Triamcinolone Acetonide Plus Laser Therapy to Treat Age-Related Macular Degeneration

Age-related macular degeneration (AMD) represents the most common cause of blindness in persons over the age of 50. 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 neovascularization portending 4 disc areas or less or all lesions with predominately classic composition (lesions having at least 50% of vessels which can be readily demarcated with fluorescein angiography) can benefit from treatment with photodynamic therapy (verteporfin - PDT). However, this treatment only results in a reduction in the number of participants who suffer moderate and severe vision loss. Few participants demonstrate an improvement in visual acuity. Histopathologic studies have demonstrated the presence of an inflammatory response in the retina and choroid of participants with choroidal neovascularization as well as in eyes receiving verteporfin - PDT. Therefore, the use of triamcinolone acetonide, which possesses anti-inflammatory as well as anti-angiogenic properties, may be beneficial in participants with neovascular AMD undergoing verteporfin - PDT. This study will be organized as a controlled, participant masked, randomized, multi-center Phase II/III study that will investigate the efficacy of a preservative - free intravitreal formulation of triamcinolone acetonide (TAC-PF) in AMD participants undergoing verteporfin - PDT. Unlike studies that use steroids containing benzyl alcohol, this study will evaluate preservative-free steroids. Three hundred participants with neovascular AMD, undergoing verteporfin - PDT, will be randomly assigned to receive either a sham intravitreal injection, a 1 mg intravitreal injection of TAC-PF, or a 4 mg intravitreal injection of TAC-PF. Depending on a participant's response, treatments as randomized, may be repeated at 3-month intervals. Participants will complete a maximum of 2 years of follow-up. The primary efficacy outcome measure is the proportion of participants who experience a moderate vision loss defined as a drop of greater than or equal to 15 letters in best-corrected visual acuity from baseline verteporfin - PDT treatment to month 12. Secondary outcomes will include assessments of the safety of the adjunct therapy; additional vision changes observed between baseline, month 3, month 12, and month 24; lesion changes observed between baseline, month 3, month 12 and month 24; and changes observed in lens opacities between baseline, month 12, and month 24.