Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Intravitreous Anti-VEGF vs. Prompt Vitrectomy for Vitreous Hemorrhage From Proliferative Diabetic Retinopathy
Brief Summary: 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.


Options:
A: Arm Label: 7 days; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bevacizumab | Arm Label: 20 days; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bevacizumab | Arm Label: sham; Type: SHAM_COMPARATOR; Interventions: Other: sham | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): 20 days, 7 days | Intervention Type: OTHER; Name: sham; Assigned to Arm(s): sham
B: Arm Label: Intravitreous 2 mg aflibercept injections; Type: ACTIVE_COMPARATOR; Interventions: Drug: 2-mg Intravitreous Aflibercept Injection | Arm Label: Prompt vitrectomy plus panretinal photocoagulation; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Prompt Vitrectomy Plus Panretinal Photocoagulation | Intervention Type: DRUG; Name: 2-mg Intravitreous Aflibercept Injection; Assigned to Arm(s): Intravitreous 2 mg aflibercept injections | Intervention Type: PROCEDURE; Name: Prompt Vitrectomy Plus Panretinal Photocoagulation; Assigned to Arm(s): Prompt vitrectomy plus panretinal photocoagulation
C: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Bevacizumab, Procedure: pars plana vitrectomy | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Procedure: pars plana vitrectomy | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): A | Intervention Type: PROCEDURE; Name: pars plana vitrectomy; Assigned to Arm(s): A, B
D: Arm Label: Group I; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aflibercept Injection [Eylea] | Arm Label: Group II: Early vitrectomy.; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Vitrectomy | Intervention Type: DRUG; Name: Aflibercept Injection [Eylea]; Assigned to Arm(s): Group I | Intervention Type: PROCEDURE; Name: Vitrectomy; Assigned to Arm(s): Group II: Early vitrectomy.

Answer: B