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

Primary Purpose

Exudative Age Related Macular Degeneration

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Photodynamic laser treatment (PDT)
Triamcinolone Acetonide
verteporfin
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Age Related Macular Degeneration focused on measuring Macular degeneration, Lucentis, Triescense, Photodynamic laser treatment

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Wake Forest Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Arm A: Lucentis

Arm B: Lucentis & PDT Laser

Arm C: Lucentis, PDT Laser and Triescense

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Percentage of subretinal exudation resolution
The percentage of subretinal exudation resolution
Percentage of intraretinal exudation resolution
The percentage of intraretinal exudation resolution

Secondary Outcome Measures

Percentage of subretinal exudation resolution
Subretinal exudation resolution
Percentage of intraretinal exudation resolution
Intraretinal exudation resolution
Best corrected visual acuity (BCVA)
Best corrected visual acuity
Best corrected visual acuity (BCVA)
Best corrected visual acuity
Duration of treatment effect
Duration of treatment effect
Foveal thickness
Measured using Optical coherence tomography (OCT)
Foveal thickness
Measured using Optical coherence tomography (OCT)

Full Information

First Posted
August 29, 2019
Last Updated
April 28, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Modulight
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1. Study Identification

Unique Protocol Identification Number
NCT04075136
Brief Title
Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Modulight

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age Related Macular Degeneration
Keywords
Macular degeneration, Lucentis, Triescense, Photodynamic laser treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Lucentis
Arm Type
Active Comparator
Arm Description
A standard of care treatment of 0.05ml/0.5mg Lucentis given every 4 weeks for 48 weeks.
Arm Title
Arm B: Lucentis & PDT Laser
Arm Type
Experimental
Arm Description
A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence.
Arm Title
Arm C: Lucentis, PDT Laser and Triescense
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Intravitreal injection 0.5 MG Per 0.05 ML Injection.
Intervention Type
Device
Intervention Name(s)
Photodynamic laser treatment (PDT)
Intervention Description
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
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Triesence
Intervention Description
Intravitreal injection of 0.5ml-2mg
Intervention Type
Drug
Intervention Name(s)
verteporfin
Other Intervention Name(s)
Visudyne
Intervention Description
Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.
Primary Outcome Measure Information:
Title
Percentage of subretinal exudation resolution
Description
The percentage of subretinal exudation resolution
Time Frame
6 months
Title
Percentage of intraretinal exudation resolution
Description
The percentage of intraretinal exudation resolution
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of subretinal exudation resolution
Description
Subretinal exudation resolution
Time Frame
12 months
Title
Percentage of intraretinal exudation resolution
Description
Intraretinal exudation resolution
Time Frame
12 months
Title
Best corrected visual acuity (BCVA)
Description
Best corrected visual acuity
Time Frame
Baseline
Title
Best corrected visual acuity (BCVA)
Description
Best corrected visual acuity
Time Frame
12 months
Title
Duration of treatment effect
Description
Duration of treatment effect
Time Frame
Up to 6 months
Title
Foveal thickness
Description
Measured using Optical coherence tomography (OCT)
Time Frame
Baseline
Title
Foveal thickness
Description
Measured using Optical coherence tomography (OCT)
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Mitchell
Phone
336-713-1680
Email
angmitch@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Nelson, MD
Phone
336-713-1680
Email
mhnelson@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Nelson, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Nelson, MD
Phone
336-713-1680
Email
mhnelson@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Mark Nelson, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will updated once final analysis is complete.

Learn more about this trial

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

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