Five-Year Outcomes of Ranibizumab With Prompt or Deferred Laser Versus Laser or Triamcinolone Plus Deferred Ranibizumab for Diabetic Macular Edema.

Abstract

PURPOSE:

To compare long-term vision and anatomic effects of ranibizumab with prompt or deferred laser vs laser or triamcinolone + laser with very deferred ranibizumab in diabetic macular edema (DME).

DESIGN:

Randomized clinical trial.

METHODS:

Eight hundred and twenty-eight study eyes (558 [67%] completed the 5-year visit), at 52 sites, with visual acuity 20/32 to 20/320 and DME involving the central macula were randomly assigned to intravitreous ranibizumab (0.5 mg) with either (1) prompt or (2) deferred laser; (3) sham injection + prompt laser; or (4) intravitreous triamcinolone (4 mg) + prompt laser. The latter 2 groups could initiate ranibizumab as early as 74 weeks from baseline, for persistent DME with vision impairment. The main outcome measures were visual acuity, optical coherence central subfield thickness, and number of injections through 5 years.

RESULTS:

At 5 years mean (± standard deviation) change in Early Treatment Diabetic Retinopathy Study visual acuity letter scores from baseline in the ranibizumab + deferred laser (N = 111), ranibizumab + prompt laser (N = 124), laser/very deferred ranibizumab (N = 198), and triamcinolone + laser/very deferred ranibizumab (N = 125) groups were 10 ± 13, 8 ± 13, 5 ± 14, and 7 ± 14, respectively. The difference (95% confidence interval) in mean change between ranibizumab + deferred laser and laser/very deferred ranibizumab and triamcinolone + laser/very deferred ranibizumab was 4.4 (1.2-7.6, P = .001) and 2.8 (-0.9 to 6.5, P = .067), respectively, at 5 years.

CONCLUSIONS:

Recognizing limitations of follow-up available at 5 years, eyes receiving initial ranibizumab therapy for center-involving DME likely have better long-term vision improvements than eyes managed with laser or triamcinolone + laser followed by very deferred ranibizumab for persistent thickening and vision impairment.

• Authors: Susan B Bressler, Adam R Glassman, Talat Almukhtar, Neil M Bressler, Frederick L Ferris, Joseph M Googe Jr, Shailesh K Gupta, Lee M Jampol, Michele Melia, John A Wells 3rd, Diabetic Retinopathy Clinical Research Network
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 164 Pg. 57-68 (Apr 2016) ISSN: 1879-1891 [Electronic] United States
• PMID: 26802783 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2016 Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Glucocorticoids
• VEGFA protein, human
• Vascular Endothelial Growth Factor A
• Triamcinolone Acetonide
• Ranibizumab

Topics

• Aged
• Angiogenesis Inhibitors (therapeutic use)
• Combined Modality Therapy
• Diabetic Retinopathy (diagnosis, drug therapy, physiopathology)
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Glucocorticoids (therapeutic use)
• Humans
• Intravitreal Injections
• Laser Coagulation
• Macular Edema (diagnosis, drug therapy, physiopathology)
• Male
• Middle Aged
• Ranibizumab (therapeutic use)
• Tomography, Optical Coherence
• Treatment Outcome
• Triamcinolone Acetonide (therapeutic use)
• Vascular Endothelial Growth Factor A (antagonists & inhibitors)
• Visual Acuity (drug effects, physiology)