Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration: twelve-month clinical outcomes

To evaluate safety and efficacy of the angiostatic agent anecortave acetate, compared with a placebo, for treatment of subfoveal choroidal neovascularization (CNV). Ongoing masked, randomized, placebo-controlled, parallel evaluation of anecortave acetate (30 mg, 15 mg, and 3 mg) versus a placebo. Th...

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Veröffentlicht in:Ophthalmology (Rochester, Minn.) Minn.), 2003-12, Vol.110 (12), p.2372-2383
Hauptverfasser: D'Amico, Donald J, Goldberg, Morton F, Hudson, Henry, Jerdan, Janice A, Krueger, D Scott, Luna, Susan P, Robertson, Stella M, Russell, Stephen, Singerman, Lawrence, Slakter, Jason S, Yannuzzi, Lawrence, Zilliox, Patricia
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container_issue 12
container_start_page 2372
container_title Ophthalmology (Rochester, Minn.)
container_volume 110
creator D'Amico, Donald J
Goldberg, Morton F
Hudson, Henry
Jerdan, Janice A
Krueger, D Scott
Luna, Susan P
Robertson, Stella M
Russell, Stephen
Singerman, Lawrence
Slakter, Jason S
Yannuzzi, Lawrence
Zilliox, Patricia
description To evaluate safety and efficacy of the angiostatic agent anecortave acetate, compared with a placebo, for treatment of subfoveal choroidal neovascularization (CNV). Ongoing masked, randomized, placebo-controlled, parallel evaluation of anecortave acetate (30 mg, 15 mg, and 3 mg) versus a placebo. There were 128 eyes of 128 patients with subfoveal CNV secondary to age-related macular degeneration who were enrolled and treated, with 80% (102/128) of eyes presenting with predominantly classic lesions at baseline. All eyes received a posterior juxtascleral depot application of masked study medication or a placebo, with retreatment at 6-month intervals if the masked investigator believed the patient could benefit. Patients received periodic detailed ophthalmic examinations with both fluorescein and indocyanine green angiography, general physical examinations with electrocardiograms, and hematology/serum chemistry/urinalysis. All ophthalmic and systemic safety data were periodically reviewed by the Independent Safety Committee overseeing the study. Best-corrected logarithm of the minimum angle of resolution (logMAR) vision and fluorescein angiographic lesion characteristics were compared over time and among treatment groups. At month 12, anecortave acetate (15 mg) administered at 6-month intervals was statistically superior to the placebo for 3 measures of clinical efficacy: mean change from baseline vision ( P = 0.0131), stabilization of vision (
doi_str_mv 10.1016/j.ophtha.2003.08.020
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Ongoing masked, randomized, placebo-controlled, parallel evaluation of anecortave acetate (30 mg, 15 mg, and 3 mg) versus a placebo. There were 128 eyes of 128 patients with subfoveal CNV secondary to age-related macular degeneration who were enrolled and treated, with 80% (102/128) of eyes presenting with predominantly classic lesions at baseline. All eyes received a posterior juxtascleral depot application of masked study medication or a placebo, with retreatment at 6-month intervals if the masked investigator believed the patient could benefit. Patients received periodic detailed ophthalmic examinations with both fluorescein and indocyanine green angiography, general physical examinations with electrocardiograms, and hematology/serum chemistry/urinalysis. All ophthalmic and systemic safety data were periodically reviewed by the Independent Safety Committee overseeing the study. Best-corrected logarithm of the minimum angle of resolution (logMAR) vision and fluorescein angiographic lesion characteristics were compared over time and among treatment groups. At month 12, anecortave acetate (15 mg) administered at 6-month intervals was statistically superior to the placebo for 3 measures of clinical efficacy: mean change from baseline vision ( P = 0.0131), stabilization of vision (&lt;3 logMAR line change; P = 0.0323), and prevention of severe vision loss (decrease of ≥6 logMAR lines from baseline; P = 0.0224). Subgroup analysis of predominantly classic lesions revealed that anecortave acetate (15 mg) was also superior to the placebo at 1 year for each of these 3 measures of visual outcome ( Ps = 0.0022, 0.0100, and 0.0299, respectively). Anecortave acetate (15 mg) trended toward significance over the placebo at month 12 for inhibition of total lesion growth and for inhibition of both the total CNV component and the classic CNV component in both the overall and subgroup analyses. The Independent Safety Committee identified no clinically relevant treatment-related safety issues. 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Best-corrected logarithm of the minimum angle of resolution (logMAR) vision and fluorescein angiographic lesion characteristics were compared over time and among treatment groups. At month 12, anecortave acetate (15 mg) administered at 6-month intervals was statistically superior to the placebo for 3 measures of clinical efficacy: mean change from baseline vision ( P = 0.0131), stabilization of vision (&lt;3 logMAR line change; P = 0.0323), and prevention of severe vision loss (decrease of ≥6 logMAR lines from baseline; P = 0.0224). Subgroup analysis of predominantly classic lesions revealed that anecortave acetate (15 mg) was also superior to the placebo at 1 year for each of these 3 measures of visual outcome ( Ps = 0.0022, 0.0100, and 0.0299, respectively). 