Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03660345
Study type Interventional
Source Rush Eye Associates
Contact
Status Completed
Phase Phase 3
Start date September 4, 2018
Completion date May 4, 2021

See also
  Status Clinical Trial Phase
Completed NCT03660371 - ILM Peeling in PDR Patients Undergoing PPV for VH N/A
Completed NCT03660384 - Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy N/A
Completed NCT04905459 - ARDA Software for the Detection of mtmDR
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT05022615 - Comparing 3 Imaging Systems
Completed NCT00385333 - Metabolic Mapping to Measure Retinal Metabolism Phase 2
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Completed NCT03702374 - Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy Phase 3
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT04009980 - Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus. N/A
Completed NCT02924311 - Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Not yet recruiting NCT06257082 - Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities N/A
Not yet recruiting NCT05452993 - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography N/A
Withdrawn NCT02812030 - Aflibercept for Retinopathy in the Real World N/A
Completed NCT02391558 - Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography N/A
Active, not recruiting NCT02330042 - OCT Biomarkers for Diabetic Retinopathy
Active, not recruiting NCT02353923 - OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy N/A
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT01950663 - RETeval Study for Diabetic Retinopathy N/A