Age-related macular degeneration (AMD) represents the most common cause of blindness in patients over the age of 60. The major cause of vision loss in this disease is due to the development of choroidal neovascularization. Several clinical trials have shown that eyes with predominately """"""""well-defined"""""""" areas of neovascularization (lesions having at least 50% of vessels which can be readily demarcated with fluorescein angiography) can benefit from treatment with photodynamic therapy (PDT). However, this treatment benefit only results in a reduction in the number of patients who suffer severe vision loss. Few patients demonstrate an improvement in visual acuity. In addition, other neovascular lesions such as those with predominate occult (vessels that are difficult to outline by fluorescein angiograhy) or pure occult do not demonstrate any substantial treatment benefit. Histopathologic studies have demonstrated the presence of an inflammatory response in the retina of patients with choroidal neovascularization as well as in eyes receiving PDT. In addition, in eyes receiving PDT, a vascular remodeling and continued neovascular process occurs. Therefore, the use of celecoxib (Celebrex?), a specific cyclooxygenase-2 inhibitor, which possesses both anti-angiogenic as well as anti-inflammatory properties, may be beneficial in patients with neovascular AMD undergoing PDT. The study is organized as a double-masked, randomized, placebo-controlled, prospective multi-center clinical trial to investigate the ability of celecoxib to alter the inflammatory and neovascular responses in AMD patients undergoing PDT. The results of this study will contribute to the design of a larger definitive clinical trial. The primary outcome measure is a drop of 15 letters or more in best corrected visual acuity following initial PDT treatment at 1 year. The secondary outcome measures are stabilization (drop of 4 letters or less from baseline) or improvement of best corrected visual acuity following initial PDT treatment at week 36, and an improvement by 5 or more letters in visual acuity from baseline to week 36, time to retreatment with PDT, number of retreatments with PDT, a change in the CNV size, the extent of leakage, and staining detected by fluorescein angiography. Additional outcome measures will be the change in size and extent of vascular remodeling and choroidal new vessel formation as determined by optical coherence tomography (OCT) and high-speed indocyanine green angiography (HS-ICG). To date, all 60 patients required for the study have been enrolled and the one year follow-up period is on-going.
