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

NCT04075136 | Withdrawn Phase 4 FDA Drug FDA Device

• 1 other identifier: IRB00058375
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Exudative Age Related Macular Degeneration

Keywords

Macular degeneration; Lucentis; Triescense; Photodynamic laser treatment

Outcome Measures

Primary Outcomes (2)

• Percentage of subretinal exudation resolution

  The percentage of subretinal exudation resolution

  6 months

• Percentage of intraretinal exudation resolution

  The percentage of intraretinal exudation resolution

  6 months

Secondary Outcomes (7)

• Percentage of subretinal exudation resolution

  12 months

• Percentage of intraretinal exudation resolution

  12 months

• Best corrected visual acuity (BCVA)

  Baseline

• Best corrected visual acuity (BCVA)

  12 months

• Duration of treatment effect

  Up to 6 months

Study Arms (3)

Arm A: Lucentis

ACTIVE COMPARATOR

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

Drug: Ranibizumab

Arm B: Lucentis & PDT Laser

EXPERIMENTAL

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

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

Arm C: Lucentis, PDT Laser and Triescense

EXPERIMENTAL

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.

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

Interventions

Ranibizumab DRUG

Intravitreal injection 0.5 MG Per 0.05 ML Injection.

Also known as: Lucentis

Arm A: Lucentis; Arm B: Lucentis & PDT Laser; Arm C: Lucentis, PDT Laser and Triescense

Photodynamic laser treatment (PDT) 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.

Arm B: Lucentis & PDT Laser; Arm C: Lucentis, PDT Laser and Triescense

Triamcinolone Acetonide DRUG

Intravitreal injection of 0.5ml-2mg

Also known as: Triesence

Arm C: Lucentis, PDT Laser and Triescense

verteporfin DRUG

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

Also known as: Visudyne

Arm B: Lucentis & PDT Laser; Arm C: Lucentis, PDT Laser and Triescense

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Modulight: collaborator

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab; Triamcinolone Acetonide; Triamcinolone; Verteporfin

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds

Study Officials

• Mark Nelson, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: August 30, 2019
• Study Start: March 30, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 22, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)