Crocin Supplementation in CSCR

Efficacy and Safety of Crocin Supplementation in Patients With Central Serous Chorioretinopathy (CSCR)

Preclinical and clinical evidence support the protective effect of crocin on different pathologic pathways involved in central serous chorioretinopathy (CSCR). They involve inflammation, oxidative stress, mineralocorticoid pathway, and also stress-related injuries. It also showed that crocin has a protective effect on the retinal pigmented epithelium (RPE) layer. Based on the mentioned evidence the study designed to evaluate the efficacy and safety of 2-month crocin supplementation (15 mg/d) in 40 patients with CSCR in a randomized controlled blinded clinical trial.

Study Overview

• Status: Recruiting
• Conditions: Chorioretinopathy, Central Serous
• Intervention / Treatment: Drug: Crocin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Recruiting
      • Shiraz University of Medical Sciences
      • Contact: Mojtaba Heydari, M.D.; Phone Number: +989172051798; Email: mheydari@sums.ac.ir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age of 18-60 years old
• The diagnosis of CSCR based on clinical and imagining evaluation
• informed consent

Exclusion Criteria:

• Chronic CSCR
• Laser treatment (6 months prior to enrollment)
• IVB treatment (3 months prior to enrollment)
• Other retinal diseases
• History of eye diseases
• Diabetes Mellitus
• Renal or hepatic diseases
• Allergy to saffron or crocin
• Pregnancy or lactation
• Beta-blocker, diuretic, or corticosteroid (1 week prior to enrollment) Bleeding tendency or any coagulation disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 15 mg/d
Experimental: Crocin	Drug: Crocin; 15 mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Best-corrected visual acuity (BCVA)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foveal thickness (μm)	measured by OCT imaging	8 weeks
Subretinal fluid height (μm)	measured by OCT imaging	8 weeks
Subfoveal choroidal thickness (μm)	measured by OCT imaging	8 weeks
Number of participants need to laser therapy	based on clinical criteria	8 weeks
Total number of reported adverse events	based on patients reported adverse events	8 weeks

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: May 2, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy
• Other Study ID Numbers: 1400.059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No