Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes-Protocol 3 with high dose)

D. V. Do, Y. J. Sepah, D. Boyer, D. Callanan, R. Gallemore, M. Bennett, D. M. Marcus, L. Halperin, M. A. Sadiq, N. Rajagopalan, P. A. Campochiaro, Q. D. Nguyen

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Purpose To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME) and a central subfield thickness (CFT) of ≥250 μm on time-domain optical coherence tomography.Design Randomized, controlled, multicenter clinical trial.MethodsEligible eyes were randomized in a 1:1 ratio to 0.5 mg (n=77) or 2.0 mg (n=75) RBZ. Study eyes received 6-monthly injections.Main outcome measuresThe primary outcome measure was the mean change in best corrected visual acuity (BCVA) at month 6. Secondary outcomes included the incidence and severity of systemic and ocular adverse events and the mean change in CFT from baseline.ResultsIn all, 152 eyes (152 patients) were randomized in the study. At month 6, the mean improvement from baseline BCVA was +9.43 letters in the 0.5 mg RBZ group and +7.01 letters in the 2.0 mg RBZ group (P=0.161). At month 6, one death occurred in the 0.5 mg RBZ group and three deaths in the 2.0 mg RBZ group, all due to myocardial infarction in subjects with a prior history of heart disease. Mean CFT was reduced by 168.58 μm in the 0.5 mg RBZ group and by 159.70 μm in the 2.0 mg RBZ group (P=0.708).ConclusionsThere was no statistically significant difference in the mean number of letters gained between the 0.5 and 2.0 mg RBZ groups through month 6. In this DME study population, high-dose RBZ does not appear to provide additional benefit over 0.5 mg RBZ.

Original languageEnglish (US)
Pages (from-to)1538-1544
Number of pages7
JournalEye (Basingstoke)
Volume29
Issue number12
DOIs
StatePublished - Dec 1 2015

Fingerprint

Edema
Macular Edema
Visual Acuity
Ranibizumab
Injections
Optical Coherence Tomography
Multicenter Studies
Heart Diseases
Randomized Controlled Trials
Myocardial Infarction
Outcome Assessment (Health Care)
Incidence

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems

Cite this

Do, D. V., Sepah, Y. J., Boyer, D., Callanan, D., Gallemore, R., Bennett, M., ... Nguyen, Q. D. (2015). Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes-Protocol 3 with high dose). Eye (Basingstoke), 29(12), 1538-1544. https://doi.org/10.1038/eye.2015.142

Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes-Protocol 3 with high dose). / Do, D. V.; Sepah, Y. J.; Boyer, D.; Callanan, D.; Gallemore, R.; Bennett, M.; Marcus, D. M.; Halperin, L.; Sadiq, M. A.; Rajagopalan, N.; Campochiaro, P. A.; Nguyen, Q. D.

In: Eye (Basingstoke), Vol. 29, No. 12, 01.12.2015, p. 1538-1544.

Research output: Contribution to journalArticle

Do, DV, Sepah, YJ, Boyer, D, Callanan, D, Gallemore, R, Bennett, M, Marcus, DM, Halperin, L, Sadiq, MA, Rajagopalan, N, Campochiaro, PA & Nguyen, QD 2015, 'Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes-Protocol 3 with high dose)', Eye (Basingstoke), vol. 29, no. 12, pp. 1538-1544. https://doi.org/10.1038/eye.2015.142
Do, D. V. ; Sepah, Y. J. ; Boyer, D. ; Callanan, D. ; Gallemore, R. ; Bennett, M. ; Marcus, D. M. ; Halperin, L. ; Sadiq, M. A. ; Rajagopalan, N. ; Campochiaro, P. A. ; Nguyen, Q. D. / Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes-Protocol 3 with high dose). In: Eye (Basingstoke). 2015 ; Vol. 29, No. 12. pp. 1538-1544.
@article{2fd0aee3623640c0961b7f481f9b8d4d,
title = "Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes-Protocol 3 with high dose)",
abstract = "Purpose To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME) and a central subfield thickness (CFT) of ≥250 μm on time-domain optical coherence tomography.Design Randomized, controlled, multicenter clinical trial.MethodsEligible eyes were randomized in a 1:1 ratio to 0.5 mg (n=77) or 2.0 mg (n=75) RBZ. Study eyes received 6-monthly injections.Main outcome measuresThe primary outcome measure was the mean change in best corrected visual acuity (BCVA) at month 6. Secondary outcomes included the incidence and severity of systemic and ocular adverse events and the mean change in CFT from baseline.ResultsIn all, 152 eyes (152 patients) were randomized in the study. At month 6, the mean improvement from baseline BCVA was +9.43 letters in the 0.5 mg RBZ group and +7.01 letters in the 2.0 mg RBZ group (P=0.161). At month 6, one death occurred in the 0.5 mg RBZ group and three deaths in the 2.0 mg RBZ group, all due to myocardial infarction in subjects with a prior history of heart disease. Mean CFT was reduced by 168.58 μm in the 0.5 mg RBZ group and by 159.70 μm in the 2.0 mg RBZ group (P=0.708).ConclusionsThere was no statistically significant difference in the mean number of letters gained between the 0.5 and 2.0 mg RBZ groups through month 6. In this DME study population, high-dose RBZ does not appear to provide additional benefit over 0.5 mg RBZ.",
author = "Do, {D. V.} and Sepah, {Y. J.} and D. Boyer and D. Callanan and R. Gallemore and M. Bennett and Marcus, {D. M.} and L. Halperin and Sadiq, {M. A.} and N. Rajagopalan and Campochiaro, {P. A.} and Nguyen, {Q. D.}",
year = "2015",
month = "12",
day = "1",
doi = "10.1038/eye.2015.142",
language = "English (US)",
volume = "29",
pages = "1538--1544",
journal = "Eye (London, England)",
issn = "0950-222X",
publisher = "Nature Publishing Group",
number = "12",

