NCT02858076

Anti-VEGF vs. Prompt Vitrectomy for VH From PDR

Intravitreous Anti-VEGF vs. Prompt Vitrectomy for Vitreous Hemorrhage From Proliferative Diabetic Retinopathy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A participant could have only one eye enrolled in the study.

Conditions

• Proliferative Diabetic Retinopathy
• Vitreous Hemorrhage

Interventions

Type	Name	Description
DRUG	2-mg Intravitreous Aflibercept Injection	Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
PROCEDURE	Prompt Vitrectomy Plus Panretinal Photocoagulation	Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2016-08-08
• Last updated: 2021-04-20
• Results posted: 2021-01-19

Locations

62 sites across 2 countries: United States, Canada