Elsevier

Ophthalmology

Volume 116, Issue 6, June 2009, Pages 1142-1150
Ophthalmology

Original article
Randomized Trial of Intravitreal Bevacizumab Alone or Combined with Triamcinolone versus Macular Photocoagulation in Diabetic Macular Edema

Presented at: American Academy of Ophthalmology Annual Meeting, November 2008, Atlanta, Georgia.
https://doi.org/10.1016/j.ophtha.2009.01.011Get rights and content

Purpose

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

Design

Randomized 3-arm clinical trial.

Participants

A total of 150 eyes of 129 patients with clinically significant DME and no previous treatment.

Methods

The eyes were randomly assigned to 1 of the 3 study arms: the IVB group, patients who received 1.25 mg IVB (50 eyes); the IVB/IVT group, patients who received 1.25 mg of IVB and 2 mg of IVT (50 eyes); and the MPC group, patients who underwent focal or modified grid laser (50 eyes). Retreatment was performed at 12-week intervals whenever indicated.

Main Outcome Measures

Change in best-corrected visual acuity (VA) at week 24.

Results

VA changes among the groups were statistically significant at 6 (P<0.001) and 24 (P = 0.012) weeks. The significant treatment effect was demonstrated in the IVB group at all follow-up visits and in the IVB/IVT group at 6 and 12 weeks. VA changes ± standard deviation at 36 weeks were −0.28±0.25, −0.04±0.33, and +0.01±0.27 logarithm of minimum angle of resolution in the IVB, IVB/IVT, and MPC groups, respectively (P = 0.053). Significant central macular thickness (CMT) reduction was observed in all groups only up to 6 weeks; however, CMT changes were not significant among the groups in all visits. Overall, retreatment was required for 27 eyes up to 36 weeks (14 in the IVB group, 10 in the IVB/IVT group, and 3 in the MPC group). In the IVB group, in which a greater VA improvement was observed, only 1 injection was required in 72% of the cases. VA improvement >2 Snellen lines at 36 weeks was detected in 37%, 25%, and 14.8% of patients in the IVB, IVB/IVT, and MPC groups, respectively.

Conclusions

Intravitreal bevacizumab injection in patients with DME yielded a better visual outcome at 24 weeks compared with macular photocoagulation. A change in CMT beyond the 6-week time point that corresponded to the vision change was not detected. No adjunctive effect of IVT was demonstrated.

Financial Disclosure(s)

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Section snippets

Patients and Methods

This clinical trial was approved by institutional review board of ophthalmic research center of Labbafinejad Medical Center (Tehran, Iran). The study protocol and its probable safety and efficacy of the interventions were explained to all participants before enrollment. Informed consent was obtained from all patients.

Results

In this trial, 150 eyes of 129 patients were enrolled and followed from September 2005 to May 2007. The mean age of patients ± standard deviation was 61.2±6.1 years. Seventy-nine eyes (52.7%) were from male patients. A total of 141 (94%) eyes had nonproliferative diabetic retinopathy, and 9 eyes (6%) had early proliferative diabetic retinopathy. The general characteristics of each treatment group are summarized in Table 1.

The eyes were randomly assigned to one of the treatment groups: (1) 50

Discussion

This 3-arm randomized clinical trial demonstrated the superiority of IVB injection either alone or in combination with triamcinolone acetonide over MPC in VA improvement up to 24 weeks in primary treatment of DME. This improving effect persisted longer in the IVB group (up to 36 weeks) than in the IVB/IVT group (up to 12 weeks). In the MPC group, no improvement in VA was observed at all follow-up visits. In regard to CMT reduction, there was no meaningful superiority of the IVB and IVB/IVT

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    Trial registration: clinical trials.gov identifier: NCT00370669.

    Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

    Supported by the Ophthalmic Research Center of Shahid Beheshti University (MC) Tehran, Iran.

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