Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03660345 |
Other study ID # |
Retina 1 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
September 4, 2018 |
Est. completion date |
May 4, 2021 |
Study information
Verified date |
November 2021 |
Source |
Rush Eye Associates |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Treatment-naïve subjects with center-involved diabetic macular edema undergoing pars plana
vitrectomy with internal limiting membrane peeling will have similar visual outcomes but
better anatomical outcomes compared to subjects undergoing intravitreal bevacizumab
monotherapy at one year.
Description:
Diabetic retinopathy is the number one cause of vision loss in working-age adults, and
macular edema is the most frequent cause of visual impairment in diabetic patients. Diabetic
macular edema (DME) has been treated by a number of different modalities including focal and
grid laser, intravitreal corticosteroids, intravitreal anti-vascular endothelial growth
factor (VEGF) medications, and pars plana vitrectomy (PPV) with or without internal limiting
membrane peeling.
PPV for the treatment of DME was first described in 1992 by Lewis et al, and since then has
been studied by numerous investigators under a variety of different clinical settings
including the presence of epiretinal membranes, vitreomacular traction (VMT), and diffuse
DME. The postulated mechanisms by which PPV may improve DME have included a reduction in
macular tangential and anterior-posterior traction, improved oxygenation of the vitreous
cavity, and enhanced diffusion of vasogenic growth factors. Other factors that may modulate
the response to PPV comprise the patient's lens status and the presence of macular ischemia.
PPV for DME has usually been considered only in patients that responded poorly to other
interventions such as laser and/or intravitreal therapy. Typically, such patients have
chronic and diffuse DME with, or without, concomitant VMT. Several small prospective,
controlled trials have been performed to assess the merits of PPV as a treatment option for
such recalcitrant cases with generally disappointing functional outcomes despite having
structural improvements. However, since PPV was reserved as a last-ditch effort following a
long ordeal with what included multiple lasers and/or intravitreal injections, it should not
be surprising that visual outcomes were poor under such circumstances. Presumably most of
these patients already would have had irreversible damage to the retina with little or no
potential for visual acuity improvement no matter what the intervention might have been.
Currently, there are no reports in the literature evaluating PPV as an initial treatment for
DME. In this study, we compare PPV to anti-VEGF monotherapy in treatment-naïve subjects with
DME in order to evaluate the potential role of PPV in the management of DME before
irreversible retinal damage caused by long-standing and persistent DME has set in.