Effect of Crocin monotherapy on the non-center involved diabetic macular edema: A randomized clinical trial
Dr. Seyedeh Maryam Hosseini1 *, Dr. Ali Eslami1 , Dr. Seyed ahmad mohajeri2 , Dr. Mina mohajeri2 , Dr. Samaneh Sepahi3
- Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
- Pharmaceutical Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran
- Targeted Drug Delivery Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran
Abstract: Diabetic macular edema (DME) is one of the most important complications of diabetic retinopathy and the main cause of visual loss in diabetes mellitus. One-third of diabetic patients have maculopathy, and one-third have vision-threatening maculopathy. Without prompt and appropriate treatment, DME can lead to severe and irreversible vision loss in diabetic patients. Center-involved DME needs standard treatment with anti-VEGF , however there is controversy regarding the treatment of mild to moderate or non-center involved (non-CI-DME) with good visual acuity. We aimed to evaluate the efficacy of crocin in the treatment of non CI-DME with good visual acuity.
Methods: In this placebo-controlled double-masked randomized clinical trial, patients with good controlled diabetes mellitus (HbA1c between 7 to 8.5) who have treatment -naïve non CI-DME and non-proliferative diabetic retinopathy of stage less than very severe were recruited. The patients were randomized into two groups of crocin 15 mg/day and placebo for 3 months. Complete eye examinations including best corrected visual acuity (BCVA), anterior segment and fundus exam and macular optical coherence tomography for measurement of central, parafoveal and perifoveal were performed
Results: 25 Eyes in crocin group and 28 Eyes in placebo group were ended the study. Mean age was 59 years old .There is no significant difference between two groups in terms of age ,sex , stage of retinopathy, HbA1C at the beginning of the study (P-value>0.05).
Following 3 months treatment, the average and maximum thickness values in the parafovea region were significantly reduced (P-value= 0.002 and 0.003, respectively) in crocin group compared to placebo. Also, the average and maximum thickness values in the perifovea region were significantly decreased (P-value = 0.003 and 0.01, respectively) in crocin group in comparison with placebo. No significant change was observed in FBS values and BCVA values between two groups and within groups (before and after treatment). HbA1C was significantly reduced in crocin group (P-value = 0.004) compared to placebo. No serious side effect was observed in crocin and placebo groups.
Conclusion: In this study, the effect of crocin as monotherapy in reducing the thickness of the areas around the center of macula in non CI-DME was demonstrated. More study with larger sample size is suggested.
