Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema

To assess long-term efficacy and safety of intravitreal inserts releasing 0.2 μg/d (low dose) or 0.5 μg/d (high dose) fluocinolone acetonide (FAc) in patients with diabetic macular edema (DME). Two randomized, sham injection-controlled, double-masked, multicenter clinical trials. Subjects with persi...

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Veröffentlicht in:	Ophthalmology (Rochester, Minn.) Jg. 119; H. 10; S. 2125
Hauptverfasser:	Campochiaro, Peter A, Brown, David M, Pearson, Andrew, Chen, Sanford, Boyer, David, Ruiz-Moreno, Jose, Garretson, Bruce, Gupta, Amod, Hariprasad, Seenu M, Bailey, Clare, Reichel, Elias, Soubrane, Gisele, Kapik, Barry, Billman, Kathleen, Kane, Frances E, Green, Kenneth
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States 01.10.2012
Schlagworte:	Antihypertensive Agents - therapeutic use Cataract - etiology Cataract - therapy Diabetic Retinopathy - diagnosis Diabetic Retinopathy - drug therapy Double-Blind Method Drug Implants Fluocinolone Acetonide - administration & dosage Fluocinolone Acetonide - adverse effects Fluorescein Angiography Follow-Up Studies Glaucoma - etiology Glaucoma - surgery Glucocorticoids - administration & dosage Glucocorticoids - adverse effects Humans Macular Edema - diagnosis Macular Edema - drug therapy Phacoemulsification Tomography, Optical Coherence Trabeculectomy Treatment Outcome Visual Acuity - physiology Vitreous Body
ISSN:	1549-4713, 1549-4713
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Abstract	To assess long-term efficacy and safety of intravitreal inserts releasing 0.2 μg/d (low dose) or 0.5 μg/d (high dose) fluocinolone acetonide (FAc) in patients with diabetic macular edema (DME). Two randomized, sham injection-controlled, double-masked, multicenter clinical trials. Subjects with persistent DME despite ≥1 macular laser treatment were randomized 1:2:2 to sham injection (n = 185), low-dose insert (n = 375), or high-dose insert (n = 393). Subjects received study drug or sham injection and after 6 weeks were eligible for rescue laser. Based on retreatment criteria, additional study drug or sham injections could be given after 1 year. Percentage of patients with improvement of ≥15 letters from baseline. Secondary outcomes included other parameters of visual function and foveal thickness. At month 36, the percentage of patients who gained ≥15 in letter score using the last observation carried forward method was 28.7% (low dose) and 27.8% (high dose) in the FAc insert groups compared with 18.9% (P = 0.018) in the sham group, and considering only those patients still in the trial at month 36, it was 33.0% (low dose) and 31.9% (high dose) compared with 21.4% in the sham group (P = 0.030). Preplanned subgroup analysis demonstrated a doubling of benefit compared with sham injections in patients who reported duration of DME ≥3 years at baseline; the percentage who gained ≥15 in letter score at month 36 was 34.0% (low dose; P<0.001) or 28.8% (high dose; P = 0.002) compared with 13.4% (sham). An improvement ≥2 steps in the Early Treatment Diabetic Retinopathy Study retinopathy scale occurred in 13.7% (low dose) and 10.1% (high dose) compared with 8.9% in the sham group. Almost all phakic patients in the FAc insert groups developed cataract, but their visual benefit after cataract surgery was similar to that in pseudophakic patients. The incidence of incisional glaucoma surgery at month 36 was 4.8% in the low-dose group and 8.1% in the high-dose insert group. In patients with DME FAc inserts provide substantial visual benefit for up to 3 years and would provide a valuable addition to the options available for patients with DME.
