-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None