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

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status and phase

Withdrawn
Phase 4

Conditions

Exudative Age Related Macular Degeneration

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04075136
IRB00058375

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

50 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 3 patient groups

Arm A: Lucentis
Active Comparator group
Description:
A standard of care treatment of 0.05ml/0.5mg Lucentis given every 4 weeks for 48 weeks.
Treatment:
Drug: Ranibizumab
Arm B: Lucentis & PDT Laser
Experimental group
Description:
A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence.
Treatment:
Drug: Ranibizumab
Drug: verteporfin
Device: Photodynamic laser treatment (PDT)
Arm C: Lucentis, PDT Laser and Triescense
Experimental group
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.
Treatment:
Drug: Ranibizumab
Drug: Triamcinolone Acetonide
Drug: verteporfin
Device: Photodynamic laser treatment (PDT)

Trial contacts and locations

1

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Central trial contact

Angela Mitchell; Mark Nelson, MD

Data sourced from clinicaltrials.gov

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