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Trial record 1 of 6 for:    scott cousins
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Photodynamic Therapy for PDA in NV AMD

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Duke University
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02452840
First received: May 21, 2015
Last updated: November 22, 2016
Last verified: November 2016
  Purpose
The purpose of this prospective observational study is to assess the potential clinical effects of adjunctive verteporfin photodynamic therapy (PDT) for persistent disease activity among patients with neovascular age-related macular degeneration (NV AMD). No specific interventions will occur as part of the study; participating subjects undergoing PDT as part of standard-of-care will be asked to consent to prospective collection of data from their medical records for up to five years from the date of consent, including results from ophthalmologic exams, imaging, and treatments. The primary study outcome will be the percentage of subjects with resolution of persistent disease activity at six months post-PDT treatment. Aside from a small risk of loss of confidentiality, risks associated with this study are no greater than those related to standard of care.

Condition Intervention
Neovascular Age-related Macular Degeneration Macular Degeneration Other: No Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adjunctive Photodynamic Therapy for Persistent Disease Activity in Patients With Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Percentage of subjects with resolution of PDA [ Time Frame: Six months post-PDT treatment ]

Secondary Outcome Measures:
  • Mean change in best-corrected ETDRS visual acuity from baseline [ Time Frame: Six months post-PDT treatment ]
  • Percentage of subjects with 2-line ETDRS visual acuity gain from baseline [ Time Frame: Six months post-PDT treatment ]
  • Percentage of subjects with 2-line ETDRS visual acuity loss from baseline [ Time Frame: Six months post-PDT treatment ]
  • Mean change in central foveal thickness by SD-OCT from baseline [ Time Frame: Six months post-PDT treatment ]
  • Mean change in choroidal neovascularization lesion size by fluorescein angiography from baseline [ Time Frame: Six months post-PDT treatment ]

Estimated Enrollment: 100
Study Start Date: October 2014
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NVAMD Patients with PDA
NVAMD Patients with PDA
Other: No Intervention
No Intervention

Detailed Description:

NV AMD remains the leading cause of vision loss among people over 65. Intravitreal injections with drugs that block vascular endothelial growth factor (VEGF), a major protein mediator of angiogenesis and vascular leakage, have revolutionized treatment of NV AMD. However, less than 40% of treated patients have clinically significant improvement in vision. Further, in spite of continuous monthly anti-VEGF therapy, up to 40-50% of patients demonstrate persistent disease activity (PDA), defined as (1) unresolved intraretinal, subretinal, or sub-retinal pigment epithelium fluid; (2) progressive lesion enlargement and fibrosis; and/or (3) persistent or new hemorrhage, assessed after either loading dose therapy or after sustained treatment with anti-VEGF. Since affected patients are at increased risk for long-term vision loss, PDA remains a vital clinical unmet need.

Verteporfin PDT (Visudyne®, Bausch+Lomb) was approved over 10 years ago by the FDA for treatment of NV AMD, prior to the advent of anti-VEGF therapy. As a monotherapy, PDT is much less effective than anti-VEGF therapy in improving vision for NV AMD patients. Furthermore, in general, PDT in combination with anti-VEGF therapy does not offer benefit over anti-VEGF therapy alone, when assessed among previously treatment-naïve NV AMD patients. However, it is unknown whether adjunctive PDT may be effective for the treatment of PDA. The investigators have performed several retrospective studies of PDA and adjunctive PDT among NV AMD patients in the Duke Medical Retina practice. Preliminary results indicate that moderate to severe PDA occurs in over 40% of NV AMD patients, and that adjunctive verteporfin PDT may be effective in improving PDA and vision for affected patients.

The present study will assess potential clinical benefits of adjunctive PDT for NV AMD patients with PDA in spite of anti-VEGF therapy in a prospective observational clinical case series.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with NVAMD with evidence of PDA in spite of loading dose intravitreal anti-VEGF therapy.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of NV AMD
  • Evidence of PDA in spite of loading dose intravitreal anti-VEGF therapy. PDA is defined as (1) unresolved intraretinal, subretinal, or sub-retinal pigment epithelium fluid; (2) progressive lesion enlargement and fibrosis; and/or (3) persistent or new hemorrhage.
  • Undergoing adjunctive verteporfin PDT for the treatment of PDA
  • Able to give written informed consent

Exclusion Criteria:

  • Prior PDT treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02452840

Contacts
Contact: Scott Cousins, MD 919-684-9010
Contact: Priyatham Mettu, MD 919-684-9010

Locations
United States, North Carolina
Duke Eye Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Ana Garcia-Turner    919-681-8872      
Principal Investigator: Scott Cousins, MD         
Sub-Investigator: Priyatham Mettu, MD         
Sponsors and Collaborators
Duke University
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Scott Cousins, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02452840     History of Changes
Other Study ID Numbers: Pro00057705
Study First Received: May 21, 2015
Last Updated: November 22, 2016

Keywords provided by Duke University:
neovascular age-related macular degeneration
anti-vascular endothelial growth factor
verteporfin
photodynamic therapy
persistent disease activity

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 23, 2017