Photodynamic Therapy for PDA in NV AMD
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 7/20/2018 |
| Start Date: | October 2014 |
| End Date: | October 2022 |
| Contact: | Scott Cousins, MD |
| Phone: | 919-684-9010 |
Adjunctive Photodynamic Therapy for Persistent Disease Activity in Patients With Neovascular Age-Related Macular Degeneration
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.
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.
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.
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.
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
We found this trial at
1
site
Durham, North Carolina 27710
Principal Investigator: Scott Cousins, MD
Phone: 919-681-8872
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