Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy

Patient-Centered Outcomes From a Randomized Clinical Trial

Wesley T. Beaulieu, Neil M Bressler, Michele Melia, Cynthia Owsley, Calvin E. Mein, Jeffrey G. Gross, Lee M. Jampol, Adam R. Glassman

Research output: Contribution to journalArticle

Abstract

Purpose To compare patient-centered outcomes in patients with proliferative diabetic retinopathy (PDR) treated with ranibizumab vs panretinal photocoagulation (PRP). Design Randomized clinical trial. Methods SETTING: Multicenter (55 U.S. sites). PATIENT POPULATION: Total of 216 adults with 1 study eye out of 305 adults (excluding participants with 2 study eyes, because each eye received a different treatment) with PDR, visual acuity 20/320 or better, no history of PRP. INTERVENTION: Ranibizumab (0.5 mg/0.05 mL) vs PRP. MAIN OUTCOME MEASURES: Change from baseline to 2 years in composite and prespecified subscale scores from the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), University of Alabama Low Luminance Questionnaire (UAB-LLQ), and Work Productivity and Activity Impairment Questionnaire (WPAIQ). Results For the NEI VFQ-25 and UAB-LLQ composite scores, ranibizumab–PRP treatment group differences (95% CI) were +4.0 (-0.2, +8.3, P =.06) and +1.8 (-3.5, +7.1, P = 0.51) at 1 year, and +2.9 (-1.5, +7.2, P =.20) and +2.3 (-2.9, +7.5, P = .37) at 2 years, respectively. Work productivity loss measured with the WPAIQ was 15.6% less with ranibizumab (-26.3%, −4.8%, P =.005) at 1 year and 2.9% (-12.2%, +6.4%, P =.54) at 2 years. Eighty-three ranibizumab participants (97%) were 20/40 or better in at least 1 eye (visual acuity requirement to qualify for an unrestricted driver's license in many states) at 2 years compared with 82 PRP participants (87%, adjusted risk ratio = 1.1, 95% CI: 1.0, 1.2, P =.005). Conclusions Though differences in some work productivity and driving-related outcomes favored ranibizumab over PRP, no differences between treatment regimens for PDR were identified for most of the other patient-centered outcomes considered.

Original languageEnglish (US)
Pages (from-to)i
JournalAmerican Journal of Ophthalmology
Volume170
DOIs
StatePublished - Oct 1 2016

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Light Coagulation
Diabetic Retinopathy
Randomized Controlled Trials
National Eye Institute (U.S.)
Visual Acuity
Licensure
Ranibizumab
Surveys and Questionnaires
Therapeutics
Odds Ratio

ASJC Scopus subject areas

  • Ophthalmology

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Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy : Patient-Centered Outcomes From a Randomized Clinical Trial. / Beaulieu, Wesley T.; Bressler, Neil M; Melia, Michele; Owsley, Cynthia; Mein, Calvin E.; Gross, Jeffrey G.; Jampol, Lee M.; Glassman, Adam R.

In: American Journal of Ophthalmology, Vol. 170, 01.10.2016, p. i.

Research output: Contribution to journalArticle

Beaulieu, Wesley T. ; Bressler, Neil M ; Melia, Michele ; Owsley, Cynthia ; Mein, Calvin E. ; Gross, Jeffrey G. ; Jampol, Lee M. ; Glassman, Adam R. / Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy : Patient-Centered Outcomes From a Randomized Clinical Trial. In: American Journal of Ophthalmology. 2016 ; Vol. 170. pp. i.
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abstract = "Purpose To compare patient-centered outcomes in patients with proliferative diabetic retinopathy (PDR) treated with ranibizumab vs panretinal photocoagulation (PRP). Design Randomized clinical trial. Methods SETTING: Multicenter (55 U.S. sites). PATIENT POPULATION: Total of 216 adults with 1 study eye out of 305 adults (excluding participants with 2 study eyes, because each eye received a different treatment) with PDR, visual acuity 20/320 or better, no history of PRP. INTERVENTION: Ranibizumab (0.5 mg/0.05 mL) vs PRP. MAIN OUTCOME MEASURES: Change from baseline to 2 years in composite and prespecified subscale scores from the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), University of Alabama Low Luminance Questionnaire (UAB-LLQ), and Work Productivity and Activity Impairment Questionnaire (WPAIQ). Results For the NEI VFQ-25 and UAB-LLQ composite scores, ranibizumab–PRP treatment group differences (95{\%} CI) were +4.0 (-0.2, +8.3, P =.06) and +1.8 (-3.5, +7.1, P = 0.51) at 1 year, and +2.9 (-1.5, +7.2, P =.20) and +2.3 (-2.9, +7.5, P = .37) at 2 years, respectively. Work productivity loss measured with the WPAIQ was 15.6{\%} less with ranibizumab (-26.3{\%}, −4.8{\%}, P =.005) at 1 year and 2.9{\%} (-12.2{\%}, +6.4{\%}, P =.54) at 2 years. Eighty-three ranibizumab participants (97{\%}) were 20/40 or better in at least 1 eye (visual acuity requirement to qualify for an unrestricted driver's license in many states) at 2 years compared with 82 PRP participants (87{\%}, adjusted risk ratio = 1.1, 95{\%} CI: 1.0, 1.2, P =.005). Conclusions Though differences in some work productivity and driving-related outcomes favored ranibizumab over PRP, no differences between treatment regimens for PDR were identified for most of the other patient-centered outcomes considered.",
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T2 - Patient-Centered Outcomes From a Randomized Clinical Trial

