Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04075136
Phase
PHASE4
Status
Withdrawn

Conditions

  • Exudative Age Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Intravitreal injection 0.5 MG Per 0.05 ML Injection.
  • Photodynamic laser treatment (PDT) — DEVICE
    PDT light dose of 50 J/cm2 of neovascular lesion administered at an intensity of 600mW/cm2. A Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area. PDT will be administered at half-fluence - measured by time, i.e. 42 seconds as opposed to full-fluence which is 83 seconds.
  • Triamcinolone Acetonide — DRUG
    Intravitreal injection of 0.5ml-2mg
  • verteporfin — DRUG
    Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.

Study Details

Optical Coherent Tomography Angiography (OCTA)-Directed PDT Triple Therapy for Treatment-Naïve Patients with Exudative Age-related Macular Degeneration (ARMD) versus Standard of Care Anti-VEGF Monotherapy

Key Dates

Start date
Mar 30, 2023
Status verified
Apr 2023
Primary completion
Nov 30, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Active Comparator: Arm A: Lucentis
    A standard of care treatment of 0.05ml/0.5mg Lucentis given every 4 weeks for 48 weeks.
  • Experimental: Arm B: Lucentis & PDT Laser
    A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence.
  • Experimental: Arm C: Lucentis, PDT Laser and Triescense
    A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence and an intravitreal injection of 0.5ml-2mg Triescence at the time of PDT treatment.

Primary Outcome Measure

Percentage of subretinal exudation resolution [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Health SciencesWinston-SalemNorth Carolina27157-

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Wake Forest Health Sciences· Winston-Salem, NC