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

Exudative Age Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04075136
• Other study ID #: IRB00058375
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 30, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Exudative Age Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Ranibizumab
Intravitreal injection 0.5 MG Per 0.05 ML Injection.

Device:
• Photodynamic 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.

Drug:
• Triamcinolone Acetonide
Intravitreal injection of 0.5ml-2mg
• verteporfin
Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Modulight

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subretinal exudation resolution	The percentage of subretinal exudation resolution	6 months
Primary	Percentage of intraretinal exudation resolution	The percentage of intraretinal exudation resolution	6 months
Secondary	Percentage of subretinal exudation resolution	Subretinal exudation resolution	12 months
Secondary	Percentage of intraretinal exudation resolution	Intraretinal exudation resolution	12 months
Secondary	Best corrected visual acuity (BCVA)	Best corrected visual acuity	Baseline
Secondary	Best corrected visual acuity (BCVA)	Best corrected visual acuity	12 months
Secondary	Duration of treatment effect	Duration of treatment effect	Up to 6 months
Secondary	Foveal thickness	Measured using Optical coherence tomography (OCT)	Baseline
Secondary	Foveal thickness	Measured using Optical coherence tomography (OCT)	12 Months