Neovascular Age-related Macular Degeneration

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

OCT Evaluation of Treated and Untreated Choroidal Neovascular Membranes in Age-Related Macular Degeneration

Acronym: NVAMD

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Oct 23, 2012
Registry last updated: Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed