drugset / Trial / NCT02976012

Endolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH

NCT02976012

Phase 1/2 Unknown 24 enrolled Southeast Retina Center, Georgia
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will receive one preoperative intravitreal aflibercept injection (IAI) \<21 days but \>7 days prior to vitrectomy and one intraoperative IAI at end of surgery followed by randomization in a 1:1 ratio into either 4 mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative q4weeks IAI followed by mandatory q16 weeks IAI for 52 weeks follow-up (q16 week Group).

Timeline

Start
2016-06
Primary completion
2018-06
Completion
2018-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aflibercept Protein / enzyme biologic 2 mg Intravitreal