Status:
WITHDRAWN
Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Modulight
Conditions:
Exudative Age Related Macular Degeneration
Eligibility:
All Genders
50-90 years
Phase:
PHASE4
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 Monothe...
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 ca...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04075136
Start Date
March 30 2023
End Date
December 1 2024
Last Update
March 22 2024
Active Locations (1)
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1
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157