Viewing Study NCT03321513



Ignite Creation Date: 2024-05-06 @ 10:41 AM
Last Modification Date: 2024-10-26 @ 12:33 PM
Study NCT ID: NCT03321513
Status: COMPLETED
Last Update Posted: 2024-04-25
First Post: 2017-10-23

Brief Title: DRCRNet Aflibercept vs Bevacizumab Deferred Aflibercept for the Treatment of CI-DME
Sponsor: Jaeb Center for Health Research
Organization: Jaeb Center for Health Research

Study Overview

Official Title: Randomized Trial of Intravitreous Aflibercept Versus Intravitreous Bevacizumab Deferred Aflibercept for Treatment of Central-Involved Diabetic Macular Edema
Status: COMPLETED
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DRCR AC
Brief Summary: Both aflibercept and bevacizumab have been shown to improve vision in eyes with DME In eyes with DME and at least moderate vision loss both aflibercept and bevacizumab were also shown to be successful in many eyes However aflibercept was shown to be more effective at improving vision on average at 1 year and at 2 years Due to the large cost difference between the two drugs many clinicians and patients are choosing to initiate treatment with bevacizumab and then switch to aflibercept depending on the eyes response to bevacizumab treatment However there is no scientific evidence that this treatment strategy is as effective at improving vision as initiating treatment with aflibercept Patients and clinicians do not know if this approach ultimately has deleterious effects on visual acuity If starting with aflibercept is not better than starting with bevacizumab and switching to aflibercept if needed the potential cost savings to future patients and the health care system would be substantial However if starting with aflibercept is better then patients clinicians and health care providers can make informed decisions for how to best treat patients with DME and at least moderate vision loss

Study Objectives To compare the efficacy of intravitreous aflibercept with intravitreous bevacizumab deferred aflibercept if needed in eyes with CI DME and moderate vision loss
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None