Photodynamic Therapy for PDA in NV AMD
Adjunctive Photodynamic Therapy for Persistent Disease Activity in Patients With Neovascular Age-Related Macular Degeneration
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2015
CompletedFirst Submitted
Initial submission to the registry
May 21, 2015
CompletedFirst Posted
Study publicly available on registry
May 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedNovember 9, 2021
November 1, 2021
3.7 years
May 21, 2015
November 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of subjects with resolution of PDA
Six months post-PDT treatment
Secondary Outcomes (5)
Mean change in best-corrected ETDRS visual acuity from baseline
Six months post-PDT treatment
Percentage of subjects with 2-line ETDRS visual acuity gain from baseline
Six months post-PDT treatment
Percentage of subjects with 2-line ETDRS visual acuity loss from baseline
Six months post-PDT treatment
Mean change in central foveal thickness by SD-OCT from baseline
Six months post-PDT treatment
Mean change in choroidal neovascularization lesion size by fluorescein angiography from baseline
Six months post-PDT treatment
Study Arms (1)
NVAMD Patients with PDA
NVAMD Patients with PDA
Interventions
Eligibility Criteria
Patients with NVAMD with evidence of PDA in spite of loading dose intravitreal anti-VEGF therapy.
You may qualify if:
- 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
You may not qualify if:
- Prior PDT treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Bausch & Lomb Incorporatedcollaborator
Study Sites (1)
Duke Eye Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Cousins, MD
Duke University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2015
First Posted
May 25, 2015
Study Start
May 11, 2015
Primary Completion
February 1, 2019
Study Completion
August 1, 2019
Last Updated
November 9, 2021
Record last verified: 2021-11