Identification and Treatment of Feeder Vessels in Macular Degeneration
Macular Degeneration
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring Age-Related Macular Degeneration, Choroid, Blood Vessels, Choroidal Neovascularization, Laser, Macular Degeneration, AMD
Eligibility Criteria
INCLUSION CRITERIA: To participate in this study, the patient must understand and sign the protocol informed consent. Age greater than or equal to 50 years. In at least one eye, diagnosis of AMD defined by the presence of drusen larger than 63 microm and the presence of choroidal neovascularization under the fovea determined by the Principal Investigator and defined as any one of the following fluorescein angiographic features: Early stippled hyperfluorescence of flat retinal pigment epithelium with ill-defined boundary and little or mild leakage in the late frames of the fluorescein. Irregular elevation of the retinal pigment epithelium that does not exhibit discrete or bright hyperfluorescence in the early transit phase of the angiogram. Stippled hyperfluorescence may be present. Late frames may show persistent fluorescein staining or leakage within a sensory retinal detachment overlying this area. Early well-defined lacy hyperfluorescence with late frames that show persistent fluorescein staining or leakage. Early filling of fluorescein beneath the retinal pigment epithelium with progressive filling during the study and persistent leakage/staining of the space. This may be associated with a "notch" at the borders, areas of more localized leakage at the edge or irregular filling of the area with discrete areas of blockage. Early hyperfluorescence with late frames that shown progressive staining and leakage into surrounding tissue. The eligible eye will be considered the study eye. If both eyes are eligible, the eye with the worse visual acuity will be considered the study eye. Patient must have at least one potential feeder vessels in the study eye identified using Phi-motion ICG. First 5 patients: visual acuity of 20/200 or worse in the study eye. Remaining 15 patients: visual acuity of 20/50 or worse in the study eye. The fellow eye must have visual acuity the same or better than the study eye. Ineligible for a clinically proven laser photocoagulation or photodynamic therapy protocols. Retinal photographs and angiography of sufficient quality allowing assessment of the macular area according to standard clinical practice can be obtained. EXCLUSION CRITERIA: Choroidal neovascularization, in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc. Presence of geographic atrophy under the fovea in the study eye. Decreased vision, in the study eye, due to retinal disease not attributable to CNVM, such as nonexudative forms of ARM, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane. Decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina. History of other antiangiogenic treatment with thalidomide or alpha interferon. Any contraindications to performing the necessary diagnostic studies, especially the use of fluorescein or indocyanine green angiography. Allergy to shellfish, iodine or previous iodine containing dyes. Medical problems that make consistent follow-up over the treatment period unlikely (e.g. stroke, severe MI, terminal carcinoma). Current use of or likely need for systemic or ocular medications known to be toxic to the lens, retina or optic nerve, such as: Deferoxamine Chloroquine/Hydroxychloroquine (Plaquenil) Tamoxifen Phenothiazine Phenothiazines Ethambutol Well-defined choroidal neovascularization (as defined by the MPS) whose area, as seen on the early frames of the SFA, is greater than 50% of the total area of late leakage or staining as determined by the Principal Investigator. Concomitant administration of other experimental therapies for AMD.
Sites / Locations
- National Eye Institute (NEI)