AbstractList	To assess long-term efficacy and safety of intravitreal inserts releasing 0.2 μg/d (low dose) or 0.5 μg/d (high dose) fluocinolone acetonide (FAc) in patients with diabetic macular edema (DME).OBJECTIVETo assess long-term efficacy and safety of intravitreal inserts releasing 0.2 μg/d (low dose) or 0.5 μg/d (high dose) fluocinolone acetonide (FAc) in patients with diabetic macular edema (DME).Two randomized, sham injection-controlled, double-masked, multicenter clinical trials.DESIGNTwo randomized, sham injection-controlled, double-masked, multicenter clinical trials.Subjects with persistent DME despite ≥1 macular laser treatment were randomized 1:2:2 to sham injection (n = 185), low-dose insert (n = 375), or high-dose insert (n = 393).PARTICIPANTSSubjects with persistent DME despite ≥1 macular laser treatment were randomized 1:2:2 to sham injection (n = 185), low-dose insert (n = 375), or high-dose insert (n = 393).Subjects received study drug or sham injection and after 6 weeks were eligible for rescue laser. Based on retreatment criteria, additional study drug or sham injections could be given after 1 year.METHODSSubjects received study drug or sham injection and after 6 weeks were eligible for rescue laser. Based on retreatment criteria, additional study drug or sham injections could be given after 1 year.Percentage of patients with improvement of ≥15 letters from baseline. Secondary outcomes included other parameters of visual function and foveal thickness.MAIN OUTCOME MEASURESPercentage of patients with improvement of ≥15 letters from baseline. Secondary outcomes included other parameters of visual function and foveal thickness.At month 36, the percentage of patients who gained ≥15 in letter score using the last observation carried forward method was 28.7% (low dose) and 27.8% (high dose) in the FAc insert groups compared with 18.9% (P = 0.018) in the sham group, and considering only those patients still in the trial at month 36, it was 33.0% (low dose) and 31.9% (high dose) compared with 21.4% in the sham group (P = 0.030). Preplanned subgroup analysis demonstrated a doubling of benefit compared with sham injections in patients who reported duration of DME ≥3 years at baseline; the percentage who gained ≥15 in letter score at month 36 was 34.0% (low dose; P<0.001) or 28.8% (high dose; P = 0.002) compared with 13.4% (sham). An improvement ≥2 steps in the Early Treatment Diabetic Retinopathy Study retinopathy scale occurred in 13.7% (low dose) and 10.1% (high dose) compared with 8.9% in the sham group. Almost all phakic patients in the FAc insert groups developed cataract, but their visual benefit after cataract surgery was similar to that in pseudophakic patients. The incidence of incisional glaucoma surgery at month 36 was 4.8% in the low-dose group and 8.1% in the high-dose insert group.RESULTSAt month 36, the percentage of patients who gained ≥15 in letter score using the last observation carried forward method was 28.7% (low dose) and 27.8% (high dose) in the FAc insert groups compared with 18.9% (P = 0.018) in the sham group, and considering only those patients still in the trial at month 36, it was 33.0% (low dose) and 31.9% (high dose) compared with 21.4% in the sham group (P = 0.030). Preplanned subgroup analysis demonstrated a doubling of benefit compared with sham injections in patients who reported duration of DME ≥3 years at baseline; the percentage who gained ≥15 in letter score at month 36 was 34.0% (low dose; P<0.001) or 28.8% (high dose; P = 0.002) compared with 13.4% (sham). An improvement ≥2 steps in the Early Treatment Diabetic Retinopathy Study retinopathy scale occurred in 13.7% (low dose) and 10.1% (high dose) compared with 8.9% in the sham group. Almost all phakic patients in the FAc insert groups developed cataract, but their visual benefit after cataract surgery was similar to that in pseudophakic patients. The incidence of incisional glaucoma surgery at month 36 was 4.8% in the low-dose group and 8.1% in the high-dose insert group.In patients with DME FAc inserts provide substantial visual benefit for up to 3 years and would provide a valuable addition to the options available for patients with DME.CONCLUSIONSIn patients with DME FAc inserts provide substantial visual benefit for up to 3 years and would provide a valuable addition to the options available for patients with DME. To assess long-term efficacy and safety of intravitreal inserts releasing 0.2 μg/d (low dose) or 0.5 μg/d (high dose) fluocinolone acetonide (FAc) in patients with diabetic macular edema (DME). Two randomized, sham injection-controlled, double-masked, multicenter clinical trials. Subjects