Intravitreal Diclofenac plus Bevacizumab versus Bevacizumab alone in treatment-naive diabetic macular edema: a randomized double-blind clinical trial.
The aim of this study is to evaluate the short-term effects of a single intravitreal injection of 1.25 mg Bevacizumab combined with 300 lg/0.1 mL Diclofenac (IVB/D) versus 1.25 mg intravitreal Bevacizumab (IVB) alone in the treatment of naive diabetic macular edema (DME). In this prospective, randomized clinical trial, 80 eyes were included in the final analysis; 42 and 38 of which in the IVB and IVB/D groups, respectively. The primary outcome measure was a change in best-corrected visual acuity (BCVA) in logMAR at week 4. The secondary outcomes included changes in central macular thickness (CMT), macular volume, and potential injection-related complications. Significant improvement of BCVA was demonstrated in both study arms (mean reductions in LogMAR: -0.088 ± 0.278, -0.228 ± 0.330 for IVB and IVB/D, respectively). The difference in BCVA changes was in favor of IVB/D; however, not to a statistically significant level (P = 0.160). Significant reduction of CMT was documented in both study arms (mean reductions: 82.43 ± 160.09 and 153.26 ± 163.85 for IVB and IVB + IVD, respectively). Comparison of CMT changes between groups showed that IVB/D reduced CMT more than that of IVB (P = 0.04). Effects on macular volume corresponded to those of CMT. No injection-related complications or significant alterations in intraocular pressure were observed in any of the study arms. In treatment-naive DME, superiority of IVB/D combination therapy over IVB monotherapy may exist; especially as regards anatomical features. In our therapeutic arsenal for DME, IVD can be added as an adjunct to Bevacizumab.
Isfahan Eye Research Center (IERC), Feiz Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.|Department of Ophthalmology, Feiz Hospital, Isfahan University of Medical Sciences, Qods Sq, Isfahan, Iran.
Heshmatollah
H
Ghanbari
Isfahan Eye Research Center (IERC), Feiz Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.|Department of Ophthalmology, Feiz Hospital, Isfahan University of Medical Sciences, Qods Sq, Isfahan, Iran.
Farzan
F
Kianersi
Isfahan Eye Research Center (IERC), Feiz Hospital, Isfahan University of Medical Sciences, Isfahan, Iran. sonbolestan_ali@yahoo.com.|Department of Ophthalmology, Feiz Hospital, Isfahan University of Medical Sciences, Qods Sq, Isfahan, Iran. sonbolestan_ali@yahoo.com.
Seyed Ali
SA
Sonbolestan
Isfahan Eye Research Center (IERC), Feiz Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.|Department of Ophthalmology, Feiz Hospital, Isfahan University of Medical Sciences, Qods Sq, Isfahan, Iran.
Mohammad-Ali
MA
Abtahi
Department of Epidemiology, School of Health and Nutrition, Shiraz University of Medical Sciences, Shiraz, Iran.
Mojataba
M
Akbari
Isfahan Eye Research Center (IERC), Feiz Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.|Department of Ophthalmology, Feiz Hospital, Isfahan University of Medical Sciences, Qods Sq, Isfahan, Iran.
Zahra-Alsadat
ZA
Abtahi
Isfahan Eye Research Center (IERC), Feiz Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.|Department of Ophthalmology, Feiz Hospital, Isfahan University of Medical Sciences, Qods Sq, Isfahan, Iran.
Seyed-Hossein
SH
Abtahi
D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D000068258:Bevacizumab / Q000008:administration & dosage*; D003930:Diabetic Retinopathy / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D004008:Diclofenac / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008266:Macula Lutea / Q000473:pathology; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity
D020533:Angiogenesis Inhibitors; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; D000068258:Bevacizumab
Bevacizumab; Diabetic Retinopathy; Diabetic macular edema; Diclofenac; Intravitreal injection; NSAIDs