Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment

5-year randomized trial results

Michael J. Elman, Allison Ayala, Neil M Bressler, David Browning, Christina J. Flaxel, Adam R. Glassman, Lee M. Jampol, Thomas W. Stone

Research output: Contribution to journalArticle

Abstract

Objective To report 5-year results from a previously reported trial evaluating intravitreal 0.5 mg ranibizumab with prompt versus deferred (for ≥24 weeks) focal/grid laser treatment for diabetic macular edema (DME). Design Multicenter, randomized clinical trial. Participants Among participants from the trial with 3 years of follow-up who subsequently consented to a 2-year extension and survived through 5 years, 124 (97%) and 111 (92%) completed the 5-year visit in the prompt and deferred groups, respectively. Methods Random assignment to ranibizumab every 4 weeks until no longer improving (with resumption if worsening) and prompt or deferred (≥24 weeks) focal/grid laser treatment. Main Outcome Measures Best-corrected visual acuity at the 5-year visit. Results The mean change in visual acuity letter score from baseline to the 5-year visit was +7.2 letters in the prompt laser group compared with +9.8 letters in the deferred laser group (mean difference, -2.6 letters; 95% confidence interval, -5.5 to +0.4 letters; P = 0.09). At the 5-year visit in the prompt versus deferred laser groups, there was vision loss of ≥10 letters in 9% versus 8%, an improvement of ≥10 letters in 46% versus 58%, and an improvement of ≥15 letters in 27% versus 38% of participants, respectively. From baseline to 5 years, 56% of participants in the deferred group did not receive laser. The median number of injections was 13 versus 17 in the prompt and deferral groups, including 54% and 45% receiving no injections during year 4 and 62% and 52% receiving no injections during year 5, respectively. Conclusions Five-year results suggest focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better than deferring laser treatment for ≥24 weeks in eyes with DME involving the central macula with vision impairment. Although more than half of eyes in which laser treatment is deferred may avoid laser for at least 5 years, such eyes may require more injections to achieve these results when following this protocol. Most eyes treated with ranibizumab and either prompt or deferred laser maintain vision gains obtained by the first year through 5 years with little additional treatment after 3 years.

Original languageEnglish (US)
Pages (from-to)375-381
Number of pages7
JournalOphthalmology
Volume122
Issue number2
DOIs
StatePublished - Feb 1 2015

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Macular Edema
Lasers
Therapeutics
Injections
Visual Acuity
Ranibizumab
Randomized Controlled Trials
Outcome Assessment (Health Care)
Confidence Intervals

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment : 5-year randomized trial results. / Elman, Michael J.; Ayala, Allison; Bressler, Neil M; Browning, David; Flaxel, Christina J.; Glassman, Adam R.; Jampol, Lee M.; Stone, Thomas W.

In: Ophthalmology, Vol. 122, No. 2, 01.02.2015, p. 375-381.

Research output: Contribution to journalArticle

Elman, Michael J. ; Ayala, Allison ; Bressler, Neil M ; Browning, David ; Flaxel, Christina J. ; Glassman, Adam R. ; Jampol, Lee M. ; Stone, Thomas W. / Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment : 5-year randomized trial results. In: Ophthalmology. 2015 ; Vol. 122, No. 2. pp. 375-381.
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abstract = "Objective To report 5-year results from a previously reported trial evaluating intravitreal 0.5 mg ranibizumab with prompt versus deferred (for ≥24 weeks) focal/grid laser treatment for diabetic macular edema (DME). Design Multicenter, randomized clinical trial. Participants Among participants from the trial with 3 years of follow-up who subsequently consented to a 2-year extension and survived through 5 years, 124 (97{\%}) and 111 (92{\%}) completed the 5-year visit in the prompt and deferred groups, respectively. Methods Random assignment to ranibizumab every 4 weeks until no longer improving (with resumption if worsening) and prompt or deferred (≥24 weeks) focal/grid laser treatment. Main Outcome Measures Best-corrected visual acuity at the 5-year visit. Results The mean change in visual acuity letter score from baseline to the 5-year visit was +7.2 letters in the prompt laser group compared with +9.8 letters in the deferred laser group (mean difference, -2.6 letters; 95{\%} confidence interval, -5.5 to +0.4 letters; P = 0.09). At the 5-year visit in the prompt versus deferred laser groups, there was vision loss of ≥10 letters in 9{\%} versus 8{\%}, an improvement of ≥10 letters in 46{\%} versus 58{\%}, and an improvement of ≥15 letters in 27{\%} versus 38{\%} of participants, respectively. From baseline to 5 years, 56{\%} of participants in the deferred group did not receive laser. The median number of injections was 13 versus 17 in the prompt and deferral groups, including 54{\%} and 45{\%} receiving no injections during year 4 and 62{\%} and 52{\%} receiving no injections during year 5, respectively. Conclusions Five-year results suggest focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better than deferring laser treatment for ≥24 weeks in eyes with DME involving the central macula with vision impairment. Although more than half of eyes in which laser treatment is deferred may avoid laser for at least 5 years, such eyes may require more injections to achieve these results when following this protocol. Most eyes treated with ranibizumab and either prompt or deferred laser maintain vision gains obtained by the first year through 5 years with little additional treatment after 3 years.",
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AU - Browning, David

AU - Flaxel, Christina J.

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N2 - Objective To report 5-year results from a previously reported trial evaluating intravitreal 0.5 mg ranibizumab with prompt versus deferred (for ≥24 weeks) focal/grid laser treatment for diabetic macular edema (DME). Design Multicenter, randomized clinical trial. Participants Among participants from the trial with 3 years of follow-up who subsequently consented to a 2-year extension and survived through 5 years, 124 (97%) and 111 (92%) completed the 5-year visit in the prompt and deferred groups, respectively. Methods Random assignment to ranibizumab every 4 weeks until no longer improving (with resumption if worsening) and prompt or deferred (≥24 weeks) focal/grid laser treatment. Main Outcome Measures Best-corrected visual acuity at the 5-year visit. Results The mean change in visual acuity letter score from baseline to the 5-year visit was +7.2 letters in the prompt laser group compared with +9.8 letters in the deferred laser group (mean difference, -2.6 letters; 95% confidence interval, -5.5 to +0.4 letters; P = 0.09). At the 5-year visit in the prompt versus deferred laser groups, there was vision loss of ≥10 letters in 9% versus 8%, an improvement of ≥10 letters in 46% versus 58%, and an improvement of ≥15 letters in 27% versus 38% of participants, respectively. From baseline to 5 years, 56% of participants in the deferred group did not receive laser. The median number of injections was 13 versus 17 in the prompt and deferral groups, including 54% and 45% receiving no injections during year 4 and 62% and 52% receiving no injections during year 5, respectively. Conclusions Five-year results suggest focal/grid laser treatment at the initiation of intravitreal ranibizumab is no better than deferring laser treatment for ≥24 weeks in eyes with DME involving the central macula with vision impairment. Although more than half of eyes in which laser treatment is deferred may avoid laser for at least 5 years, such eyes may require more injections to achieve these results when following this protocol. Most eyes treated with ranibizumab and either prompt or deferred laser maintain vision gains obtained by the first year through 5 years with little additional treatment after 3 years.

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