Exudative Age Related Macular Degeneration
Conditions
Keywords
Macular degeneration, Lucentis, Triescense, Photodynamic laser treatment
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.
Interventions
DRUGRanibizumab
Intravitreal injection 0.5 MG Per 0.05 ML Injection.
DEVICEPhotodynamic laser treatment (PDT)
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.
DRUGTriamcinolone Acetonide
Intravitreal injection of 0.5ml-2mg
DRUGverteporfin
Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.
Sponsors
Modulight
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity (BCVA) | Baseline | Best corrected visual acuity |
| Percentage of subretinal exudation resolution | 12 months | Subretinal exudation resolution |
| Foveal thickness | Baseline | Measured using Optical coherence tomography (OCT) |
| Duration of treatment effect | Up to 6 months | Duration of treatment effect |
| Percentage of intraretinal exudation resolution | 12 months | Intraretinal exudation resolution |
Countries
United States
Outcome results
None listed