Objective: To evaluate the efficacy and safety of photodynamic therapy with verteporfin combined with intravitreal triamcinolone in choroidal neovascularization secondary to agerelated macular degeneration (AMD). Desi...Objective: To evaluate the efficacy and safety of photodynamic therapy with verteporfin combined with intravitreal triamcinolone in choroidal neovascularization secondary to agerelated macular degeneration (AMD). Design: Prospective, noncomparative, interventional case series. Participants: One hundred eighty-four patients undergoing treatment for neovascular AMD at one retinal referral center. Methods: One hundred eighty-four eyes of 184 consecutive patients (63.6%female, 36.4%male) with a mean age of 76.5 years and a follow-up of a median of 38.8 weeks (range, 12-103) were included in a case series. One hundred forty-eight (80.4%) patients had subfoveal choroidal neovascularization, 19 patients (10.3%) had juxtafoveal choroidal neovascularization, and 17 patients (9.2%) had extrafoveal choroidal neovascularization. Verteporfin photodynamic therapy was performed using the recommended standard procedure. A solution containing 25 mg of triamcinolone was injected intravitreally 16 hours after photodynamic therapy in 184 patients. The combined therapy procedure was repeated at the 3-month follow-up visits whenever persistent choroidal neovascularization leakage was documented angiographically. Main Outcome Measures: Mean change in best-refracted visual acuity (VA) between baseline and the last visit, and number of treatments necessary to achieve absence of leakage. Results: Visual acuity improved in the majority of patients (baseline VA, mean 20/125) by a mean increase of 1.22 Snellen lines and 1.43 lines using laser interferometry (P< 0.01). The mean number of required treatments was 1.21. Twenty-three eyes (12.5%) required 2 treatments, 6 eyes (3.26%) required 3 treatments, and 1 eye (0.5%) required 4 treatments. The combination treatment including laser and intravitreal steroid administration was well tolerated. Forty-six patients (25%) required glaucoma therapy due to a transient steroid-induced intraocular pressure (IOP) increase. Twelve patients (6.5%)were on topical medication for preexisting glaucoma. Two patients (1%) whose IOP increase could not be controlled with topical therapy required surgery. Conclusions: Verteporfin photodynamic therapy combined with intravitreal triamcinolonemay improve the outcome of standard verteporfin photodynamic therapy in the treatment of choroidal neovascularization secondary to AMD. A significant improvement in VA was observed in a majority of treated patients and was maintained during the maximum follow-up. In addition, retreatment rates were lower than anticipated.展开更多
Background: Anecortave acetate is a synthetic derivative of cortisol, but very specific and irreversible chemical modifications to the cortisol structure have resulted in the creation of a potent inhibitor of blood ve...Background: Anecortave acetate is a synthetic derivative of cortisol, but very specific and irreversible chemical modifications to the cortisol structure have resulted in the creation of a potent inhibitor of blood vessel growth with no evidence non-clinically or clinically of glucocorticoid receptor-mediated bioactivity. The clinical safety of Anecortave Acetate administered as a posterior juxtascleral depot every 6 months for up to 4 years is reviewed in this manuscript. Methods: Clinical safety and efficacy of the novel angiostatic agent Anecortave Acetate for Depot Suspension was evaluated in patients with subfoveal exudative age-related macular degeneration (AMD)-in amasked, randomized, dose-duration clinical trial completed in June 2003. This safety and efficacy study enrolled and treated 128 patients at 18 clinical sites in the US and EU. This was the first clinical trial of Anecortave Acetate for Depot Suspension administered as a posterior juxtascleral depot. Assessments of clinical safety were made with general physical examinations including electrocardiograms and hematology/serum chemistry/urinalysis, detailed ophthalmic evaluations with fluorescein/ indocyanine green angiography and assessments of best-corrected logMAR visual acuity. All safety reports have been reviewed periodically by an Independent Safety Committee responsible for overseeing these activities. Results: No clinically relevant safety issues related to either Anecortave Acetate for Depot Suspension or the administration procedure have been identified by an Independent Safety Committee. The most frequent safety issues reported were cataractous changes, decreased visual acuity, ptosis, ocular pain, abnormal vision and subconjunctival hemorrhage, but the majority of these were assessed as unrelated to treatment. Conclusions: Anecortave Acetate for Depot Suspension (3, 15 and30 mg) is clinically safe following administration and re-administration at 6- month intervals as a posterior juxtascleral depot using a specially designed curved cannula.展开更多
