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

Wake Forest University (WFU)

Status and phase: Withdrawn; Phase 4

Conditions: Exudative Age Related Macular Degeneration

Treatments: Device: Photodynamic laser treatment (PDT); Drug: verteporfin; Drug: Triamcinolone Acetonide; Drug: Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04075136

IRB00058375

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Arm A: Lucentis

Active Comparator group

Description:

A standard of care treatment of 0.05ml/0.5mg Lucentis given every 4 weeks for 48 weeks.

Treatment:

Drug: Ranibizumab

Arm B: Lucentis & PDT Laser

Experimental group

Description:

A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence.

Treatment:

Drug: Ranibizumab

Drug: verteporfin

Device: Photodynamic laser treatment (PDT)

Arm C: Lucentis, PDT Laser and Triescense

Experimental group

Description:

A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence and an intravitreal injection of 0.5ml-2mg Triescence at the time of PDT treatment.

Treatment:

Drug: Ranibizumab

Drug: Triamcinolone Acetonide

Drug: verteporfin

Device: Photodynamic laser treatment (PDT)