NCT01805297

Aflibercept Injection for Proliferative Diabetic Retinopathy

Intravitreal Aflibercept Injection as a Surgical Adjuvant in Severe Proliferative Diabetic Retinopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.

Detailed description

Patients who need Pars Plana Vitrectomy surgery, and agree to participate in this study will receive an injection of 2.0mg aflibercept 4 to 6 days before Vitrectomy surgery. Half of these patients will be randomized to receive another injection of 2.0mg aflibercept immediately after their surgery. Postoperative patient visits in this study will be at 1 day, and at weeks 1, 4, 16 and 24, and at any other times as deemed necessary by the Investigator.

Conditions

• Vitreous Hemorrhage

Interventions

Type	Name	Description
DRUG	Intravitreal Aflibercept Injection	One time 2.0mg aflibercept injection, following pars plana vitrectomy.
OTHER	Standard Vitrectomy	Surgical intervention

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-02-01
• Completion: 2015-11-01
• First posted: 2013-03-06
• Last updated: 2023-12-27
• Results posted: 2017-09-13

Locations

1 site across 1 country: United States