PRAGMATISM OF RANDOMIZED CLINICAL TRIALS ON RANIBIZUMAB FOR THE TREATMENT OF DIABETIC MACULAR EDEMA: Impact on Clinical Outcomes.

Retina
Stephen StewartNoemi Lois

Abstract

To evaluate the pragmatism and generalizability of randomized clinical trials (RCTs) on ranibizumab for diabetic macular edema and determine whether clinical outcomes would differ based on whether or not patients fulfill the eligibility criteria of these RCTs. Pragmatism and generalizability of three RCTs on ranibizumab for diabetic macular edema (DRCRnet Protocols I and T, and RESTORE) were rated using the PRECIS-2 tool. A cohort of consecutive patients with diabetic macular edema was assessed to determine whether clinical outcomes differed based on whether or not patients met the RCT eligibility criteria. Univariable and multivariable regression analyses, adjusted for baseline best-corrected visual acuity, central retinal thickness and number of injections received, were used. All RCTs were rated as being more pragmatic than explanatory, with DRCRnet trials being the most pragmatic. Of the 216 eyes (176 patients) included in the cohort, 63% would have met eligibility criteria for Protocol T, 61% for Protocol I, and 56% for RESTORE. When adjusted for best-corrected visual acuity, central retinal thickness, and number of ranibizumab injections received, there were no statistically significant differences in best-corrected visua...Continue Reading

References

Aug 1, 1967·Journal of Chronic Diseases·D Schwartz, J Lellouch
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Sep 22, 2010·Ophthalmology·Quan Dong NguyenUNKNOWN READ-2 Study Group
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Feb 19, 2015·The New England Journal of Medicine·UNKNOWN Diabetic Retinopathy Clinical Research NetworkRoy W Beck
Jun 13, 2017·Journal of Clinical Epidemiology·Kirsty LoudonShaun Treweek

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Software Mentioned

DRCRnet
Stata
PRECIS

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