Neovascular Age-related Macular Degeneration (NVAMD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01712035
First received: October 19, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

Age-related macular degeneration (AMD) is the leading cause of blindness in non-Hispanic white Americans. Neovascular AMD is an advanced form of macular degeneration that historically has accounted for the majority of vision loss related to AMD. The presence of choroidal neovascular membrane (CNV) formation is the hallmark feature of neovascular AMD. Choroidal neovascular membranes consist of buds of neovascular tissue and accompanying fibroblasts from the choroid perforating Bruch's membrane with extension either above or below the retinal pigment epithelium. These neovascular complexes are associated with hemorrhage, fluid exudation and fibrosis formation resulting in photoreceptor damage and vision loss. Treatment of neovascular AMD consists of injecting inhibitors of vascular endothelial growth factor (VEGF) into the vitreous cavity to interfere with proliferation of choroidal neovascularization and to reduce vascular permeability.

OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging, except that OCT measures the intensity of reflected light rather than acoustical waves.

This observational study will use OCT technology to study and compare the retinal and choroidal anatomy and blood flow in two groups of patients with neovascular AMD: treatment naïve group and active treatment group.

The purpose of this study is to assess the utility of OCT angiography in the evaluation of NVAMD.


Condition
Neovascular Age-related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: OCT Evaluation of Treated and Untreated Choroidal Neovascular Membranes in Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Number of patients with NVAMD receiving treatment who also have changed retinal/choroidal anatomy and/or blood flow compared to treatment naive NVAMD patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Treatment-active NVAMD
Patients with NVAMD who have received treatment with an anti-VEGF agent (Avastin, Lucentis, Macugen, or Eylea) 6 weeks prior enrollment visit
Treatment-naive NVAMD
Individuals who have not received any treatment for neovascular AMD in the study eye

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults older than age 50 with clinical findings of neovascular AMD with clinical evidence of active choroidal neovascular membrane

Criteria

Inclusion Criteria:

  • Presence of Neovascular AMD confirmed by fluorescein dye leakage on angiogram or presence of at least one of the following on OCT: subretinal fluid, intraretinal fluid, or sub-retinal pigment epithelial fluid.
  • Treatment naïve group consists of individuals who have not received any treatment for neovascular AMD in the study eye
  • Active treatment group consists of individuals who have received treatment with an anti-VEGF agent (Avastin, Lucentis, Macugen, or Eylea) 6 weeks prior enrollment visit

Exclusion Criteria:

  • Inability to give informed consent.
  • Inability to maintain stable fixation for OCT imaging
  • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  • A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  • Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
  • Women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography.
  • Unable to ambulate and take tram from clinic to where OCT is located
  • Prior macular laser treatment
  • Subretinal hemorrhage or fibrosis >50% of choroidal neovascular lesion
  • Visual acuity 20/200 or worse
  • An ocular condition is present such that, in the opinion of the investigator, may alter the retinal anatomy (eg: epiretinal membrane)
  • An ocular condition is present (other than Neovascular AMD) that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, etc.).
  • Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
  • History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months.
  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: NCT01712035

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Ann Lundquist    503-494-3000      
Contact: Mitchell Schain    503-494-3000      
Principal Investigator: Steven Bailey, MD         
Sponsors and Collaborators
Oregon Health and Science University
  More Information

No publications provided

Responsible Party: David Huang, Steven T. Bailey, MD, Assistant Professor of Ophthalmology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01712035     History of Changes
Other Study ID Numbers: OHSU IRB #00008360
Study First Received: October 19, 2012
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Wet AMD
Age-related macular degeneration
Optical coherenece tomography
Imaging
Blood flow

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

ClinicalTrials.gov processed this record on July 22, 2014