Randomized trial evaluating short-term effects of intravitreal ranibizumab or triamcinolone acetonide on macular edema after focal/grid laser for diabetic macular edema in eyes also receiving panretinal photocoagulation.

Abstract

PURPOSE:

To evaluate 14-week effects of intravitreal ranibizumab or triamcinolone in eyes receiving focal/grid laser for diabetic macular edema and panretinal photocoagulation.

METHODS:

Three hundred and forty-five eyes with a visual acuity of 20/320 or better, center-involved diabetic macular edema receiving focal/grid laser, and diabetic retinopathy receiving prompt panretinal photocoagulation were randomly assigned to sham (n = 123), 0.5-mg ranibizumab (n = 113) at baseline and 4 weeks, and 4-mg triamcinolone at baseline and sham at 4 weeks (n = 109). Treatment was at investigator discretion from 14 weeks to 56 weeks.

RESULTS:

Mean changes (±SD) in visual acuity letter score from baseline were significantly better in the ranibizumab (+1 ± 11; P < 0.001) and triamcinolone (+2 ± 11; P < 0.001) groups compared with those in the sham group (-4 ± 14) at the 14-week visit, mirroring retinal thickening results. These differences were not maintained when study participants were followed for 56 weeks for safety outcomes. One eye (0.9%; 95% confidence interval, 0.02%-4.7%) developed endophthalmitis after receiving ranibizumab. Cerebrovascular/cardiovascular events occurred in 4%, 7%, and 3% of the sham, ranibizumab, and triamcinolone groups, respectively.

CONCLUSION:

The addition of 1 intravitreal triamcinolone injection or 2 intravitreal ranibizumab injections in eyes receiving focal/grid laser for diabetic macular edema and panretinal photocoagulation is associated with better visual acuity and decreased macular edema by 14 weeks. Whether continued long-term intravitreal treatment is beneficial cannot be determined from this study.

• Authors: Diabetic Retinopathy Clinical Research Network, Joseph Googe, Alexander J Brucker, Neil M Bressler, Haijing Qin, Lloyd P Aiello, Andrew Antoszyk, Roy W Beck, Susan B Bressler, Frederick L Ferris 3rd, Adam R Glassman, Dennis Marcus, Cynthia R Stockdale
• Journal: Retina (Philadelphia, Pa.) (Retina) Vol. 31 Issue 6 Pg. 1009-27 (Jun 2011) ISSN: 1539-2864 [Electronic] United States
• PMID: 21394052 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

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

Topics

• Angiogenesis Inhibitors (administration & dosage)
• Antibodies, Monoclonal (administration & dosage)
• Antibodies, Monoclonal, Humanized
• Diabetic Retinopathy (drug therapy, surgery)
• Female
• Glucocorticoids (administration & dosage)
• Humans
• Intravitreal Injections
• Laser Coagulation
• Macular Edema (drug therapy, surgery)
• Male
• Middle Aged
• Postoperative Care
• Ranibizumab
• Triamcinolone Acetonide (administration & dosage)
• Vascular Endothelial Growth Factor A (antagonists & inhibitors)
• Visual Acuity (physiology)