Clinical trial NCT04075136: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Exudative Age Related Macular Degeneration
Keywords: Macular degeneration
Lucentis
Triescense
Photodynamic laser treatment
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Modulight
First posted: 2019-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of subretinal exudation resolution
timeFrame: 6 months
measure: Percentage of intraretinal exudation resolution
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of subretinal exudation resolution
timeFrame: 12 months
measure: Percentage of intraretinal exudation resolution
timeFrame: 12 months
measure: Best corrected visual acuity (BCVA)
timeFrame: Baseline
measure: Best corrected visual acuity (BCVA)
timeFrame: 12 months
measure: Duration of treatment effect
timeFrame: Up to 6 months
measure: Foveal thickness
timeFrame: Baseline
measure: Foveal thickness
timeFrame: 12 Months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mark Nelson, MD
role: PRINCIPAL_INVESTIGATOR
References: