Neovascular Age-related Macular Degeneration

NCT ID: NCT01712035

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-12-05

Brief Summary

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.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Treatment-naive NVAMD

Individuals who have not received any treatment for neovascular AMD in the study eye

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

David Huang

Steven T. Bailey, MD, Assistant Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU IRB #00008360

Identifier Type: -

Identifier Source: org_study_id