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Trial record 2 of 6 for:    scott cousins

Neovascular Morphology and Persistent Disease Activity Among Patients With NV AMD

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02367365
First received: February 13, 2015
Last updated: January 25, 2017
Last verified: November 2016
  Purpose
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 have revolutionized treatment of NV AMD. However, less than 40% of treated patients have clinically significant imporovement in vision. In this study, we will determine the relative frequency of neovascular subtypes in two groups: 1) a representative, treatment-naive NV AMD patient population, and 2) a population of patients who develop recurrent NV AMD activity while off treatment and assess the frequency of persistent disease activity (PDA) according to specific neovascular morphologic subtypes. This information will clarify the scope of the PDA problem and will identify patients with PDA who may benefit from additional therpeutic strategies.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neovascular Morphology and Persistent Disease Activity Among Patients With Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Frequency of ICG neovascular subtypes [ Time Frame: 4-6 weeks post loading dose ]
  • Percentage of each neovascular subtype exhibiting persistent disease activity [ Time Frame: 4-6 weeks post loading dose ]

Enrollment: 75
Study Start Date: December 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment Naive NVAMD Patients
Patients with treatment naive NVAMD diagnosed in the last three months
Other: No Intervention
No intervention
Newly Reactivated NVAMD Patients
Patients with newly reactivated NVAMD which has been previously quiescent off treatment
Other: No Intervention
No intervention

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.

  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 treatment naive NVAMD or newly reactivated NVAMD
Criteria

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
  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: NCT02367365

Locations
United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27710
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: NCT02367365     History of Changes
Other Study ID Numbers: Pro00055232
Study First Received: February 13, 2015
Last Updated: January 25, 2017

Keywords provided by Duke University:
Neovascular Age-Related Macular Degeneration
anti-vascular endothelial growth factor
neovascular lesion morphology
indocyanine green angiography
persistent disease activity

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

ClinicalTrials.gov processed this record on May 22, 2017