Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy
Reason given: IRB stopped study due to safety concerns before any participants were enrolled.
Key facts
- Where
- Winston-Salem, United StatesSee the site
- Phase
- Phase 4
Where in United States
- Wake Forest Health SciencesWinston-Salem, United StatesNo longer taking part
Trial details
- Who runs it
- Wake Forest University Health Sciences
- Trial code
- NCT04075136
- Record updated
- 22 March 2024
- Original description
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 MonotherapyRead full original descriptionShow less
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
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
Inclusion: 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: Previous treatment with macular photocoagulation, anti-VEGF medication or PDT with Visudyne; Previous vitrectomy; Have received previous treatment for ARMD; Myocardial infarction or cerebrovascular accident within the last 6 weeks; Allergies to fluorescein and indocyanine, dilating agents or anti-VEGF medications; Any uncontrolled condition or illness that in the opinion of the investigator makes the subject unsuitable for the study; Exudation maculopathies without drusen; Optic neuropathy; Diabetic retinopathy; Traction maculopathies.