}

TY - JOUR

T1 - Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes-Protocol 3 with high dose)

AU - Do, D. V.

AU - Sepah, Y. J.

AU - Boyer, D.

AU - Callanan, D.

AU - Gallemore, R.

AU - Bennett, M.

AU - Marcus, D. M.

AU - Halperin, L.

AU - Sadiq, M. A.

AU - Rajagopalan, N.

AU - Campochiaro, P. A.

AU - Nguyen, Q. D.

PY - 2015/12/1

Y1 - 2015/12/1

N2 - Purpose To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME) and a central subfield thickness (CFT) of ≥250 μm on time-domain optical coherence tomography.Design Randomized, controlled, multicenter clinical trial.MethodsEligible eyes were randomized in a 1:1 ratio to 0.5 mg (n=77) or 2.0 mg (n=75) RBZ. Study eyes received 6-monthly injections.Main outcome measuresThe primary outcome measure was the mean change in best corrected visual acuity (BCVA) at month 6. Secondary outcomes included the incidence and severity of systemic and ocular adverse events and the mean change in CFT from baseline.ResultsIn all, 152 eyes (152 patients) were randomized in the study. At month 6, the mean improvement from baseline BCVA was +9.43 letters in the 0.5 mg RBZ group and +7.01 letters in the 2.0 mg RBZ group (P=0.161). At month 6, one death occurred in the 0.5 mg RBZ group and three deaths in the 2.0 mg RBZ group, all due to myocardial infarction in subjects with a prior history of heart disease. Mean CFT was reduced by 168.58 μm in the 0.5 mg RBZ group and by 159.70 μm in the 2.0 mg RBZ group (P=0.708).ConclusionsThere was no statistically significant difference in the mean number of letters gained between the 0.5 and 2.0 mg RBZ groups through month 6. In this DME study population, high-dose RBZ does not appear to provide additional benefit over 0.5 mg RBZ.

AB - Purpose To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME) and a central subfield thickness (CFT) of ≥250 μm on time-domain optical coherence tomography.Design Randomized, controlled, multicenter clinical trial.MethodsEligible eyes were randomized in a 1:1 ratio to 0.5 mg (n=77) or 2.0 mg (n=75) RBZ. Study eyes received 6-monthly injections.Main outcome measuresThe primary outcome measure was the mean change in best corrected visual acuity (BCVA) at month 6. Secondary outcomes included the incidence and severity of systemic and ocular adverse events and the mean change in CFT from baseline.ResultsIn all, 152 eyes (152 patients) were randomized in the study. At month 6, the mean improvement from baseline BCVA was +9.43 letters in the 0.5 mg RBZ group and +7.01 letters in the 2.0 mg RBZ group (P=0.161). At month 6, one death occurred in the 0.5 mg RBZ group and three deaths in the 2.0 mg RBZ group, all due to myocardial infarction in subjects with a prior history of heart disease. Mean CFT was reduced by 168.58 μm in the 0.5 mg RBZ group and by 159.70 μm in the 2.0 mg RBZ group (P=0.708).ConclusionsThere was no statistically significant difference in the mean number of letters gained between the 0.5 and 2.0 mg RBZ groups through month 6. In this DME study population, high-dose RBZ does not appear to provide additional benefit over 0.5 mg RBZ.

UR - http://www.scopus.com/inward/record.url?scp=84949599724&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84949599724&partnerID=8YFLogxK

U2 - 10.1038/eye.2015.142

DO - 10.1038/eye.2015.142

M3 - Article

C2 - 26228291

AN - SCOPUS:84949599724

VL - 29

SP - 1538

EP - 1544

JO - Eye (London, England)

JF - Eye (London, England)

SN - 0950-222X

IS - 12

ER -