- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02367365
Neovascular Morphology and Persistent Disease Activity Among Patients With NV AMD
Neovascular Morphology and Persistent Disease Activity Among Patients With Neovascular Age-Related Macular Degeneration
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neovascular Age-Related Macular Degeneration (NV AMD) remains the leading cause of vision loss among people over 65. Intravitreal injections with drugs that block 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 sustained 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.
We are interested in the relationship between NV lesion morphology and response to therapy. Specifically, we hypothesize that specific NV morphologic subtypes are more frequently associated with PDA, based on preliminary retrospective analyses of indocyanine green (ICG) imaging data from NV AMD patients in our Duke Medical Retina practice. We have observed that eyes with Capillary pattern, seen as a discrete homogenous focus of microvessels, are highly responsive to anti-VEGF therapy and rarely exhibit PDA (<20% of cases). In contrast, eyes with Arteriolar pattern (large-caliber feeding artery, many branching arterioles, and minimal capillary component) and eyes with polypoidal choroidal vasculopathy (variably sized and numbered, discrete saccular dilations of choroidal vasculature), demonstrate PDA in up to 70% of cases. A third subtype, choroidal leak syndrome, visible as choroidal hyperpermeability and leakage, manifest PDA in over 60% of cases. These data suggest that complex NV lesion morphology is the primary cause of PDA, and that anti-VEGF therapy alone is insufficient for these patients. However, the relative frequency of these subtypes and the association of PDA and NV lesion morphology, in a treatment-naive population free of selection bias, are unknown.
In this study, we will determine the relative frequency of NV subtypes in two groups: (i) a representative, treatment-naïve NV AMD patient population, and (ii) a population of patients who develop recurrent NVAMD activity while off treatment and assess the frequency of PDA according to specific NV morphologic subtypes. This information will clarify the scope of the PDA problem, and will identify patients with PDA who may benefit from additional therapeutic strategies.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Eye Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of either treatment naive NVAMD or newly reactivated NVAMD which has been previously quiescent off treatment
- Men and women aged 50 years or older
- Able to provide written informed consent
Exclusion Criteria:
- Potential study eye with ongoing (within previous 6 months of diagnosis of NVAMD disease activity) treatment for CNV, including anti-VEGF medications, corticosteroids, photodynamic therapy, thermal laser photocoagulation, transpupillary thermotherapy, or pneumatic displacement of macular hemorrhage
- CNV secondary to causes other than AMD
- Known or suspected sensitivity or allergy to ICG dye
- Known or suspected sensitivity or allergy to fluorescein dye
- Significant medial opacity (e.g. cataract) precluding clincial imaging adequate for interpretation
- Prior history of vitrectomy surger in potential study eye
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Treatment Naive NVAMD Patients
Patients with treatment naive NVAMD diagnosed in the last three months
|
No intervention
|
Newly Reactivated NVAMD Patients
Patients with newly reactivated NVAMD which has been previously quiescent off treatment
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of ICG neovascular subtypes
Time Frame: 4-6 weeks post loading dose
|
4-6 weeks post loading dose
|
Percentage of each neovascular subtype exhibiting persistent disease activity
Time Frame: 4-6 weeks post loading dose
|
4-6 weeks post loading dose
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott Cousins, MD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00055232
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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