Scatter Photocoagulation Does Not Reduce Macular Edema or Treatment Burden in Patients with Retinal Vein Occlusion

The RELATE Trial

Peter A Campochiaro, Gulnar Hafiz, Tahreem A. Mir, Adrienne Scott, Sharon Solomon, Ingrid E Zimmer Galler, Akrit Sodhi, Elia J Duh, Howard Ying, Adam Wenick, Syed Mahmood Shah, Diana V. Do, Quan D. Nguyen, Saleema Kherani, Raafay Sophie

Research output: Contribution to journalArticle

Abstract

Purpose To determine whether scatter and grid laser photocoagulation (laser) adds benefit to ranibizumab injections in patients with macular edema from retinal vein occlusion (RVO) and to compare 0.5-mg with 2.0-mg ranibizumab. Design Randomized, double-masked, controlled clinical trial. Participants Thirty-nine patients with central RVO (CRVO) and 42 with branch RVO (BRVO). Methods Subjects were randomized to 0.5 mg or 2.0 mg ranibizumab every 4 weeks for 24 weeks and re-randomized to pro re nata ranibizumab plus laser or ranibizumab alone. Main Outcome Measures Mean change from baseline best-corrected visual acuity (BCVA) at week 24 for BCVA at weeks 48, 96, and 144 for second randomization. Results Mean improvement from baseline BCVA at week 24 was 15.5 and 15.8 letters in the 0.5-mg and 2.0-mg CRVO groups, and 12.1 and 14.6 letters in the 0.5-mg and 2.0-mg BRVO groups. For CRVO, but not BRVO, there was significantly greater reduction from baseline mean central subfield thickness (CST) in the 2.0-mg versus 0.5-mg group (396.1 vs. 253.5 μm; P = 0.03). For the second randomization in CRVO patients, there was no significant difference from week 24 BCVA in the ranibizumab plus laser versus the ranibizumab only groups at week 48 (-3.3 vs. 0.0 letters), week 96 (+0.69 vs. -1.6 letters), or week 144 (+0.4 vs. -6.7 letters), and a significant increase from week 24 mean CST at week 48 (+94.7 vs. +15.2 μm; P = 0.05) but not weeks 96 or 144. For BRVO, there was a significant reduction from week 24 mean BCVA in ranibizumab plus laser versus ranibizumab at week 48 (-7.5 vs. +2.8; P <0.01) and week 96 (-2.0 vs. +4.8; P <0.03), but not week 144, and there were no differences in mean CST change from week 24 at weeks 48, 96, or 144. Laser failed to increase edema resolution or to reduce the ranibizumab injections between weeks 24 and 144. Conclusions In patients with macular edema resulting from RVO, there was no short-term clinically significant benefit from monthly injections of 2.0-mg versus 0.5-mg ranibizumab injections and no long-term benefit in BCVA, resolution of edema, or number of ranibizumab injections obtained by addition of laser treatment to ranibizumab.

Original languageEnglish (US)
Article number8622
Pages (from-to)1426-1437
Number of pages12
JournalOphthalmology
Volume122
Issue number7
DOIs
StatePublished - Jul 1 2015

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Retinal Vein Occlusion
Macular Edema
Light Coagulation
Lasers
Visual Acuity
Therapeutics
Injections
Random Allocation
Ranibizumab
Edema
Retinal Vein
Controlled Clinical Trials

ASJC Scopus subject areas

  • Ophthalmology
  • Medicine(all)

Cite this

Scatter Photocoagulation Does Not Reduce Macular Edema or Treatment Burden in Patients with Retinal Vein Occlusion : The RELATE Trial. / Campochiaro, Peter A; Hafiz, Gulnar; Mir, Tahreem A.; Scott, Adrienne; Solomon, Sharon; Zimmer Galler, Ingrid E; Sodhi, Akrit; Duh, Elia J; Ying, Howard; Wenick, Adam; Shah, Syed Mahmood; Do, Diana V.; Nguyen, Quan D.; Kherani, Saleema; Sophie, Raafay.

In: Ophthalmology, Vol. 122, No. 7, 8622, 01.07.2015, p. 1426-1437.

