PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME
Condition: Diabetic Retinopathy; Macular Edema
MeSH terms: Macular Edema; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): PPV/MP; Intravitreal injection
Intervention type(s): Procedure; Drug
Intervention description(s): 23 gauge Pars Plana Vitrectomy with Internal Limiting Membrane Peeling; Intravitreal ziv-Aflibercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment