Neovascular Age-related Macular Degeneration
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - 100 |
| Updated: | 4/17/2018 |
| Start Date: | October 2012 |
| End Date: | December 5, 2017 |
OCT Evaluation of Treated and Untreated Choroidal Neovascular Membranes in 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.
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.
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.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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