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Anecortave acetate (15 mg) is safe and clinically efficacious at 1 year for maintaining vision, preventing severe vision loss, and inhibiting subfoveal CNV lesion growth.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Angiogenesis Inhibitors - therapeutic use</subject><subject>Choroidal Neovascularization - diagnosis</subject><subject>Choroidal Neovascularization - drug therapy</subject><subject>Choroidal Neovascularization - etiology</subject><subject>Coloring Agents</subject><subject>Double-Blind Method</subject><subject>Drug Evaluation</subject><subject>Female</subject><subject>Fluorescein Angiography</subject><subject>Follow-Up Studies</subject><subject>Fovea Centralis</subject><subject>Humans</subject><subject>Indocyanine Green</subject><subject>Macular Degeneration - complications</subject><subject>Macular Degeneration - diagnosis</subject><subject>Macular Degeneration - drug therapy</subject><subject>Male</subject><subject>Pregnadienediols - therapeutic use</subject><subject>Prospective Studies</subject><subject>Safety</subject><subject>Treatment Outcome</subject><subject>Visual Acuity</subject><issn>0161-6420</issn><issn>1549-4713</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1kUFv1DAQhS0EotvCP0DIJ24JHsdNYg5IVQUUqRIXOFsTZ9L1KrEX2wkqf4M_jJctp3eYT2_mzWPsDYgaBLTvD3U47vMeaylEU4u-FlI8Yzu4VrpSHTTP2a5gULVKigt2mdJBCNG2jXrJLkC1SnUSduzPjScbYsaNOFrKmIsmvgQf8p4iHh_5FCLPkTAv5DMPE0_rMIWNcOaewobJrjNG9xuzC547z_GBqkhzsRr5gv-mfKQH8sXvxHzg-RfNG1VlS95zOzvvbHELa7ZhofSKvZhwTvT6Sa_Yj8-fvt_eVfffvny9vbmvSLYyV9NEEoe2Q92AkHIaB7RglSDZgS5Zh15pTR0OqHsLNCDoHguq-9424rptrti7s-8xhp8rpWwWlyzNM5ZcazIdKFBaQgHfPoHrsNBojtEtGB_N_zcW4OMZoHLu5iiaZB15S6OLZLMZgzMgzKk3czDn3sypNyN6U3pr_gIppZAG</recordid><startdate>20031201</startdate><enddate>20031201</enddate><creator>D'Amico, Donald J</creator><creator>Goldberg, Morton F</creator><creator>Hudson, Henry</creator><creator>Jerdan, Janice A</creator><creator>Krueger, D Scott</creator><creator>Luna, Susan P</creator><creator>Robertson, Stella M</creator><creator>Russell, Stephen</creator><creator>Singerman, Lawrence</creator><creator>Slakter, Jason S</creator><creator>Yannuzzi, Lawrence</creator><creator>Zilliox, Patricia</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20031201</creationdate><title>Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration: twelve-month clinical outcomes</title><author>D'Amico, Donald J ; 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Ongoing masked, randomized, placebo-controlled, parallel evaluation of anecortave acetate (30 mg, 15 mg, and 3 mg) versus a placebo. There were 128 eyes of 128 patients with subfoveal CNV secondary to age-related macular degeneration who were enrolled and treated, with 80% (102/128) of eyes presenting with predominantly classic lesions at baseline. All eyes received a posterior juxtascleral depot application of masked study medication or a placebo, with retreatment at 6-month intervals if the masked investigator believed the patient could benefit. Patients received periodic detailed ophthalmic examinations with both fluorescein and indocyanine green angiography, general physical examinations with electrocardiograms, and hematology/serum chemistry/urinalysis. All ophthalmic and systemic safety data were periodically reviewed by the Independent Safety Committee overseeing the study. Best-corrected logarithm of the minimum angle of resolution (logMAR) vision and fluorescein angiographic lesion characteristics were compared over time and among treatment groups. At month 12, anecortave acetate (15 mg) administered at 6-month intervals was statistically superior to the placebo for 3 measures of clinical efficacy: mean change from baseline vision ( P = 0.0131), stabilization of vision (&lt;3 logMAR line change; P = 0.0323), and prevention of severe vision loss (decrease of ≥6 logMAR lines from baseline; P = 0.0224). Subgroup analysis of predominantly classic lesions revealed that anecortave acetate (15 mg) was also superior to the placebo at 1 year for each of these 3 measures of visual outcome ( Ps = 0.0022, 0.0100, and 0.0299, respectively). Anecortave acetate (15 mg) trended toward significance over the placebo at month 12 for inhibition of total lesion growth and for inhibition of both the total CNV component and the classic CNV component in both the overall and subgroup analyses. The Independent Safety Committee identified no clinically relevant treatment-related safety issues. Anecortave acetate (15 mg) is safe and clinically efficacious at 1 year for maintaining vision, preventing severe vision loss, and inhibiting subfoveal CNV lesion growth.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>14644721</pmid><doi>10.1016/j.ophtha.2003.08.020</doi><tpages>12</tpages></addata></record>
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subjects Aged
Aged, 80 and over
Angiogenesis Inhibitors - therapeutic use
Choroidal Neovascularization - diagnosis
Choroidal Neovascularization - drug therapy
Choroidal Neovascularization - etiology
Coloring Agents
Double-Blind Method
Drug Evaluation
Female
Fluorescein Angiography
Follow-Up Studies
Fovea Centralis
Humans
Indocyanine Green
Macular Degeneration - complications
Macular Degeneration - diagnosis
Macular Degeneration - drug therapy
Male
Pregnadienediols - therapeutic use
Prospective Studies
Safety
Treatment Outcome
Visual Acuity
title Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration: twelve-month clinical outcomes
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