Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: 5-year randomized trial results
Open accessAbstract
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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For diabetic macular edema managed with anti-VEGF therapy, most patients need no treatment after 3 years.
“where the majority of patients do not require treatment beyond 3 years.”
From Five-Year Outcomes with Anti–Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration (2016) · cites this paper as [35]
In the Diabetic Retinopathy Clinical Research Network Protocol I trial, mean injections were 8 or 9 in Year 1, 2 or 3 in Year 2, 1 or 2 in Year 3, and 0 or 1 in Year 4, depending on treatment assignment.
“In Diabetic Retinopathy Clinical Research Network Protocol I clinical trial, a mean of 8 or 9 injections were given in Year 1, decreasing to 2 or 3 in Year 2, to 1 or 2 in Year 3, and to 0 or 1 in Year 4, depending on treatment assignment.35”
From Five-Year Outcomes with Anti–Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration (2016) · cites this paper as [35]
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- Authors
- Elman, M. J., Ayala, A., Bressler, N. M., Browning, D., Flaxel, C. J., Glassman, A. R., Jampol, L. M., & Stone, T. W.
- Affiliations
- Elman Retina Group (US)
- Jaeb Center for Health Research (US)
- Johns Hopkins University (US)
- Charlotte Eye Ear Nose & Throat Associates (US)
- Northwestern University (US)
- Retina Associates of Kentucky (US)
- Corresponding author
- Ayala, Allison
- ORCID
- Venue
- Ophthalmology
- Publisher
- Elsevier BV
- Published
- 2015-02
- Volume
- 122
- Issue
- 2
- Pages
- 375-381
- ISSN
- 0161-6420 (ISSN-L)
- PMC
- PMC4520307
- OpenAlex
- W1980342089
- Cited by
- 562
- References
- 10
- Citations by year
- 2026: 8 · 2025: 18 · 2024: 22 · 2023: 20 · 2022: 35 · 2021: 39 · 2020: 55 · 2019: 41 · 2018: 45 · 2017: 79 · 2016: 72 · 2015: 73 · 2014: 29 · 2013: 25 · 2012: 1
- FWCI
- 79.09
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Ophthalmology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Eye Institute (EY14231, EY-14229, EY18817, EY023207, U10EY018817, U10EY014229, U10EY023207, U10EY014231, UG1EY014231)
- Topics
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Retinal and Macular Surgery
- Health Sciences › Medicine › Ophthalmology › Ocular Diseases and Behçet’s Syndrome
- Keywords
- diabetic macular edema, ranibizumab, intravitreal injection, best-corrected visual acuity, long-term visual outcomes, anti-VEGF therapy, vision loss, treatment duration extension, retinal laser treatment, anti-angiogenic therapy, treatment burden reduction
- MeSH terms
- Ranibizumab, Aged, Combined Modality Therapy, Diabetic Retinopathy, Female, Humans, Macular Edema, Male, Middle Aged, Visual Acuity, Treatment Outcome, Laser Coagulation, Angiogenesis Inhibitors, Vascular Endothelial Growth Factor A, Intravitreal Injections, Antibodies, Monoclonal, Humanized
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