Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis

To evaluate the effect of a single treatment with dexamethasone intravitreal implant (DEX implant) on patient-reported visual functioning in patients with noninfectious intermediate or posterior uveitis. Patient eyes with noninfectious intermediate or posterior uveitis were randomized to a single tr...

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Veröffentlicht in:Investigative ophthalmology & visual science 2013-07, Vol.54 (7), p.4864-4870
Hauptverfasser: Lightman, Susan, Belfort, Jr, Rubens, Naik, Rupali K, Lowder, Careen, Foster, C Stephen, Rentz, Anne M, Cui, Harry, Whitcup, Scott M, Kowalski, Jonathan W, Revicki, Dennis A
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container_end_page 4870
container_issue 7
container_start_page 4864
container_title Investigative ophthalmology & visual science
container_volume 54
creator Lightman, Susan
Belfort, Jr, Rubens
Naik, Rupali K
Lowder, Careen
Foster, C Stephen
Rentz, Anne M
Cui, Harry
Whitcup, Scott M
Kowalski, Jonathan W
Revicki, Dennis A
description To evaluate the effect of a single treatment with dexamethasone intravitreal implant (DEX implant) on patient-reported visual functioning in patients with noninfectious intermediate or posterior uveitis. Patient eyes with noninfectious intermediate or posterior uveitis were randomized to a single treatment with DEX implant 0.70 mg (n=77), DEX implant 0.35 mg (n=76), or a sham procedure (n=76) and followed for 26 weeks. Vision-related functioning was measured using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) assessed at baseline and at weeks 8, 16, and 26 or early exit. Analysis of covariance and mixed model analysis of covariance were used to compare vision-related functioning between the DEX implant 0.70 and 0.35 mg groups and the sham group. By 8 weeks, the DEX implant 0.70 mg group demonstrated significant improvements in NEI VFQ-25 subscales near vision (P=0.031), distance vision (P=0.023), peripheral vision (P=0.045), vision-specific social functioning (P=0.019), and the NEI VFQ-25 composite score (P=0.007) compared with sham. After 26 weeks, the DEX implant 0.70 mg group reported significant improvements in NEI VFQ-25 subscales distance vision (P=0.003), vision-specific role difficulties (P=0.038), vision-specific dependency (P=0.017), vision-specific social functioning (P=0.009), vision-specific mental health (P=0.036), and the composite score (P=0.001) compared with sham. In patients with noninfectious intermediate or posterior uveitis receiving a single treatment of DEX implant 0.70 mg, significant and clinically meaningful improvements in patient-reported visual functioning were observed as early as week 8 and were maintained over 26 weeks. (ClinicalTrials.gov number, NCT00333814.).
doi_str_mv 10.1167/iovs.12-10981
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Patient eyes with noninfectious intermediate or posterior uveitis were randomized to a single treatment with DEX implant 0.70 mg (n=77), DEX implant 0.35 mg (n=76), or a sham procedure (n=76) and followed for 26 weeks. Vision-related functioning was measured using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) assessed at baseline and at weeks 8, 16, and 26 or early exit. Analysis of covariance and mixed model analysis of covariance were used to compare vision-related functioning between the DEX implant 0.70 and 0.35 mg groups and the sham group. By 8 weeks, the DEX implant 0.70 mg group demonstrated significant improvements in NEI VFQ-25 subscales near vision (P=0.031), distance vision (P=0.023), peripheral vision (P=0.045), vision-specific social functioning (P=0.019), and the NEI VFQ-25 composite score (P=0.007) compared with sham. After 26 weeks, the DEX implant 0.70 mg group reported significant improvements in NEI VFQ-25 subscales distance vision (P=0.003), vision-specific role difficulties (P=0.038), vision-specific dependency (P=0.017), vision-specific social functioning (P=0.009), vision-specific mental health (P=0.036), and the composite score (P=0.001) compared with sham. In patients with noninfectious intermediate or posterior uveitis receiving a single treatment of DEX implant 0.70 mg, significant and clinically meaningful improvements in patient-reported visual functioning were observed as early as week 8 and were maintained over 26 weeks. 