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

NCT ID: NCT04075136

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2024-12-31

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 Monotherapy

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 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.

Conditions

Exudative Age Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm A: Lucentis

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

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

Intravitreal injection 0.5 MG Per 0.05 ML Injection.

Arm B: Lucentis & PDT Laser

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

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: DRUG

Intravitreal injection 0.5 MG Per 0.05 ML Injection.

Photodynamic laser treatment (PDT)

Intervention Type: DEVICE

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.

verteporfin

Intervention Type: DRUG

Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.

Arm C: Lucentis, PDT Laser and Triescense

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.

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: DRUG

Intravitreal injection 0.5 MG Per 0.05 ML Injection.

Photodynamic laser treatment (PDT)

Intervention Type: DEVICE

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.

Triamcinolone Acetonide

Intervention Type: DRUG

Intravitreal injection of 0.5ml-2mg

verteporfin

Intervention Type: DRUG

Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.

Interventions

Ranibizumab

Intravitreal injection 0.5 MG Per 0.05 ML Injection.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Triamcinolone Acetonide

Intravitreal injection of 0.5ml-2mg

Intervention Type: DRUG

verteporfin

Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.

Intervention Type: DRUG

Other Intervention Names

Lucentis; Triesence; Visudyne

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Modulight

UNKNOWN

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Nelson, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00058375

Identifier Type: -

Identifier Source: org_study_id