Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Diabetic Retinopathy
  • Macular Edema
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 90 years
Gender
Both males and females

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 co...

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.

Tracking Information

NCT #
NCT03660345
Collaborators
Not Provided
Investigators
Not Provided