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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
6
0.2 ug/day implant
0.5 ug/day implant
Wilmer Eye Institute, Johns Hopkins University
Baltimore, Maryland, United States
Mean Change From Baseline in Visual Acuity
Visual acuity is measured using ETDRS charts at 4 meters.
Time frame: 6 mos
Number of Patients Developing Cataracts
Time frame: 6 mos
Change in IOP From Baseline
IOP stands for intra ocular pressure
Time frame: 6 mos
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