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

• Status: Withdrawn
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Bausch & Lomb Incorporated
• Treatments: Aflibercept; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide; Verteporfin

Criteria

Inclusion Criteria:

• Clinical diagnosis of either 1) NV AMD with PDA in spite of standard-of-care intravitreal anti-VEGF therapy, either loading dose or maintenance therapy or 2) Clinical diagnosis of NV AMD with Progressive Disease in spite of standard-of-care intravitreal anti-VEGF therapy, either loading dose or maintenance therapy

• Best-corrected visual acuity equivalent of 20/25-20/320

• Able to provide written informed consent

• Presence of discernible choroidal neovascular lesion by ICG angiography

Exclusion Criteria:

• History of porphyria or sensitivity to any component of verteporfin preparation

• Presence of systemic fungal infection or sensitivity to any component of triamcinolone acetonide preparation

• Presence of ocular or periocular infection or sensitivity to any component to aflibercept

• Prior vitrectomy surgery

• Prior thermal laser for macular photocoagulation

• Inability to avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days following verteporfin PDT treatment sessions

• Presence of large submacular hemorrhage in association with choroidal neovascular lesion

• Known or suspected allergy to fluorescein and/or indocyanine green

• Known history of open angle glaucoma

• Known history of diabetic macular edema or macular edema attributable to central retinal vein occlusion

• Recent history (within prior 6 months) of cerebrovascular accident (i.e. stroke) or myocardial infarction.