Twenty-four–Month Outcomes of the Ranibizumab for Edema of the Macula in Diabetes – Protocol 3 with High Dose (READ-3) Study

Yasir J. Sepah, Mohammad Ali Sadiq, David Boyer, David Callanan, Ron Gallemore, Michael Bennett, Dennis Marcus, Lawrence Halperin, Muhammad Hassan, Peter A. Campochiaro, Quan Dong Nguyen, Diana V. Do, Diana V Do, Erik Kruger, John Pollack, Kang Zhang, Andrew Symons, Prema Abraham, Brian P. Conway, David J. Wilson & 4 others Mostafa Hanout, Aniruddha Agarwal, Rubbia Afridi, Quan Dong Nguyen

Research output: Contribution to journalArticle

10 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). Design Randomized, controlled, double-masked (to the dose), interventional, multicenter clinical trial. Participants A total of 152 patients (152 eyes) with DME. Methods Eligible 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 mandatory injections followed by as-needed injections until month 24. Main Outcome Measures The primary efficacy end point of the study was mean change in best-corrected visual acuity (BCVA) and central foveal thickness (CFT) at month 6. Secondary outcomes included the mean change in BCVA and CFT at month 24, and incidence and severity of systemic and ocular adverse events through month 24. Results A total of 152 eyes were randomized in the study. At month 24, the mean improvement from baseline BCVA was +11.06 letters in the 0.5 mg RBZ group (n = 59) and +6.78 letters in the 2.0 mg RBZ group (n = 54) (P = 0.02). The mean numbers of RBZ injections through month 24 were 18.4 and 17.3 in the 0.5 mg and 2.0 mg RBZ groups, respectively (P = 0.08). The mean change in CFT was −192.53 μm in the 0.5 mg RBZ group and −170.64 μm in the 2.0 mg RBZ group (P = 0.41). By month 24, 3 deaths had occurred in the 0.5 mg RBZ group and 3 deaths had occurred in the 2.0 mg RBZ group; 5 of these 6 deaths occurred secondary to cardiovascular causes, and 1 death occurred as the result of severe pneumonia. All 5 patients with a cardiovascular cause of death had a history of coronary heart disease. Conclusions At month 24, there were significant visual and anatomic improvements in both groups, with subjects in the 0.5 mg RBZ group gaining more vision. Visual and anatomic gains achieved at month 6 were largely maintained through month 24. No new safety events were identified. In this study population, 2.0 mg RBZ does not appear to provide additional benefit over 0.5 mg RBZ.

Original languageEnglish (US)
Pages (from-to)2581-2587
Number of pages7
JournalOphthalmology
Volume123
Issue number12
DOIs
StatePublished - Dec 1 2016

Fingerprint

Edema
Visual Acuity
Injections
Macular Edema
Ranibizumab
Cause of Death
Multicenter Studies
Coronary Disease
Pneumonia
Outcome Assessment (Health Care)
Clinical Trials
Safety

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Sepah, Y. J., Sadiq, M. A., Boyer, D., Callanan, D., Gallemore, R., Bennett, M., ... Nguyen, Q. D. (2016). Twenty-four–Month Outcomes of the Ranibizumab for Edema of the Macula in Diabetes – Protocol 3 with High Dose (READ-3) Study. Ophthalmology, 123(12), 2581-2587. https://doi.org/10.1016/j.ophtha.2016.08.040

Twenty-four–Month Outcomes of the Ranibizumab for Edema of the Macula in Diabetes – Protocol 3 with High Dose (READ-3) Study. / Sepah, Yasir J.; Sadiq, Mohammad Ali; Boyer, David; Callanan, David; Gallemore, Ron; Bennett, Michael; Marcus, Dennis; Halperin, Lawrence; Hassan, Muhammad; Campochiaro, Peter A.; Nguyen, Quan Dong; Do, Diana V.; Do, Diana V; Kruger, Erik; Pollack, John; Zhang, Kang; Symons, Andrew; Abraham, Prema; Conway, Brian P.; Wilson, David J.; Hanout, Mostafa; Agarwal, Aniruddha; Afridi, Rubbia; Nguyen, Quan Dong.

In: Ophthalmology, Vol. 123, No. 12, 01.12.2016, p. 2581-2587.

