Vision-related function after ranibizumab treatment for diabetic macular edema

Results from RIDE and RISE

Neil M Bressler, Rohit Varma, Ivan J. Suñer, Chantal M. Dolan, James Ward, Jason S. Ehrlich, Shoshana Colman, Adam Turpcu

Research output: Contribution to journalArticle

Abstract

Objective: To examine the effects of intravitreal ranibizumab (Lucentis; Genentech, Inc., South San Francisco, CA) treatment on patient-reported vision-related function, as assessed by 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores, in patients with visual impairment secondary to center-involved diabetic macular edema (DME). Design: Within 2 randomized, double-masked, phase 3 clinical trials (RIDE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473382] and RISE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473330]), the NEI VFQ-25 was administered at baseline and at the 6-, 12-, 18-, and 24-month follow-up visits. Participants: Three hundred eighty-two (100%) RIDE patients and 377 (100%) RISE patients. Intervention Patients were randomized 1:1:1 to monthly injections of intravitreal ranibizumab 0.3 or 0.5 mg or sham. Study participants could receive macular laser for DME from month 3 onward if specific criteria were met. Main Outcome Measures: Exploratory post hoc analysis of mean change from baseline in NEI VFQ-25 scores at 12 and 24 months. Results: Across all treatment arms, 13% to 28% of enrolled eyes were the better-seeing eye. For all eyes in RIDE and RISE, the mean change in NEI VFQ-25 composite score improved more in ranibizumab-treated eyes at both the 12- and 24-month visits compared with sham treatment. For the better-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 10.9 more (95% confidence interval [CI], 2.5-19.2) than sham for RIDE patients and 1.3 more (95% CI, -10.5 to 13.0) than sham for RISE patients. For the worse-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 1.0 more (95% CI, -4.7 to 6.7) than sham for RIDE patients and 1.8 more (95% CI, -2.7 to 6.2) than sham for RISE patients. Similar results for most of these outcomes were seen with 0.5 mg ranibizumab. Conclusions: These phase 3 trials demonstrated that ranibizumab treatment for DME likely improves patient-reported vision-related function outcomes compared with sham, further supporting treatment of DME with ranibizumab.

Original languageEnglish (US)
Pages (from-to)2461-2472
Number of pages12
JournalOphthalmology
Volume121
Issue number12
DOIs
StatePublished - Dec 1 2014

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Macular Edema
Therapeutics
Confidence Intervals
Diabetes Mellitus
Ranibizumab
National Eye Institute (U.S.)
Phase III Clinical Trials
Intravitreal Injections
Injections
San Francisco
Vision Disorders
Lasers
Arm
Placebos
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Ophthalmology
  • Medicine(all)

Cite this

Vision-related function after ranibizumab treatment for diabetic macular edema : Results from RIDE and RISE. / Bressler, Neil M; Varma, Rohit; Suñer, Ivan J.; Dolan, Chantal M.; Ward, James; Ehrlich, Jason S.; Colman, Shoshana; Turpcu, Adam.

In: Ophthalmology, Vol. 121, No. 12, 01.12.2014, p. 2461-2472.

Research output: Contribution to journalArticle

Bressler, NM, Varma, R, Suñer, IJ, Dolan, CM, Ward, J, Ehrlich, JS, Colman, S & Turpcu, A 2014, 'Vision-related function after ranibizumab treatment for diabetic macular edema: Results from RIDE and RISE', Ophthalmology, vol. 121, no. 12, pp. 2461-2472. https://doi.org/10.1016/j.ophtha.2014.07.008
Bressler, Neil M ; Varma, Rohit ; Suñer, Ivan J. ; Dolan, Chantal M. ; Ward, James ; Ehrlich, Jason S. ; Colman, Shoshana ; Turpcu, Adam. / Vision-related function after ranibizumab treatment for diabetic macular edema : Results from RIDE and RISE. In: Ophthalmology. 2014 ; Vol. 121, No. 12. pp. 2461-2472.
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abstract = "Objective: To examine the effects of intravitreal ranibizumab (Lucentis; Genentech, Inc., South San Francisco, CA) treatment on patient-reported vision-related function, as assessed by 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores, in patients with visual impairment secondary to center-involved diabetic macular edema (DME). Design: Within 2 randomized, double-masked, phase 3 clinical trials (RIDE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473382] and RISE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473330]), the NEI VFQ-25 was administered at baseline and at the 6-, 12-, 18-, and 24-month follow-up visits. Participants: Three hundred eighty-two (100{\%}) RIDE patients and 377 (100{\%}) RISE patients. Intervention Patients were randomized 1:1:1 to monthly injections of intravitreal ranibizumab 0.3 or 0.5 mg or sham. Study participants could receive macular laser for DME from month 3 onward if specific criteria were met. Main Outcome Measures: Exploratory post hoc analysis of mean change from baseline in NEI VFQ-25 scores at 12 and 24 months. Results: Across all treatment arms, 13{\%} to 28{\%} of enrolled eyes were the better-seeing eye. For all eyes in RIDE and RISE, the mean change in NEI VFQ-25 composite score improved more in ranibizumab-treated eyes at both the 12- and 24-month visits compared with sham treatment. For the better-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 10.9 more (95{\%} confidence interval [CI], 2.5-19.2) than sham for RIDE patients and 1.3 more (95{\%} CI, -10.5 to 13.0) than sham for RISE patients. For the worse-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 1.0 more (95{\%} CI, -4.7 to 6.7) than sham for RIDE patients and 1.8 more (95{\%} CI, -2.7 to 6.2) than sham for RISE patients. Similar results for most of these outcomes were seen with 0.5 mg ranibizumab. Conclusions: These phase 3 trials demonstrated that ranibizumab treatment for DME likely improves patient-reported vision-related function outcomes compared with sham, further supporting treatment of DME with ranibizumab.",
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T1 - Vision-related function after ranibizumab treatment for diabetic macular edema

