Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy
- Conditions
- Exudative Age Related Macular Degeneration
- Interventions
- Device: Photodynamic laser treatment (PDT)
- Registration Number
- NCT04075136
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Willing to give written informed consent
- Willing and able to comply with all study procedures for the duration of the study.
- Presence of Exudative ARMD with evidence of choroidal neovascularization: type 1, 2, and/or 3 on spectral domain OCT, fluorescein angiography, indocyanine green angiogram and optical coherent tomography angiography
- Visual Acuity of 20/25 to 20/400 at screening and baseline visits using an autorefractor or Early Treatment Diabetic Retinopathy Study
- Intraocular pressure less than or equal to 25mmHG
- Females of childbearing potential that are willing to use medically acceptable methods of birth control.
- Exudation maculopathies without drusen
- Previous treatment with macular photocoagulation, anti-VEGF medication or PDT with Visudyne
- Myocardial infarction or cerebrovascular accident within the last 6 weeks
- Previous vitrectomy
- Optic neuropathy
- Diabetic retinopathy
- Traction maculopathies
- Allergies to fluorescein and indocyanine, dilating agents or anti-VEGF medications
- Have received previous treatment for ARMD
- Any uncontrolled condition or illness that in the opinion of the investigator makes the subject unsuitable for the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Lucentis & PDT Laser Photodynamic laser treatment (PDT) A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence. Arm C: Lucentis, PDT Laser and Triescense Photodynamic laser treatment (PDT) 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. Arm C: Lucentis, PDT Laser and Triescense Triamcinolone Acetonide 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. Arm C: Lucentis, PDT Laser and Triescense verteporfin 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. Arm A: Lucentis Ranibizumab A standard of care treatment of 0.05ml/0.5mg Lucentis given every 4 weeks for 48 weeks. Arm B: Lucentis & PDT Laser Ranibizumab A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence. Arm B: Lucentis & PDT Laser verteporfin A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence. Arm C: Lucentis, PDT Laser and Triescense Ranibizumab 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 Measures
Name Time Method Percentage of subretinal exudation resolution 6 months The percentage of subretinal exudation resolution
Percentage of intraretinal exudation resolution 6 months The percentage of intraretinal exudation resolution
- Secondary Outcome Measures
Name Time Method Percentage of intraretinal exudation resolution 12 months Intraretinal exudation resolution
Percentage of subretinal exudation resolution 12 months Subretinal exudation resolution
Best corrected visual acuity (BCVA) 12 months Best corrected visual acuity
Duration of treatment effect Up to 6 months Duration of treatment effect
Foveal thickness 12 Months Measured using Optical coherence tomography (OCT)
Trial Locations
- Locations (1)
Wake Forest Health Sciences
🇺🇸Winston-Salem, North Carolina, United States