Combined Laser Photocoagulation With Intravitreal Triamcinolone for the Treatment of Proliferative Diabetic Retinopathy and Macular Edema: One-Year Results of a Randomized Clinical Trial

Abstract

Purpose: : To evaluate the morphofunctional effects of intravitreal triamcinolone acetonide (IVTA) combined with laser photocoagulation for the management of patients with proliferative diabetic retinopathy (PDR) complicated with macular edema.

Methods: : Single-center, active-controlled, randomized clinical trial including 22 patients with "early" PDR and clinically significant macular edema in both eyes. Standard laser (panretinal and macular) photocoagulation was performed in each eye according to Early Treatment Diabetic Retinopathy Study guidelines, followed by one IVTA of 4mg in one randomly assigned eye after completion of the laser treatment at week 3. Standardized ophthalmic evaluation including LogMAR best-corrected visual acuity (BCVA), fundus photography and optical coherence tomography was performed at baseline and at months 1, 3, 6, 9, and 12 after treatment. Main outcome measures included changes in BCVA as well as in central macular thickness (CMT) and macular volume.

Results: : The mean LogMAR BCVA (Snellen equivalent) at baseline was 0.44 (20/50^-2) for IVTA group and 0.38 (20/50⁺¹) for the controls (p=0.019). Mean BVCA was significantly improved in IVTA group when compared with controls at all follow-up periods of the study (p<0.001). The mean CMT and macular volume at baseline was, respectively, 360µm and 8.6mm³ for IVTA group, and 331µm and 8.4mm³ for the controls (p=0.148, p=0.483). Mean CMT and macular volume were significantly reduced in IVTA group when compared with controls at all follow-up periods of the study (p<0.001). Throughout the study, complimentary macular photocoagulation was required in 59.1% of the controls, and in 9.1% in the IVTA group. Transitory increase in intraocular pressure was found in the IVTA group at month 1.

Conclusions: : The combination of IVTA with laser photocoagulation was associated with favorable results on BCVA and macular remodeling when compared with laser photocoagulation alone for the treatment of early PDR with DME. Larger studies are required to confirm our preliminary findings.

Clinical Trial: : www.clinicaltrials.gov NCT00443521

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • diabetic retinopathy • edema