Original articleRandomized Trial of Intravitreal Bevacizumab Alone or Combined with Triamcinolone versus Macular Photocoagulation in Diabetic Macular Edema
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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2021, Ophthalmology RetinaCitation Excerpt :However, the data obtained are consistent with previous publications of anti-VEGF agents used in conjunction with ocular corticosteroids in the treatment of DME. Specifically, prior studies generally showed similar outcomes with modest anatomic benefit and potential to address treatment burden, but little visual benefit.20,24–27 As noted previously, DRCR.net protocol U was a phase 2 multicenter randomized clinical trial in eyes with persistent DME that compared continued anti-VEGF monotherapy (ranibizumab) with ranibizumab plus intravitreal dexamethasone implant.20
Manuscript no. 2008-978.
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.