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

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Ranibizumab; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide; Verteporfin

Criteria

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