Research output: Contribution to journalArticle

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abstract = "Purpose To determine whether scatter and grid laser photocoagulation (laser) adds benefit to ranibizumab injections in patients with macular edema from retinal vein occlusion (RVO) and to compare 0.5-mg with 2.0-mg ranibizumab. Design Randomized, double-masked, controlled clinical trial. Participants Thirty-nine patients with central RVO (CRVO) and 42 with branch RVO (BRVO). Methods Subjects were randomized to 0.5 mg or 2.0 mg ranibizumab every 4 weeks for 24 weeks and re-randomized to pro re nata ranibizumab plus laser or ranibizumab alone. Main Outcome Measures Mean change from baseline best-corrected visual acuity (BCVA) at week 24 for BCVA at weeks 48, 96, and 144 for second randomization. Results Mean improvement from baseline BCVA at week 24 was 15.5 and 15.8 letters in the 0.5-mg and 2.0-mg CRVO groups, and 12.1 and 14.6 letters in the 0.5-mg and 2.0-mg BRVO groups. For CRVO, but not BRVO, there was significantly greater reduction from baseline mean central subfield thickness (CST) in the 2.0-mg versus 0.5-mg group (396.1 vs. 253.5 μm; P = 0.03). For the second randomization in CRVO patients, there was no significant difference from week 24 BCVA in the ranibizumab plus laser versus the ranibizumab only groups at week 48 (-3.3 vs. 0.0 letters), week 96 (+0.69 vs. -1.6 letters), or week 144 (+0.4 vs. -6.7 letters), and a significant increase from week 24 mean CST at week 48 (+94.7 vs. +15.2 μm; P = 0.05) but not weeks 96 or 144. For BRVO, there was a significant reduction from week 24 mean BCVA in ranibizumab plus laser versus ranibizumab at week 48 (-7.5 vs. +2.8; P <0.01) and week 96 (-2.0 vs. +4.8; P <0.03), but not week 144, and there were no differences in mean CST change from week 24 at weeks 48, 96, or 144. Laser failed to increase edema resolution or to reduce the ranibizumab injections between weeks 24 and 144. Conclusions In patients with macular edema resulting from RVO, there was no short-term clinically significant benefit from monthly injections of 2.0-mg versus 0.5-mg ranibizumab injections and no long-term benefit in BCVA, resolution of edema, or number of ranibizumab injections obtained by addition of laser treatment to ranibizumab.",
author = "Campochiaro, {Peter A} and Gulnar Hafiz and Mir, {Tahreem A.} and Adrienne Scott and Sharon Solomon and {Zimmer Galler}, {Ingrid E} and Akrit Sodhi and Duh, {Elia J} and Howard Ying and Adam Wenick and Shah, {Syed Mahmood} and Do, {Diana V.} and Nguyen, {Quan D.} and Saleema Kherani and Raafay Sophie",
year = "2015",
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doi = "10.1016/j.ophtha.2015.04.006",
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T1 - Scatter Photocoagulation Does Not Reduce Macular Edema or Treatment Burden in Patients with Retinal Vein Occlusion

T2 - The RELATE Trial

AU - Campochiaro, Peter A

AU - Hafiz, Gulnar

AU - Mir, Tahreem A.

AU - Scott, Adrienne

AU - Solomon, Sharon

AU - Zimmer Galler, Ingrid E

AU - Sodhi, Akrit

AU - Duh, Elia J

AU - Ying, Howard

AU - Wenick, Adam

AU - Shah, Syed Mahmood

AU - Do, Diana V.

AU - Nguyen, Quan D.

