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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04075136
Collaborator
Modulight (Other)
150
Enrollment
1
Location
3
Arms
13
Anticipated Duration (Months)
11.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A: Lucentis

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

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

    		•
    Experimental: Arm B: Lucentis & PDT Laser

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

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

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

    		•
    Experimental: 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.

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

    • 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
    Other Names:
  • Triesence

    • Drug: verteporfin
    Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.
    Other Names:
  • Visudyne

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of subretinal exudation resolution [6 months]

      The percentage of subretinal exudation resolution

    2. Percentage of intraretinal exudation resolution [6 months]

      The percentage of intraretinal exudation resolution

    Secondary Outcome Measures

    1. Percentage of subretinal exudation resolution [12 months]

      Subretinal exudation resolution

    2. Percentage of intraretinal exudation resolution [12 months]

      Intraretinal exudation resolution

    3. Best corrected visual acuity (BCVA) [Baseline]

      Best corrected visual acuity

    4. Best corrected visual acuity (BCVA) [12 months]

      Best corrected visual acuity

    5. Duration of treatment effect [Up to 6 months]

      Duration of treatment effect

    6. Foveal thickness [Baseline]

      Measured using Optical coherence tomography (OCT)

    7. Foveal thickness [12 Months]

      Measured using Optical coherence tomography (OCT)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • Modulight

    Investigators

    • Principal Investigator: Mark Nelson, MD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04075136
    Other Study ID Numbers:
    • IRB00058375
    First Posted:
    Aug 30, 2019
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Wake Forest University Health Sciences
    Macular degeneration
    Lucentis
    Triescense
    Photodynamic laser treatment
    Additional relevant MeSH terms:
    Macular Degeneration
    Wet Macular Degeneration
    Triamcinolone
    Triamcinolone Acetonide
    Triamcinolone hexacetonide
    Ranibizumab
    Verteporfin
    Triamcinolone diacetate

    Study Results

    No Results Posted as of Aug 24, 2022