文摘Objective: To evaluate the efficacy and safety of photodynamic therapy with verteporfin combined with intravitreal triamcinolone in choroidal neovascularization secondary to agerelated macular degeneration (AMD). Design: Prospective, noncomparative, interventional case series. Participants: One hundred eighty-four patients undergoing treatment for neovascular AMD at one retinal referral center. Methods: One hundred eighty-four eyes of 184 consecutive patients (63.6%female, 36.4%male) with a mean age of 76.5 years and a follow-up of a median of 38.8 weeks (range, 12-103) were included in a case series. One hundred forty-eight (80.4%) patients had subfoveal choroidal neovascularization, 19 patients (10.3%) had juxtafoveal choroidal neovascularization, and 17 patients (9.2%) had extrafoveal choroidal neovascularization. Verteporfin photodynamic therapy was performed using the recommended standard procedure. A solution containing 25 mg of triamcinolone was injected intravitreally 16 hours after photodynamic therapy in 184 patients. The combined therapy procedure was repeated at the 3-month follow-up visits whenever persistent choroidal neovascularization leakage was documented angiographically. Main Outcome Measures: Mean change in best-refracted visual acuity (VA) between baseline and the last visit, and number of treatments necessary to achieve absence of leakage. Results: Visual acuity improved in the majority of patients (baseline VA, mean 20/125) by a mean increase of 1.22 Snellen lines and 1.43 lines using laser interferometry (P< 0.01). The mean number of required treatments was 1.21. Twenty-three eyes (12.5%) required 2 treatments, 6 eyes (3.26%) required 3 treatments, and 1 eye (0.5%) required 4 treatments. The combination treatment including laser and intravitreal steroid administration was well tolerated. Forty-six patients (25%) required glaucoma therapy due to a transient steroid-induced intraocular pressure (IOP) increase. Twelve patients (6.5%)were on topical medication for preexisting glaucoma. Two patients (1%) whose IOP increase could not be controlled with topical therapy required surgery. Conclusions: Verteporfin photodynamic therapy combined with intravitreal triamcinolonemay improve the outcome of standard verteporfin photodynamic therapy in the treatment of choroidal neovascularization secondary to AMD. A significant improvement in VA was observed in a majority of treated patients and was maintained during the maximum follow-up. In addition, retreatment rates were lower than anticipated.
文摘Background: Anecortave acetate is a synthetic derivative of cortisol, but very specific and irreversible chemical modifications to the cortisol structure have resulted in the creation of a potent inhibitor of blood vessel growth with no evidence non-clinically or clinically of glucocorticoid receptor-mediated bioactivity. The clinical safety of Anecortave Acetate administered as a posterior juxtascleral depot every 6 months for up to 4 years is reviewed in this manuscript. Methods: Clinical safety and efficacy of the novel angiostatic agent Anecortave Acetate for Depot Suspension was evaluated in patients with subfoveal exudative age-related macular degeneration (AMD)-in amasked, randomized, dose-duration clinical trial completed in June 2003. This safety and efficacy study enrolled and treated 128 patients at 18 clinical sites in the US and EU. This was the first clinical trial of Anecortave Acetate for Depot Suspension administered as a posterior juxtascleral depot. Assessments of clinical safety were made with general physical examinations including electrocardiograms and hematology/serum chemistry/urinalysis, detailed ophthalmic evaluations with fluorescein/ indocyanine green angiography and assessments of best-corrected logMAR visual acuity. All safety reports have been reviewed periodically by an Independent Safety Committee responsible for overseeing these activities. Results: No clinically relevant safety issues related to either Anecortave Acetate for Depot Suspension or the administration procedure have been identified by an Independent Safety Committee. The most frequent safety issues reported were cataractous changes, decreased visual acuity, ptosis, ocular pain, abnormal vision and subconjunctival hemorrhage, but the majority of these were assessed as unrelated to treatment. Conclusions: Anecortave Acetate for Depot Suspension (3, 15 and30 mg) is clinically safe following administration and re-administration at 6- month intervals as a posterior juxtascleral depot using a specially designed curved cannula.
