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

Last updated: March 20, 2024
Sponsor: Wake Forest University Health Sciences
Overall Status: Trial Not Available

Phase

4

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Ranibizumab

verteporfin

Triamcinolone Acetonide

Clinical Study ID

NCT04075136
IRB00058375
  • Ages 50-90
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 angiogramand optical coherent tomography angiography
  • Visual Acuity of 20/25 to 20/400 at screening and baseline visits using anautorefractor 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 methodsof birth control.

Exclusion

Exclusion Criteria:

  • Exudation maculopathies without drusen
  • Previous treatment with macular photocoagulation, anti-VEGF medication or PDT withVisudyne
  • 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 makesthe subject unsuitable for the study

Study Design

Treatment Group(s): 4
Primary Treatment: Ranibizumab
Phase: 4
Study Start date:
March 30, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Wake Forest Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

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