Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause
acute and dramatic vision loss for patients with diabetes, there is no current,
evidence-based clinical guidance as to what treatment method is most likely to provide the
best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial
growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each
provide the opportunity to stabilize or regress retinal neovascularization. However, clinical
trials are lacking to elucidate the relative time frame of visual recovery or final visual
outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic
Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent
with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including
greater visual acuity improvement and reduced rates of recurrent VH as compared with saline
injection. It is possible that a study with a longer duration of follow-up with structured
anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to
avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the
other hand, advances in surgical techniques leading to faster operative times, quicker
patient recovery, and reduced complication rates may make prompt vitrectomy a more attractive
alternative since it results in the immediate ability to clear hemorrhage and to perform PRP
if desired, often as part of one procedure. This proposed study will evaluate the safety and
efficacy of two treatment approaches for eyes with VH from PDR: prompt vitrectomy + PRP and
intravitreous aflibercept injections.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Jaeb Center for Health Research
Collaborators:
National Eye Institute (NEI) National Institutes of Health (NIH) Regeneron Pharmaceuticals