AU - Kherani, Saleema

AU - Sophie, Raafay

PY - 2015/7/1

Y1 - 2015/7/1

N2 - Purpose To determine whether scatter and grid laser photocoagulation (laser) adds benefit to ranibizumab injections in patients with macular edema from retinal vein occlusion (RVO) and to compare 0.5-mg with 2.0-mg ranibizumab. Design Randomized, double-masked, controlled clinical trial. Participants Thirty-nine patients with central RVO (CRVO) and 42 with branch RVO (BRVO). Methods Subjects were randomized to 0.5 mg or 2.0 mg ranibizumab every 4 weeks for 24 weeks and re-randomized to pro re nata ranibizumab plus laser or ranibizumab alone. Main Outcome Measures Mean change from baseline best-corrected visual acuity (BCVA) at week 24 for BCVA at weeks 48, 96, and 144 for second randomization. Results Mean improvement from baseline BCVA at week 24 was 15.5 and 15.8 letters in the 0.5-mg and 2.0-mg CRVO groups, and 12.1 and 14.6 letters in the 0.5-mg and 2.0-mg BRVO groups. For CRVO, but not BRVO, there was significantly greater reduction from baseline mean central subfield thickness (CST) in the 2.0-mg versus 0.5-mg group (396.1 vs. 253.5 μm; P = 0.03). For the second randomization in CRVO patients, there was no significant difference from week 24 BCVA in the ranibizumab plus laser versus the ranibizumab only groups at week 48 (-3.3 vs. 0.0 letters), week 96 (+0.69 vs. -1.6 letters), or week 144 (+0.4 vs. -6.7 letters), and a significant increase from week 24 mean CST at week 48 (+94.7 vs. +15.2 μm; P = 0.05) but not weeks 96 or 144. For BRVO, there was a significant reduction from week 24 mean BCVA in ranibizumab plus laser versus ranibizumab at week 48 (-7.5 vs. +2.8; P <0.01) and week 96 (-2.0 vs. +4.8; P <0.03), but not week 144, and there were no differences in mean CST change from week 24 at weeks 48, 96, or 144. Laser failed to increase edema resolution or to reduce the ranibizumab injections between weeks 24 and 144. Conclusions In patients with macular edema resulting from RVO, there was no short-term clinically significant benefit from monthly injections of 2.0-mg versus 0.5-mg ranibizumab injections and no long-term benefit in BCVA, resolution of edema, or number of ranibizumab injections obtained by addition of laser treatment to ranibizumab.

AB - Purpose To determine whether scatter and grid laser photocoagulation (laser) adds benefit to ranibizumab injections in patients with macular edema from retinal vein occlusion (RVO) and to compare 0.5-mg with 2.0-mg ranibizumab. Design Randomized, double-masked, controlled clinical trial. Participants Thirty-nine patients with central RVO (CRVO) and 42 with branch RVO (BRVO). Methods Subjects were randomized to 0.5 mg or 2.0 mg ranibizumab every 4 weeks for 24 weeks and re-randomized to pro re nata ranibizumab plus laser or ranibizumab alone. Main Outcome Measures Mean change from baseline best-corrected visual acuity (BCVA) at week 24 for BCVA at weeks 48, 96, and 144 for second randomization. Results Mean improvement from baseline BCVA at week 24 was 15.5 and 15.8 letters in the 0.5-mg and 2.0-mg CRVO groups, and 12.1 and 14.6 letters in the 0.5-mg and 2.0-mg BRVO groups. For CRVO, but not BRVO, there was significantly greater reduction from baseline mean central subfield thickness (CST) in the 2.0-mg versus 0.5-mg group (396.1 vs. 253.5 μm; P = 0.03). For the second randomization in CRVO patients, there was no significant difference from week 24 BCVA in the ranibizumab plus laser versus the ranibizumab only groups at week 48 (-3.3 vs. 0.0 letters), week 96 (+0.69 vs. -1.6 letters), or week 144 (+0.4 vs. -6.7 letters), and a significant increase from week 24 mean CST at week 48 (+94.7 vs. +15.2 μm; P = 0.05) but not weeks 96 or 144. For BRVO, there was a significant reduction from week 24 mean BCVA in ranibizumab plus laser versus ranibizumab at week 48 (-7.5 vs. +2.8; P <0.01) and week 96 (-2.0 vs. +4.8; P <0.03), but not week 144, and there were no differences in mean CST change from week 24 at weeks 48, 96, or 144. Laser failed to increase edema resolution or to reduce the ranibizumab injections between weeks 24 and 144. Conclusions In patients with macular edema resulting from RVO, there was no short-term clinically significant benefit from monthly injections of 2.0-mg versus 0.5-mg ranibizumab injections and no long-term benefit in BCVA, resolution of edema, or number of ranibizumab injections obtained by addition of laser treatment to ranibizumab.

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