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

Study Overview
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Brief Summary
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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
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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.

Official Title
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OCTA-Directed PDT Triple Therapy for Treatment-Naïve Patients With Exudative Age-Related Macular Degeneration Versus Standard of Care Anti-VEGF(Anti-vascular Endothelial Growth Factor) Monotherapy

Conditions
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Exudative Age Related Macular Degeneration

Intervention / Treatment
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* Drug: Ranibizumab
* Device: Photodynamic laser treatment (PDT)
* Drug: Triamcinolone Acetonide
* Drug: verteporfin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A: Lucentis<br>A standard of care treatment of 0.05ml/0.5mg Lucentis given every 4 weeks for 48 weeks. | Drug: Ranibizumab<br>* Intravitreal injection 0.5 MG Per 0.05 ML Injection.<br>* Other names: Lucentis;|
| Experimental: Arm B: Lucentis & PDT Laser<br>A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence. | Drug: Ranibizumab<br>* Intravitreal injection 0.5 MG Per 0.05 ML Injection.<br>* Other names: Lucentis;Device: Photodynamic laser treatment (PDT)<br>* 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.<br>Drug: verteporfin<br>* Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.<br>* Other names: Visudyne;|
| Experimental: Arm C: Lucentis, PDT Laser and Triescense<br>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. | Drug: Ranibizumab<br>* Intravitreal injection 0.5 MG Per 0.05 ML Injection.<br>* Other names: Lucentis;Device: Photodynamic laser treatment (PDT)<br>* 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.<br>Drug: Triamcinolone Acetonide<br>* Intravitreal injection of 0.5ml-2mg<br>* Other names: Triesence;Drug: verteporfin<br>* Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.<br>* Other names: Visudyne;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subretinal exudation resolution | The percentage of subretinal exudation resolution | 6 months | 
| Percentage of intraretinal exudation resolution | The percentage of intraretinal exudation resolution | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subretinal exudation resolution | Subretinal exudation resolution | 12 months | 
| Percentage of intraretinal exudation resolution | Intraretinal exudation resolution | 12 months | 
| Best corrected visual acuity (BCVA) | Best corrected visual acuity | Baseline | 
| Best corrected visual acuity (BCVA) | Best corrected visual acuity | 12 months | 
| Duration of treatment effect | Duration of treatment effect | Up to 6 months | 
| Foveal thickness | Measured using Optical coherence tomography (OCT) | Baseline | 
| Foveal thickness | Measured using Optical coherence tomography (OCT) | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular degeneration, Lucentis, Triescense, Photodynamic laser treatment