Conditions: Age Related Macular Degeneration
Keywords: AMD Almera Steroid Macular ARMD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6
Healthy volunteers: no

Brief summary:
Treatment of exudative age-related macular degeneration has been significantly improved by the advent of Lucentis™( which provides improved vision rather than simply stabilization) is common; however, monthly injections may be required to maintain this effect. It is hypothesized that sustained release fluocinolone acetonide will allow maintenance of the improved vision with fewer Lucentis injections.

Detailed description:
Treatment of exudative age-related macular degeneration has been significantly improved by the advent of Lucentis™( which provides improved vision rather than simply stabilization) is common; however, monthly injections may be required to maintain this effect. The use of the glucocorticoids such as triamcinolone acetonide as adjunct treatment for exudative age-related macular degeneration has been reported to enhance the efficacy of photodynamic therapy with Visudyne® (verteporphin for injection). It is hypothesized that sustained release fluocinolone acetonide will allow maintenance of the improved vision with fewer Lucentis injections. This study is a pilot phase 2b study to test this hypothesis. The safety assessments will continue through 36 months.This study will compare the safety 2 doses of FA/Medidur in conjunction with Lucentis (as needed) in patients with neovascular AMD who have have been treated with Lucentis for at least 6 months and have reached a plateau.

Arms:
arm 1: Dose 0.2 ug/day Medidur implant arm 2: Dose 0.5 ug/day Medidur implant

Interventions: intervention 1: Fluocinolone Acetonide/Medidur intervention 2: Fluocinolone Acetonide/Medidur
Intervention descriptions: intervention 1: 0.2 ug/day implant intervention 2: 0.5 ug/day implant

Protocol document: