Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study

Quan Dong Nguyen, Syed Mahmood Shah, Afsheen A. Khwaja, Roomasa Channa, Elham Hatef, Diana V. Do, David Boyer, Jeffery S. Heier, Prema Abraham, Allen B. Thach, Eugene S. Lit, Bradley S. Foster, Erik Kruger, Pravin Dugel, Thomas Chang, Arup Das, Thomas A. Ciulla, John S. Pollack, Jennifer I. Lim, Dean EliotPeter A. Campochiaro

Research output: Contribution to journalArticle

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Abstract

Objectives To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME). Design Prospective, randomized, interventional, multicenter clinical trial. Participants One hundred twenty-six patients with DME. Methods Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ. Main Outcome Measures The mean change from baseline in best-corrected visual acuity (BCVA) at month 24. Results After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36%, 47%, and 68%, respectively. Conclusions Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.

Original languageEnglish (US)
Pages (from-to)2146-2151
Number of pages6
JournalOphthalmology
Volume117
Issue number11
DOIs
StatePublished - Nov 1 2010

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Edema
Macular Edema
Visual Acuity
Lasers
Disclosure
Ranibizumab
Intraocular Injections
Injections
Retreatment
Light Coagulation
Multicenter Studies
Outcome Assessment (Health Care)
Clinical Trials

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Nguyen, Q. D., Shah, S. M., Khwaja, A. A., Channa, R., Hatef, E., Do, D. V., ... Campochiaro, P. A. (2010). Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. Ophthalmology, 117(11), 2146-2151. https://doi.org/10.1016/j.ophtha.2010.08.016

Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. / Nguyen, Quan Dong; Shah, Syed Mahmood; Khwaja, Afsheen A.; Channa, Roomasa; Hatef, Elham; Do, Diana V.; Boyer, David; Heier, Jeffery S.; Abraham, Prema; Thach, Allen B.; Lit, Eugene S.; Foster, Bradley S.; Kruger, Erik; Dugel, Pravin; Chang, Thomas; Das, Arup; Ciulla, Thomas A.; Pollack, John S.; Lim, Jennifer I.; Eliot, Dean; Campochiaro, Peter A.

In: Ophthalmology, Vol. 117, No. 11, 01.11.2010, p. 2146-2151.

Research output: Contribution to journalArticle

Nguyen, QD, Shah, SM, Khwaja, AA, Channa, R, Hatef, E, Do, DV, Boyer, D, Heier, JS, Abraham, P, Thach, AB, Lit, ES, Foster, BS, Kruger, E, Dugel, P, Chang, T, Das, A, Ciulla, TA, Pollack, JS, Lim, JI, Eliot, D & Campochiaro, PA 2010, 'Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study', Ophthalmology, vol. 117, no. 11, pp. 2146-2151. https://doi.org/10.1016/j.ophtha.2010.08.016
Nguyen QD, Shah SM, Khwaja AA, Channa R, Hatef E, Do DV et al. Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. Ophthalmology. 2010 Nov 1;117(11):2146-2151. https://doi.org/10.1016/j.ophtha.2010.08.016
Nguyen, Quan Dong ; Shah, Syed Mahmood ; Khwaja, Afsheen A. ; Channa, Roomasa ; Hatef, Elham ; Do, Diana V. ; Boyer, David ; Heier, Jeffery S. ; Abraham, Prema ; Thach, Allen B. ; Lit, Eugene S. ; Foster, Bradley S. ; Kruger, Erik ; Dugel, Pravin ; Chang, Thomas ; Das, Arup ; Ciulla, Thomas A. ; Pollack, John S. ; Lim, Jennifer I. ; Eliot, Dean ; Campochiaro, Peter A. / Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. In: Ophthalmology. 2010 ; Vol. 117, No. 11. pp. 2146-2151.
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abstract = "Objectives To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME). Design Prospective, randomized, interventional, multicenter clinical trial. Participants One hundred twenty-six patients with DME. Methods Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ. Main Outcome Measures The mean change from baseline in best-corrected visual acuity (BCVA) at month 24. Results After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45{\%} in group 1, 44{\%} in group 2, and 35{\%} in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36{\%}, 47{\%}, and 68{\%}, respectively. Conclusions Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.",
author = "Nguyen, {Quan Dong} and Shah, {Syed Mahmood} and Khwaja, {Afsheen A.} and Roomasa Channa and Elham Hatef and Do, {Diana V.} and David Boyer and Heier, {Jeffery S.} and Prema Abraham and Thach, {Allen B.} and Lit, {Eugene S.} and Foster, {Bradley S.} and Erik Kruger and Pravin Dugel and Thomas Chang and Arup Das and Ciulla, {Thomas A.} and Pollack, {John S.} and Lim, {Jennifer I.} and Dean Eliot and Campochiaro, {Peter A.}",
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TY - JOUR

T1 - Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study

AU - Nguyen, Quan Dong

AU - Shah, Syed Mahmood

AU - Khwaja, Afsheen A.

AU - Channa, Roomasa

AU - Hatef, Elham

AU - Do, Diana V.

AU - Boyer, David

AU - Heier, Jeffery S.

AU - Abraham, Prema

AU - Thach, Allen B.

AU - Lit, Eugene S.

AU - Foster, Bradley S.

AU - Kruger, Erik

AU - Dugel, Pravin

AU - Chang, Thomas

AU - Das, Arup

AU - Ciulla, Thomas A.

AU - Pollack, John S.

AU - Lim, Jennifer I.

AU - Eliot, Dean

AU - Campochiaro, Peter A.

PY - 2010/11/1

Y1 - 2010/11/1

N2 - Objectives To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME). Design Prospective, randomized, interventional, multicenter clinical trial. Participants One hundred twenty-six patients with DME. Methods Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ. Main Outcome Measures The mean change from baseline in best-corrected visual acuity (BCVA) at month 24. Results After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36%, 47%, and 68%, respectively. Conclusions Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.

AB - Objectives To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME). Design Prospective, randomized, interventional, multicenter clinical trial. Participants One hundred twenty-six patients with DME. Methods Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ. Main Outcome Measures The mean change from baseline in best-corrected visual acuity (BCVA) at month 24. Results After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36%, 47%, and 68%, respectively. Conclusions Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.

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