Neovascular Age-related Macular DegenerationNCT02452840
Photodynamic Therapy for PDA in NV AMD
An observational study of Neovascular Age-related Macular Degeneration and Macular Degeneration, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Macular Degeneration
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2015to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NVAMD with evidence of PDA in spite of loading dose intravitreal anti-VEGF therapy.
Who may be able to join
- 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
Who cannot join
- Prior PDT treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- No Intervention
- Keywords
- neovascular age-related macular degeneration, anti-vascular endothelial growth factor, verteporfin, photodynamic therapy, persistent disease activity
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| NVAMD Patients with PDA | NVAMD Patients with PDA Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with resolution of PDA
Measured: Six months post-PDT treatment
Secondary outcomes (5)
Mean change in best-corrected ETDRS visual acuity from baseline
Measured: Six months post-PDT treatment
Percentage of subjects with 2-line ETDRS visual acuity gain from baseline
Measured: Six months post-PDT treatment
Percentage of subjects with 2-line ETDRS visual acuity loss from baseline
Measured: Six months post-PDT treatment
Mean change in central foveal thickness by SD-OCT from baseline
Measured: Six months post-PDT treatment
Mean change in choroidal neovascularization lesion size by fluorescein angiography from baseline
Measured: Six months post-PDT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study start11 May 2015
- Primary completionFeb 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
- Investigators
- Scott Cousins, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452840
- Sponsor's protocol ID
- Pro00057705
- Status last verified
- Nov 2021
- First submitted
- 21 May 2015
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Photodynamic Therapy for Persistent Disease Activity in Patients With Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02452840
- Acronym / sponsor ID
- Pro00057705
- Keywords
- neovascular age-related macular degeneration, anti-vascular endothelial growth factor, verteporfin, photodynamic therapy, persistent disease activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- 11 May 2015 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NVAMD Patients with PDA | – | Other: No InterventionNVAMD Patients with PDA |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NVAMD with evidence of PDA in spite of loading dose intravitreal anti-VEGF therapy.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Prior PDT treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | NVAMD Patients with PDA |
Primary outcome
Percentage of subjects with resolution of PDA
Time frame: Six months post-PDT treatment
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Cousins, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration and Macular Degeneration, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with resolution of PDA (time frame: Six months post-PDT treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021; AzTrials last refreshed its copy on 31 Oct 2026.