Crocin Monotherapy in Non-Central Diabetic Macular Edema

Mojtaba Mojtahedzadeh; Masoud Reza Manaviat; Seyed Reza Mirjalili; Adeleh Sahebnasagh; Mohammad Khan Ardani; Farahnaz Hoseinzadeh; Fatemeh  Saghafi

doi:10.18502/jpc.v12i4.17451

Mojtaba Mojtahedzadeh Department of Clinical Pharmacy, The Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Tehran, Iran
Masoud Reza Manaviat Geriatric ophthalmology research center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Seyed Reza Mirjalili Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Adeleh Sahebnasagh Department of Internal Medicine, Clinical Research Center, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran.
Mohammad Khan Ardani Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Farahnaz Hoseinzadeh Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Fatemeh Saghafi Department of Clinical Pharmacy, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.

DOI: https://doi.org/10.18502/jpc.v12i4.17451

Keywords: Diabetic retinopathy; Macular edema; Crocin; Visual acuity.

Abstract

Background: Crocin can be utilized as an anti-inflammatory component of Saffron in diabetic macular edema (DME), which is known as the most common cause of vision loss in patients with diabetes mellitus (DM). Although anti-vascular endothelial growth factor (VEGF) agents are common in non-center involving DME (NCI-DME), there is no consensus on NCI-DME treatment.

Methods: This before-after study was performed from October 2019 to August 2021. Twenty-six eyes of 16 patients with type 2 DM in Baghayipoor Clinic in Yazd, were treated with 15 mg crocin per day for 90 days. Patients had at least one eye with non-proliferative DR (NPDR) and NCI-DME along with no adherence to intravitreal injection or a contraindication of intravitreal injection. Central subfield thickness (CST), visual acuity, fasting blood sugar (FBS), and HbA1c were assessed once before and once after the study (day 90).

Results: After 90 days of therapy, the mean CST significantly decreased to 2.8 μm (P-value=0.030), four patients had increased CST and 1 patient had a significantly decreased CST (≥25μm). The mean Logarithmic Minimum angle of resolution increased during the study. The Mean (±SD) FBS showed a significant improvement during the study from 174.7 (±60.41) at baseline up to 161.8 (±47.7) at day 90 (P-value = 0.012). HbA1c had no significant reduction. Nausea/vomiting and insomnia were among the reported adverse effects. Nevertheless, no one withdrew from the study because of the adverse effects.

Conclusion: This study suggests Crocin's positive impact on NCI-DME. It may also improve the glycemic profile of diabetic patients; however, more high-quality randomized clinical trials with larger sample sizes and longer durations are needed for validation.