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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT02457026
Status
Withdrawn

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept — DRUG
    Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1.
  • Triamcinolone Acetonide — DRUG
    Triamcinolone Acetonide is a synthetic corticosteroid indicated for treatment of ocular inflammatory conditions, uveitis, sympathetic ophthalmia, and temporal arteritis.
  • Verteporfin — DRUG
    Verteporfin is a benzoporphyrin derivative, and is a medication used as a photosensitizer for photodynamic therapy.

Study Details

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.

Key Dates

Start date
Jan 31, 2016
Status verified
Jul 2017
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adjunctive PDT + Aflibercept
    Participants will receive adjunctive verteporfin PDT at Study Visit 1 as well as intravitreal aflibercept at Study Visits 1, 2, 3. At Study Visit 4, participants will have repeat assessment of disease activity. If disease activity is resolved or trivial, the individual will be maintained on aflibercept injections. If PDA remains unresolved, the individual will undergo repeat verteporfin PDT at Study Visit 4, as well as intravitreal aflibercept at Study Visits 4, 5, and 6. Disease activity will be reassessed at Study Visit 7. If disease activity is resolved or trivial, the individual will be switched to aflibercept injections once every three months. If PDA remains unresolved, then the individual will default to a standard-of-care treatment strategy with aflibercept (monthly injections).
  • Active Comparator: Aflibercept Alone
    Participants in this group will receive intravitreal aflibercept at Study Visits 1, 2, and 3. At Study Visit 4, participants will have repeat assessment of disease activity. From Study Visit 4 onwards, aflibercept will be administered according to a "treat-and-extend" strategy. If disease activity is considered to be resolved or trivial, then the interval between treatments can be initially "extended" from every 28 days to every 42 days. If disease activity remains stable, treatments can be extended in 14-day increments, up to 10 weeks between treatments. For individuals who have PDA that remains unresolved, aflibercept will continue to be administered every days, but if disease quiescence is achieve at a later time point, the treatment period can be extended at that time.

Primary Outcome Measure

Percentage of individuals with resolution or major reduction in PDA [ Time Frame: up to 8 weeks after loading dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Eye CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke Eye Center· Durham, NC

Related Studies