NCT02630277

Evaluation of Treatment of High riSk proLiferative Diabetic retinopathY With Intravitreal Aflibercept injectioN

Evaluation of Treatment of High riSk proLiferative Diabetic retinopathY With Intravitreal Aflibercept Injection (ELYSIAN)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Valley Retina Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of intravitreal aflibercept injection in the regression of retinal neovascularization secondary to high-risk PDR. To characterize baseline/post-induction/maintenance levels of proinflammatory mediators in patients with high-risk PDR

Detailed description

This study will evaluate two dosing regimens (monthly and PRN following a loading dose) for treatment of PDR with intravitreal aflibercept injection. Additionally, the study will identify biomarker mediators in vitreous fluid present at baseline in patients with PDR and will track over the course of a year their profile changes in response to these two dosing regimens. The treatment regimens will provide information on the biomarker profile with a monthly regimen as well as with a variable regimen. Furthermore, biomarker mediators that may be associated with anti-VEGF responders and non-responders may also be identified. 105 biomarker mediators (cytokines/chemokines) which have been identified as playing a role in PDR in published studies will be profiled in patients with PDR.

Conditions

• Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Aflibercept	Intravitreal Aflibercept Injection 2.0 mg

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-01-01
• Completion: 2017-06-01
• First posted: 2015-12-15
• Last updated: 2015-12-15