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AU - Bressler, Neil M

AU - Melia, Michele

AU - Owsley, Cynthia

AU - Mein, Calvin E.

AU - Gross, Jeffrey G.

AU - Jampol, Lee M.

AU - Glassman, Adam R.

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N2 - Purpose To compare patient-centered outcomes in patients with proliferative diabetic retinopathy (PDR) treated with ranibizumab vs panretinal photocoagulation (PRP). Design Randomized clinical trial. Methods SETTING: Multicenter (55 U.S. sites). PATIENT POPULATION: Total of 216 adults with 1 study eye out of 305 adults (excluding participants with 2 study eyes, because each eye received a different treatment) with PDR, visual acuity 20/320 or better, no history of PRP. INTERVENTION: Ranibizumab (0.5 mg/0.05 mL) vs PRP. MAIN OUTCOME MEASURES: Change from baseline to 2 years in composite and prespecified subscale scores from the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), University of Alabama Low Luminance Questionnaire (UAB-LLQ), and Work Productivity and Activity Impairment Questionnaire (WPAIQ). Results For the NEI VFQ-25 and UAB-LLQ composite scores, ranibizumab–PRP treatment group differences (95% CI) were +4.0 (-0.2, +8.3, P =.06) and +1.8 (-3.5, +7.1, P = 0.51) at 1 year, and +2.9 (-1.5, +7.2, P =.20) and +2.3 (-2.9, +7.5, P = .37) at 2 years, respectively. Work productivity loss measured with the WPAIQ was 15.6% less with ranibizumab (-26.3%, −4.8%, P =.005) at 1 year and 2.9% (-12.2%, +6.4%, P =.54) at 2 years. Eighty-three ranibizumab participants (97%) were 20/40 or better in at least 1 eye (visual acuity requirement to qualify for an unrestricted driver's license in many states) at 2 years compared with 82 PRP participants (87%, adjusted risk ratio = 1.1, 95% CI: 1.0, 1.2, P =.005). Conclusions Though differences in some work productivity and driving-related outcomes favored ranibizumab over PRP, no differences between treatment regimens for PDR were identified for most of the other patient-centered outcomes considered.

AB - Purpose To compare patient-centered outcomes in patients with proliferative diabetic retinopathy (PDR) treated with ranibizumab vs panretinal photocoagulation (PRP). Design Randomized clinical trial. Methods SETTING: Multicenter (55 U.S. sites). PATIENT POPULATION: Total of 216 adults with 1 study eye out of 305 adults (excluding participants with 2 study eyes, because each eye received a different treatment) with PDR, visual acuity 20/320 or better, no history of PRP. INTERVENTION: Ranibizumab (0.5 mg/0.05 mL) vs PRP. MAIN OUTCOME MEASURES: Change from baseline to 2 years in composite and prespecified subscale scores from the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), University of Alabama Low Luminance Questionnaire (UAB-LLQ), and Work Productivity and Activity Impairment Questionnaire (WPAIQ). Results For the NEI VFQ-25 and UAB-LLQ composite scores, ranibizumab–PRP treatment group differences (95% CI) were +4.0 (-0.2, +8.3, P =.06) and +1.8 (-3.5, +7.1, P = 0.51) at 1 year, and +2.9 (-1.5, +7.2, P =.20) and +2.3 (-2.9, +7.5, P = .37) at 2 years, respectively. Work productivity loss measured with the WPAIQ was 15.6% less with ranibizumab (-26.3%, −4.8%, P =.005) at 1 year and 2.9% (-12.2%, +6.4%, P =.54) at 2 years. Eighty-three ranibizumab participants (97%) were 20/40 or better in at least 1 eye (visual acuity requirement to qualify for an unrestricted driver's license in many states) at 2 years compared with 82 PRP participants (87%, adjusted risk ratio = 1.1, 95% CI: 1.0, 1.2, P =.005). Conclusions Though differences in some work productivity and driving-related outcomes favored ranibizumab over PRP, no differences between treatment regimens for PDR were identified for most of the other patient-centered outcomes considered.

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