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Patient eyes with noninfectious intermediate or posterior uveitis were randomized to a single treatment with DEX implant 0.70 mg (n=77), DEX implant 0.35 mg (n=76), or a sham procedure (n=76) and followed for 26 weeks. Vision-related functioning was measured using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) assessed at baseline and at weeks 8, 16, and 26 or early exit. Analysis of covariance and mixed model analysis of covariance were used to compare vision-related functioning between the DEX implant 0.70 and 0.35 mg groups and the sham group. By 8 weeks, the DEX implant 0.70 mg group demonstrated significant improvements in NEI VFQ-25 subscales near vision (P=0.031), distance vision (P=0.023), peripheral vision (P=0.045), vision-specific social functioning (P=0.019), and the NEI VFQ-25 composite score (P=0.007) compared with sham. After 26 weeks, the DEX implant 0.70 mg group reported significant improvements in NEI VFQ-25 subscales distance vision (P=0.003), vision-specific role difficulties (P=0.038), vision-specific dependency (P=0.017), vision-specific social functioning (P=0.009), vision-specific mental health (P=0.036), and the composite score (P=0.001) compared with sham. In patients with noninfectious intermediate or posterior uveitis receiving a single treatment of DEX implant 0.70 mg, significant and clinically meaningful improvements in patient-reported visual functioning were observed as early as week 8 and were maintained over 26 weeks. (ClinicalTrials.gov number, NCT00333814.).</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Analysis of Variance</subject><subject>Anti-Inflammatory Agents - administration &amp; dosage</subject><subject>Dexamethasone - administration &amp; dosage</subject><subject>Drug Implants</subject><subject>Female</subject><subject>Humans</subject><subject>Intravitreal Injections</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Surveys and Questionnaires</subject><subject>Uveitis, Posterior - drug therapy</subject><subject>Uveitis, Posterior - physiopathology</subject><subject>Visual Acuity - physiology</subject><subject>Young Adult</subject><issn>1552-5783</issn><issn>1552-5783</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpNkD1PwzAQhi0EolAYWZFHlhSfkzT2iCq-pEoswBo57hmMkrjYTgUSPx6HFsTk06vHr-4eQs6AzQDm1aV1mzADngGTAvbIEZQlz8pK5Pv_5gk5DuGNMQ7A2SGZ8LyaAxPVEfl6tsG6PvPYqograoZexxTY_oW6IWrXYaDO0BV-qA7jqwquR2r76NXGRo-qpbZbt6qPKaT9-NHg2DCEkULf4cqmZuo8XbuQApumYYM22nBCDoxqA57u3il5url-XNxly4fb-8XVMtN5zmMmlKikkShQSt40WGjdKFMWWhlWzJmEooAGJKzU3HAJjZQiR6iaEgvU0Ih8Si62vWvv3gcMse5s0NimtTEtWkORVHJR8DKh2RbV3oXg0dRrbzvlP2tg9Si8HoXXwOsf4Yk_31UPTTr1j_41nH8D7TSA-g</recordid><startdate>20130718</startdate><enddate>20130718</enddate><creator>Lightman, Susan</creator><creator>Belfort, Jr, Rubens</creator><creator>Naik, Rupali K</creator><creator>Lowder, Careen</creator><creator>Foster, C Stephen</creator><creator>Rentz, Anne M</creator><creator>Cui, Harry</creator><creator>Whitcup, Scott M</creator><creator>Kowalski, Jonathan W</creator><creator>Revicki, Dennis A</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20130718</creationdate><title>Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis</title><author>Lightman, Susan ; Belfort, Jr, Rubens ; Naik, Rupali K ; Lowder, Careen ; Foster, C Stephen ; Rentz, Anne M ; Cui, Harry ; Whitcup, Scott M ; Kowalski, Jonathan W ; Revicki, Dennis A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c332t-8a879f9e8e992bbe4ccbaf54caf046091441b191da6f291b9983e17b5e4ec1b83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Analysis of Variance</topic><topic>Anti-Inflammatory Agents - administration &amp; dosage</topic><topic>Dexamethasone - administration &amp; dosage</topic><topic>Drug Implants</topic><topic>Female</topic><topic>Humans</topic><topic>Intravitreal Injections</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Surveys and Questionnaires</topic><topic>Uveitis, Posterior - drug therapy</topic><topic>Uveitis, Posterior - physiopathology</topic><topic>Visual Acuity - physiology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lightman, Susan</creatorcontrib><creatorcontrib>Belfort, Jr, Rubens</creatorcontrib><creatorcontrib>Naik, Rupali K</creatorcontrib><creatorcontrib>Lowder, Careen</creatorcontrib><creatorcontrib>Foster, C Stephen</creatorcontrib><creatorcontrib>Rentz, Anne M</creatorcontrib><creatorcontrib>Cui, Harry</creatorcontrib><creatorcontrib>Whitcup, Scott M</creatorcontrib><creatorcontrib>Kowalski, Jonathan W</creatorcontrib><creatorcontrib>Revicki, Dennis A</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Investigative ophthalmology &amp; visual science</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lightman, Susan</au><au>Belfort, Jr, Rubens</au><au>Naik, Rupali K</au><au>Lowder, Careen</au><au>Foster, C Stephen</au><au>Rentz, Anne M</au><au>Cui, Harry</au><au>Whitcup, Scott M</au><au>Kowalski, Jonathan W</au><au>Revicki, Dennis A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis</atitle><jtitle>Investigative ophthalmology &amp; visual science</jtitle><addtitle>Invest Ophthalmol Vis Sci</addtitle><date>2013-07-18</date><risdate>2013</risdate><volume>54</volume><issue>7</issue><spage>4864</spage><epage>4870</epage><pages>4864-4870</pages><issn>1552-5783</issn><eissn>1552-5783</eissn><abstract>To evaluate the effect of a single treatment with dexamethasone intravitreal implant (DEX implant) on patient-reported visual functioning in patients with noninfectious intermediate or posterior uveitis. Patient eyes with noninfectious intermediate or posterior uveitis were randomized to a single treatment with DEX implant 0.70 mg (n=77), DEX implant 0.35 mg (n=76), or a sham procedure (n=76) and followed for 26 weeks. Vision-related functioning was measured using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) assessed at baseline and at weeks 8, 16, and 26 or early exit. Analysis of covariance and mixed model analysis of covariance were used to compare vision-related functioning between the DEX implant 0.70 and 0.35 mg groups and the sham group. By 8 weeks, the DEX implant 0.70 mg group demonstrated significant improvements in NEI VFQ-25 subscales near vision (P=0.031), distance vision (P=0.023), peripheral vision (P=0.045), vision-specific social functioning (P=0.019), and the NEI VFQ-25 composite score (P=0.007) compared with sham. After 26 weeks, the DEX implant 0.70 mg group reported significant improvements in NEI VFQ-25 subscales distance vision (P=0.003), vision-specific role difficulties (P=0.038), vision-specific dependency (P=0.017), vision-specific social functioning (P=0.009), vision-specific mental health (P=0.036), and the composite score (P=0.001) compared with sham. In patients with noninfectious intermediate or posterior uveitis receiving a single treatment of DEX implant 0.70 mg, significant and clinically meaningful improvements in patient-reported visual functioning were observed as early as week 8 and were maintained over 26 weeks. (ClinicalTrials.gov number, NCT00333814.).</abstract><cop>United States</cop><pmid>23761087</pmid><doi>10.1167/iovs.12-10981</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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subjects Adolescent
Adult
Aged
Aged, 80 and over
Analysis of Variance
Anti-Inflammatory Agents - administration & dosage
Dexamethasone - administration & dosage
Drug Implants
Female
Humans
Intravitreal Injections
Male
Middle Aged
Surveys and Questionnaires
Uveitis, Posterior - drug therapy
Uveitis, Posterior - physiopathology
Visual Acuity - physiology
Young Adult
title Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis
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