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

March 20, 2024 updated by: Wake Forest University Health Sciences

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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: 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
Drug: Triamcinolone Acetonide
Intravitreal injection of 0.5ml-2mg
Other Names:
  • Triesence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subretinal exudation resolution
Time Frame: 6 months
The percentage of subretinal exudation resolution
6 months
Percentage of intraretinal exudation resolution
Time Frame: 6 months
The percentage of intraretinal exudation resolution
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subretinal exudation resolution
Time Frame: 12 months
Subretinal exudation resolution
12 months
Percentage of intraretinal exudation resolution
Time Frame: 12 months
Intraretinal exudation resolution
12 months
Best corrected visual acuity (BCVA)
Time Frame: Baseline
Best corrected visual acuity
Baseline
Best corrected visual acuity (BCVA)
Time Frame: 12 months
Best corrected visual acuity
12 months
Duration of treatment effect
Time Frame: Up to 6 months
Duration of treatment effect
Up to 6 months
Foveal thickness
Time Frame: Baseline
Measured using Optical coherence tomography (OCT)
Baseline
Foveal thickness
Time Frame: 12 Months
Measured using Optical coherence tomography (OCT)
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Modulight

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 29, 2019

First Submitted That Met QC Criteria

August 29, 2019

First Posted (Actual)

August 30, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00058375

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results will updated once final analysis is complete.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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