Intravitreal bevacizumab (avastin) injection alone or combined with triamcinolone versus macular photocoagulation as primary treatment of diabetic macular edema.

Abstract

PURPOSE:

To report the efficacy of a single intravitreal bevacizumab injection alone or in combination with intravitreal triamcinolone acetonide versus macular laser photocoagulation (MPC) as primary treatment of diabetic macular edema (DME).

METHODS:

In this randomized, three-arm clinical trial, 103 eyes of 97 patients with clinically significant DME and no previous treatment were enrolled. The eyes were randomly assigned to one of three study arms: the intravitreal bevacizumab (IVB) group, patients who received 1.25 mg of intravitreal bevacizumab (37 eyes); the IVB/IVT group, patients who received 1.25 mg of intravitreal bevacizumab and 2 mg of intravitreal triamcinolone (33 eyes); and the MPC group, patients who underwent focal or modified grid laser (33 eyes). Primary outcome measure was change in visual acuity.

RESULTS:

Visual acuity changes +/- SD at 12 weeks were -0.22 +/- 0.23, -0.13 +/- 0.31, and + 0.08 +/- 0.31 logarithm of the minimal angle of resolution in the IVB, IVB/IVT, and MPC groups, respectively. The marginal regression model based on generalized estimating equation analysis demonstrated that the visual acuity changes in the groups were statistically significant at both 6 weeks (P < 0.0001) and 12 weeks (P = 0.024). The significant treatment effect was demonstrated at both 6 weeks and 12 weeks in the IVB group and only at 6 weeks in the IVB/IVT group. Significant central macular thickness (CMT) reduction was observed in eyes in the IVB and IVB/IVT groups only up to 6 weeks; however, CMT changes were not significant in the groups.

CONCLUSION:

Up to 12 weeks, intravitreal bevacizumab treatment of patients with DME yielded better visual outcome than laser photocoagulation, although it was not associated with a significant decrease in CMT. No further beneficial effect of intravitreal triamcinolone could be demonstrated. Further clinical trials with longer follow-up are required to evaluate the long-term visual outcomes and complication profiles after primary treatment with such medications.

• Authors: Masoud Soheilian, Alireza Ramezani, Bijan Bijanzadeh, Mehdi Yaseri, Hamid Ahmadieh, Mohammad H Dehghan, Mohsen Azarmina, Siamak Moradian, Homa Tabatabaei, Gholam A Peyman
• Journal: Retina (Philadelphia, Pa.) (Retina) 2007 Nov-Dec Vol. 27 Issue 9 Pg. 1187-95 ISSN: 0275-004X [Print] United States
• PMID: 18046223 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Angiogenesis Inhibitors
• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Glucocorticoids
• Vascular Endothelial Growth Factor A
• Bevacizumab
• Triamcinolone Acetonide

Topics

• Angiogenesis Inhibitors (administration & dosage)
• Antibodies, Monoclonal (administration & dosage)
• Antibodies, Monoclonal, Humanized
• Bevacizumab
• Diabetic Retinopathy (drug therapy, surgery, therapy)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Glucocorticoids (administration & dosage)
• Humans
• Injections
• Laser Coagulation (methods)
• Macular Edema (drug therapy, surgery, therapy)
• Male
• Middle Aged
• Prospective Studies
• Tomography, Optical Coherence
• Treatment Outcome
• Triamcinolone Acetonide (administration & dosage)
• Vascular Endothelial Growth Factor A (antagonists & inhibitors)
• Visual Acuity
• Vitreous Body