Research output: Contribution to journalArticle

Sepah, YJ, Sadiq, MA, Boyer, D, Callanan, D, Gallemore, R, Bennett, M, Marcus, D, Halperin, L, Hassan, M, Campochiaro, PA, Nguyen, QD, Do, DV, Do, DV, Kruger, E, Pollack, J, Zhang, K, Symons, A, Abraham, P, Conway, BP, Wilson, DJ, Hanout, M, Agarwal, A, Afridi, R & Nguyen, QD 2016, 'Twenty-four–Month Outcomes of the Ranibizumab for Edema of the Macula in Diabetes – Protocol 3 with High Dose (READ-3) Study', Ophthalmology, vol. 123, no. 12, pp. 2581-2587. https://doi.org/10.1016/j.ophtha.2016.08.040
Sepah, Yasir J. ; Sadiq, Mohammad Ali ; Boyer, David ; Callanan, David ; Gallemore, Ron ; Bennett, Michael ; Marcus, Dennis ; Halperin, Lawrence ; Hassan, Muhammad ; Campochiaro, Peter A. ; Nguyen, Quan Dong ; Do, Diana V. ; Do, Diana V ; Kruger, Erik ; Pollack, John ; Zhang, Kang ; Symons, Andrew ; Abraham, Prema ; Conway, Brian P. ; Wilson, David J. ; Hanout, Mostafa ; Agarwal, Aniruddha ; Afridi, Rubbia ; Nguyen, Quan Dong. / Twenty-four–Month Outcomes of the Ranibizumab for Edema of the Macula in Diabetes – Protocol 3 with High Dose (READ-3) Study. In: Ophthalmology. 2016 ; Vol. 123, No. 12. pp. 2581-2587.
@article{7fe8d91093694570a583399ba12b2684,
title = "Twenty-four–Month Outcomes of the Ranibizumab for Edema of the Macula in Diabetes – Protocol 3 with High Dose (READ-3) Study",
abstract = "Purpose To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME). Design Randomized, controlled, double-masked (to the dose), interventional, multicenter clinical trial. Participants A total of 152 patients (152 eyes) with DME. Methods Eligible 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 mandatory injections followed by as-needed injections until month 24. Main Outcome Measures The primary efficacy end point of the study was mean change in best-corrected visual acuity (BCVA) and central foveal thickness (CFT) at month 6. Secondary outcomes included the mean change in BCVA and CFT at month 24, and incidence and severity of systemic and ocular adverse events through month 24. Results A total of 152 eyes were randomized in the study. At month 24, the mean improvement from baseline BCVA was +11.06 letters in the 0.5 mg RBZ group (n = 59) and +6.78 letters in the 2.0 mg RBZ group (n = 54) (P = 0.02). The mean numbers of RBZ injections through month 24 were 18.4 and 17.3 in the 0.5 mg and 2.0 mg RBZ groups, respectively (P = 0.08). The mean change in CFT was −192.53 μm in the 0.5 mg RBZ group and −170.64 μm in the 2.0 mg RBZ group (P = 0.41). By month 24, 3 deaths had occurred in the 0.5 mg RBZ group and 3 deaths had occurred in the 2.0 mg RBZ group; 5 of these 6 deaths occurred secondary to cardiovascular causes, and 1 death occurred as the result of severe pneumonia. All 5 patients with a cardiovascular cause of death had a history of coronary heart disease. Conclusions At month 24, there were significant visual and anatomic improvements in both groups, with subjects in the 0.5 mg RBZ group gaining more vision. Visual and anatomic gains achieved at month 6 were largely maintained through month 24. No new safety events were identified. In this study population, 2.0 mg RBZ does not appear to provide additional benefit over 0.5 mg RBZ.",
author = "Sepah, {Yasir J.} and Sadiq, {Mohammad Ali} and David Boyer and David Callanan and Ron Gallemore and Michael Bennett and Dennis Marcus and Lawrence Halperin and Muhammad Hassan and Campochiaro, {Peter A.} and Nguyen, {Quan Dong} and Do, {Diana V.} and Do, {Diana V} and Erik Kruger and John Pollack and Kang Zhang and Andrew Symons and Prema Abraham and Conway, {Brian P.} and Wilson, {David J.} and Mostafa Hanout and Aniruddha Agarwal and Rubbia Afridi and Nguyen, {Quan Dong}",
year = "2016",
month = "12",
day = "1",
doi = "10.1016/j.ophtha.2016.08.040",
language = "English (US)",
volume = "123",
pages = "2581--2587",
journal = "Ophthalmology",
issn = "0161-6420",
publisher = "Elsevier Inc.",
number = "12",

}

TY - JOUR

T1 - Twenty-four–Month Outcomes of the Ranibizumab for Edema of the Macula in Diabetes – Protocol 3 with High Dose (READ-3) Study

AU - Sepah, Yasir J.

AU - Sadiq, Mohammad Ali

AU - Boyer, David

AU - Callanan, David

AU - Gallemore, Ron

AU - Bennett, Michael

AU - Marcus, Dennis

AU - Halperin, Lawrence

AU - Hassan, Muhammad

AU - Campochiaro, Peter A.

AU - Nguyen, Quan Dong

AU - Do, Diana V.

AU - Do, Diana V

AU - Kruger, Erik

AU - Pollack, John

AU - Zhang, Kang

AU - Symons, Andrew

AU - Abraham, Prema

AU - Conway, Brian P.

AU - Wilson, David J.

AU - Hanout, Mostafa

AU - Agarwal, Aniruddha

AU - Afridi, Rubbia

AU - Nguyen, Quan Dong

PY - 2016/12/1

Y1 - 2016/12/1

N2 - Purpose To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME). Design Randomized, controlled, double-masked (to the dose), interventional, multicenter clinical trial. Participants A total of 152 patients (152 eyes) with DME. Methods Eligible 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 mandatory injections followed by as-needed injections until month 24. Main Outcome Measures The primary efficacy end point of the study was mean change in best-corrected visual acuity (BCVA) and central foveal thickness (CFT) at month 6. Secondary outcomes included the mean change in BCVA and CFT at month 24, and incidence and severity of systemic and ocular adverse events through month 24. Results A total of 152 eyes were randomized in the study. At month 24, the mean improvement from baseline BCVA was +11.06 letters in the 0.5 mg RBZ group (n = 59) and +6.78 letters in the 2.0 mg RBZ group (n = 54) (P = 0.02). The mean numbers of RBZ injections through month 24 were 18.4 and 17.3 in the 0.5 mg and 2.0 mg RBZ groups, respectively (P = 0.08). The mean change in CFT was −192.53 μm in the 0.5 mg RBZ group and −170.64 μm in the 2.0 mg RBZ group (P = 0.41). By month 24, 3 deaths had occurred in the 0.5 mg RBZ group and 3 deaths had occurred in the 2.0 mg RBZ group; 5 of these 6 deaths occurred secondary to cardiovascular causes, and 1 death occurred as the result of severe pneumonia. All 5 patients with a cardiovascular cause of death had a history of coronary heart disease. Conclusions At month 24, there were significant visual and anatomic improvements in both groups, with subjects in the 0.5 mg RBZ group gaining more vision. Visual and anatomic gains achieved at month 6 were largely maintained through month 24. No new safety events were identified. In this study population, 2.0 mg 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). Design Randomized, controlled, double-masked (to the dose), interventional, multicenter clinical trial. Participants A total of 152 patients (152 eyes) with DME. Methods Eligible 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 mandatory injections followed by as-needed injections until month 24. Main Outcome Measures The primary efficacy end point of the study was mean change in best-corrected visual acuity (BCVA) and central foveal thickness (CFT) at month 6. Secondary outcomes included the mean change in BCVA and CFT at month 24, and incidence and severity of systemic and ocular adverse events through month 24. Results A total of 152 eyes were randomized in the study. At month 24, the mean improvement from baseline BCVA was +11.06 letters in the 0.5 mg RBZ group (n = 59) and +6.78 letters in the 2.0 mg RBZ group (n = 54) (P = 0.02). The mean numbers of RBZ injections through month 24 were 18.4 and 17.3 in the 0.5 mg and 2.0 mg RBZ groups, respectively (P = 0.08). The mean change in CFT was −192.53 μm in the 0.5 mg RBZ group and −170.64 μm in the 2.0 mg RBZ group (P = 0.41). By month 24, 3 deaths had occurred in the 0.5 mg RBZ group and 3 deaths had occurred in the 2.0 mg RBZ group; 5 of these 6 deaths occurred secondary to cardiovascular causes, and 1 death occurred as the result of severe pneumonia. All 5 patients with a cardiovascular cause of death had a history of coronary heart disease. Conclusions At month 24, there were significant visual and anatomic improvements in both groups, with subjects in the 0.5 mg RBZ group gaining more vision. Visual and anatomic gains achieved at month 6 were largely maintained through month 24. No new safety events were identified. In this study population, 2.0 mg RBZ does not appear to provide additional benefit over 0.5 mg RBZ.

UR - http://www.scopus.com/inward/record.url?scp=84996569812&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84996569812&partnerID=8YFLogxK

U2 - 10.1016/j.ophtha.2016.08.040

DO - 10.1016/j.ophtha.2016.08.040

M3 - Article

VL - 123

SP - 2581

EP - 2587

JO - Ophthalmology

JF - Ophthalmology

SN - 0161-6420

IS - 12

ER -