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
This study is a 48 week, single center, randomized controlled clinical trial. Approximately 150 subjects will be randomized into three separate arms. This study compares the efficacy of standard of care Lucentis (ranibizumab) monotherapy versus OCTA-Directed PDT Triple Therapy with Lucentis (ranibizumab), PDT with Visudyne (verteporfin), and Triescence (triamcinolone acetonide) in treatment-naïve patients with Exudative Age-Related Macular Degeneration. OCTA-Directed PDT Double Therapy with Lucentis (ranibizumab) and PDT with Visudyne (verteporfin) will also be tested to confirm the hypothesis that steroids are necessary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Intravitreal injection 0.5 MG Per 0.05 ML Injection.
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.
Intravitreal injection of 0.5ml-2mg
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States
Percentage of subretinal exudation resolution
The percentage of subretinal exudation resolution
Time frame: 6 months
Percentage of intraretinal exudation resolution
The percentage of intraretinal exudation resolution
Time frame: 6 months
Percentage of subretinal exudation resolution
Subretinal exudation resolution
Time frame: 12 months
Percentage of intraretinal exudation resolution
Intraretinal exudation resolution
Time frame: 12 months
Best corrected visual acuity (BCVA)
Best corrected visual acuity
Time frame: Baseline
Best corrected visual acuity (BCVA)
Best corrected visual acuity
Time frame: 12 months
Duration of treatment effect
Duration of treatment effect
Time frame: Up to 6 months
Foveal thickness
Measured using Optical coherence tomography (OCT)
Time frame: Baseline
Foveal thickness
Measured using Optical coherence tomography (OCT)
Time frame: 12 Months
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Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.