Celecoxib to Treat Macular Degeneration in Patients Receiving Photodynamic Therapy

INCLUSION CRITERIA: To participate in this study, the study participant 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 micro milli. The presence of choroidal neovascularization under the fovea determined by the Principal Investigator of each clinical site and defined as any one of the following fluorescein angiographic (FA) 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 (occult). 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 (occult). Late phase leakage of undetermined source with leakage at the level of the retinal pigment epithelium in the late-frames of the angiogram in which the source of the late leakage cannot be determined from earlier-phase frames of the angiogram (occult). A well-demarcated area of bright hyperfluorescence in the early phase of the angiograpm with leakage through the mid- and late- phase frames which obscures the boundaries of the area (classic). The greatest linear dimension of the entire lesion (classic CNV, occult CNV and any features that could obscure the identification of classic or occult CNV has to be less than or equal to 5400 micro milli in greatest linear dimension on the retina as measured by the treating ophthalmologist. If the lesion is designated as entirely occult, then additionally, the greatest linear dimension of the lesion must be greater than 525 micro milli (total area of 1/2 disc area). Additionally, if the lesion is designated as entirely occult then there should be 'presumed recent disease progression' that may include the presence of blood from CNV, growth of the lesion (at least 10% increase in the greatest linear dimension) or deterioration inVA (a one line loss) within the preceding 12 weeks. Visual acuity of 20/40 - 20/200 (66 - 34 letters) as measured on an ETDRS chart. If both eyes are eligible then the eye with the worst visual acuity will be treated and considered the study eye. 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, the study eye, due to retinal disease not attributable to CNV, 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 of concomitant administration of other experimental therapies for AMD other than nonfoveal confluent laser photocoagulation. Presence of fibrosis, hemorrhage, pigment epithelial detachments, tear (rip) of the retinal pigment epithelium or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion. Prior PDT treatment in the study eye. Any contraindications to performing the necessary diagnostic studies, especially the use of fluorescein or indocyanine green angiography. Allergy to iodine or previous iodine containing dyes. Allergy to eggs. Porphyria or other porphyrin sensitivity. 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 know to be toxic to the lens, retina or optic nerve, such as: Deferoxamine Chloroquine/Hydroxychloroquine (Plaquenil) Tamoxifen Phenothiazine Phenothiazines Ethambutol History of intra-cranial bleeds. Positive urine pregnancy test or currently lactating for women of childbearing potential. Current history of malignancy (except study participants having a basal cell carcinoma that was treated successfully, or other malignancy operated on and in remission for 5 years prior to inclusion in the trial). Use of tetracycline or doxycycline. Intraocular surgery within the last 2 months or capsulotomy within the last month in the study eye. Use of any investigational drug within 30 days of enrollment. Laboratory values outside normal limits and considered clinically significant by the investigator. Malabsorption syndrome. Celebrex, any other COX-2 inhibitor, NSAID, or ocular topical NSAID use greater than 3 days per week for a period of greater than or equal to 4 weeks within 2 weeks prior to enrollment of likely need during the study. Aspirin greater than 81 mg/day is permitted up to 1 week prior to enrollment and daily aspirin use of no more than 81 mg/day during the study is permitted. Allergy to sulpha-containing compounds, NSAIDs, or demonstration o the aspiring triad. History of kidney disease (creatinine level greater than 2.5 dL, need for dialysis, or microalbuminurea). Liver disease. Concurrent use of warfarinor known bleeding diathesis. History of inflammatory bowel disease. Concurrent use of lithium. History of peptic ulcer within 1 year prior to enrollment. History of myocardial infarction 2 years prior to enrollment.