drugset / Trial / NCT02457026

Adjunctive Photodynamic Therapy + Aflibercept vs. Afilbercept Alone for PDA in NV AMD

NCT02457026

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this prospective interventional study is to assess whether adjunctive verteporfin photodynamic therapy (PDT) is effective for the treatment of persistent disease activity in neovascular age-related macular degeneration (NV AMD), as compared to anti-VEGF therapy (aflibercept) alone. This study will enroll individuals with NV AMD who have persistent disease activity in spite of either loading dose (initial 3-5 anti-VEGF treatments) or maintenance (established course) anti-VEGF therapy to determine whether PDT can improve disease activity, facilitate sustained visual acuity gains, and decrease burden of frequent anti-VEGF treatments for affected patients. Risks of study are related to treatment with study drugs: intravenous verteporfin, intravitreal triamcinolone acetonide, and intravitreal aflibercept. All have been studied extensively in clinical trials and are established treatments used routinely in NV AMD. Adverse events will be monitored by the principal investigator and study team.

Timeline

Start
2016-01
Primary completion
2018-01
Completion
2018-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Triamcinolone Acetonide Other / unclassified Intravitreal
Subject Verteporfin Other / unclassified Intravenous
Background Aflibercept Protein / enzyme biologic Intravitreal