with persistent DME despite ≥1 macular laser treatment were randomized 1:2:2 to sham injection (n = 185), low-dose insert (n = 375), or high-dose insert (n = 393). Subjects received study drug or sham injection and after 6 weeks were eligible for rescue laser. Based on retreatment criteria, additional study drug or sham injections could be given after 1 year. Percentage of patients with improvement of ≥15 letters from baseline. Secondary outcomes included other parameters of visual function and foveal thickness. At month 36, the percentage of patients who gained ≥15 in letter score using the last observation carried forward method was 28.7% (low dose) and 27.8% (high dose) in the FAc insert groups compared with 18.9% (P = 0.018) in the sham group, and considering only those patients still in the trial at month 36, it was 33.0% (low dose) and 31.9% (high dose) compared with 21.4% in the sham group (P = 0.030). Preplanned subgroup analysis demonstrated a doubling of benefit compared with sham injections in patients who reported duration of DME ≥3 years at baseline; the percentage who gained ≥15 in letter score at month 36 was 34.0% (low dose; P<0.001) or 28.8% (high dose; P = 0.002) compared with 13.4% (sham). An improvement ≥2 steps in the Early Treatment Diabetic Retinopathy Study retinopathy scale occurred in 13.7% (low dose) and 10.1% (high dose) compared with 8.9% in the sham group. Almost all phakic patients in the FAc insert groups developed cataract, but their visual benefit after cataract surgery was similar to that in pseudophakic patients. The incidence of incisional glaucoma surgery at month 36 was 4.8% in the low-dose group and 8.1% in the high-dose insert group. In patients with DME FAc inserts provide substantial visual benefit for up to 3 years and would provide a valuable addition to the options available for patients with DME.
Author	Brown, David M Chen, Sanford Kapik, Barry Boyer, David Billman, Kathleen Gupta, Amod Hariprasad, Seenu M Garretson, Bruce Ruiz-Moreno, Jose Reichel, Elias Soubrane, Gisele Green, Kenneth Kane, Frances E Campochiaro, Peter A Pearson, Andrew Bailey, Clare
Author_xml	– sequence: 1 givenname: Peter A surname: Campochiaro fullname: Campochiaro, Peter A email: pcampo@jhmi.edu organization: Wilmer Eye Institute, Baltimore, Maryland, USA. pcampo@jhmi.edu – sequence: 2 givenname: David M surname: Brown fullname: Brown, David M – sequence: 3 givenname: Andrew surname: Pearson fullname: Pearson, Andrew – sequence: 4 givenname: Sanford surname: Chen fullname: Chen, Sanford – sequence: 5 givenname: David surname: Boyer fullname: Boyer, David – sequence: 6 givenname: Jose surname: Ruiz-Moreno fullname: Ruiz-Moreno, Jose – sequence: 7 givenname: Bruce surname: Garretson fullname: Garretson, Bruce – sequence: 8 givenname: Amod surname: Gupta fullname: Gupta, Amod – sequence: 9 givenname: Seenu M surname: Hariprasad fullname: Hariprasad, Seenu M – sequence: 10 givenname: Clare surname: Bailey fullname: Bailey, Clare – sequence: 11 givenname: Elias surname: Reichel fullname: Reichel, Elias – sequence: 12 givenname: Gisele surname: Soubrane fullname: Soubrane, Gisele – sequence: 13 givenname: Barry surname: Kapik fullname: Kapik, Barry – sequence: 14 givenname: Kathleen surname: Billman fullname: Billman, Kathleen – sequence: 15 givenname: Frances E surname: Kane fullname: Kane, Frances E – sequence: 16 givenname: Kenneth surname: Green fullname: Green, Kenneth
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/22727177$$D View this record in MEDLINE/PubMed
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Copyright	Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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Snippet	To assess long-term efficacy and safety of intravitreal inserts releasing 0.2 μg/d (low dose) or 0.5 μg/d (high dose) fluocinolone acetonide (FAc) in patients...
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SubjectTerms	Antihypertensive Agents - therapeutic use Cataract - etiology Cataract - therapy Diabetic Retinopathy - diagnosis Diabetic Retinopathy - drug therapy Double-Blind Method Drug Implants Fluocinolone Acetonide - administration & dosage Fluocinolone Acetonide - adverse effects Fluorescein Angiography Follow-Up Studies Glaucoma - etiology Glaucoma - surgery Glucocorticoids - administration & dosage Glucocorticoids - adverse effects Humans Macular Edema - diagnosis Macular Edema - drug therapy Phacoemulsification Tomography, Optical Coherence Trabeculectomy Treatment Outcome Visual Acuity - physiology Vitreous Body
Title	Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema
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