T2 - Results from RIDE and RISE

AU - Bressler, Neil M

AU - Varma, Rohit

AU - Suñer, Ivan J.

AU - Dolan, Chantal M.

AU - Ward, James

AU - Ehrlich, Jason S.

AU - Colman, Shoshana

AU - Turpcu, Adam

PY - 2014/12/1

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N2 - Objective: To examine the effects of intravitreal ranibizumab (Lucentis; Genentech, Inc., South San Francisco, CA) treatment on patient-reported vision-related function, as assessed by 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores, in patients with visual impairment secondary to center-involved diabetic macular edema (DME). Design: Within 2 randomized, double-masked, phase 3 clinical trials (RIDE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473382] and RISE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473330]), the NEI VFQ-25 was administered at baseline and at the 6-, 12-, 18-, and 24-month follow-up visits. Participants: Three hundred eighty-two (100%) RIDE patients and 377 (100%) RISE patients. Intervention Patients were randomized 1:1:1 to monthly injections of intravitreal ranibizumab 0.3 or 0.5 mg or sham. Study participants could receive macular laser for DME from month 3 onward if specific criteria were met. Main Outcome Measures: Exploratory post hoc analysis of mean change from baseline in NEI VFQ-25 scores at 12 and 24 months. Results: Across all treatment arms, 13% to 28% of enrolled eyes were the better-seeing eye. For all eyes in RIDE and RISE, the mean change in NEI VFQ-25 composite score improved more in ranibizumab-treated eyes at both the 12- and 24-month visits compared with sham treatment. For the better-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 10.9 more (95% confidence interval [CI], 2.5-19.2) than sham for RIDE patients and 1.3 more (95% CI, -10.5 to 13.0) than sham for RISE patients. For the worse-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 1.0 more (95% CI, -4.7 to 6.7) than sham for RIDE patients and 1.8 more (95% CI, -2.7 to 6.2) than sham for RISE patients. Similar results for most of these outcomes were seen with 0.5 mg ranibizumab. Conclusions: These phase 3 trials demonstrated that ranibizumab treatment for DME likely improves patient-reported vision-related function outcomes compared with sham, further supporting treatment of DME with ranibizumab.

AB - Objective: To examine the effects of intravitreal ranibizumab (Lucentis; Genentech, Inc., South San Francisco, CA) treatment on patient-reported vision-related function, as assessed by 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores, in patients with visual impairment secondary to center-involved diabetic macular edema (DME). Design: Within 2 randomized, double-masked, phase 3 clinical trials (RIDE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473382] and RISE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473330]), the NEI VFQ-25 was administered at baseline and at the 6-, 12-, 18-, and 24-month follow-up visits. Participants: Three hundred eighty-two (100%) RIDE patients and 377 (100%) RISE patients. Intervention Patients were randomized 1:1:1 to monthly injections of intravitreal ranibizumab 0.3 or 0.5 mg or sham. Study participants could receive macular laser for DME from month 3 onward if specific criteria were met. Main Outcome Measures: Exploratory post hoc analysis of mean change from baseline in NEI VFQ-25 scores at 12 and 24 months. Results: Across all treatment arms, 13% to 28% of enrolled eyes were the better-seeing eye. For all eyes in RIDE and RISE, the mean change in NEI VFQ-25 composite score improved more in ranibizumab-treated eyes at both the 12- and 24-month visits compared with sham treatment. For the better-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 10.9 more (95% confidence interval [CI], 2.5-19.2) than sham for RIDE patients and 1.3 more (95% CI, -10.5 to 13.0) than sham for RISE patients. For the worse-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 1.0 more (95% CI, -4.7 to 6.7) than sham for RIDE patients and 1.8 more (95% CI, -2.7 to 6.2) than sham for RISE patients. Similar results for most of these outcomes were seen with 0.5 mg ranibizumab. Conclusions: These phase 3 trials demonstrated that ranibizumab treatment for DME likely improves patient-reported vision-related function outcomes compared with sham, further supporting treatment of DME with ranibizumab.

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