Subfoveal Choroidal Thickness and Visual Acuity After Intravitreal Injection of Ranibizumab in Diabetic Retinopathy

The Change of Subfoveal Choroidal Thickness After Intravitreal Injection of Ranibizumab and Its Correlation With Visual Acuity in Diabetic Retinopathy

The aim of this study is to compare subfoveal choroidal thickness (SFCT) and the visual status before and after intravitreal injection of ranibizumab in diabetic macular edema (DME) with the use of 3D-OCT by enhanced depth spectral-domain imaging (EDI-OCT) with fixating other factors.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy; Visual Acuity; Ranibizumab; Subfoveal Choroidal Thickness; Intravitreal
• Intervention / Treatment: Procedure: Intravitreal injection of ranibizumab

Detailed Description

Diabetes is a metabolic disorder affecting the ocular vasculature. Although the principal posterior segment changes in diabetes usually occur in the retinal vasculature, additional changes are also observed in the choroid which provides an important blood supply to the outer retina. Diabetic choroidopathy involves choroidal abnormalities occurring in diabetic patients and may participate in mechanisms that lead to the decrease of visual acuity.

Several studies demonstrated the possibility of imaging of the choroid using spectral-domain OCT. Many studies investigated variation in the choroidal thickness (CT) occurring with changes in age and axial length, or in different ocular diseases, Diabetic macular edema (DME) is a major cause of visual loss in diabetic patients.

OCT (Optical coherence tomography) is a non-invasive imaging technique, that was used to obtain a high definition segments of retina. Lately, EDI (enhanced depth imaging) spectral-domain OCT has been explained. (EDI) program routinely captures a cross sectional picture with the choroid near the zero delay line to enhance sensitivity on the external edge of the choroid.

Functional imaging findings also presented a decrease in choroidal flow of the blood in eyes with diabetic retinopathy.

The current purpose of (EDI-OCT), which employing the enhanced depth of field from the inverted picture by locating the OCT device near to the eye, has helped the researchers to study the anatomic variations in the choroid in diabetic eyes.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 50 to 70 years.
• Both sexes.
• Patients suffering from diabetic macular edema (DME).

Exclusion Criteria:

• High myopia more than 6 diopters.
• previous injections or retinal surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intravitreal injection of ranibizumab; These patients were received three intravitreal injection of ranibizumab with one month interval.

Procedure: Intravitreal injection of ranibizumab; These patients were received three intravitreal injection of ranibizumab with one month interval. 3D-OCT by enhanced depth spectral-domain imaging (EDI-OCT) was done preoperative and a month after every injection. All patients recieved topical anesthesia as 0.5 mg/0.05 ml , ranibizumab is injected 4 mm (3.5 mm in Pseudophakia) from the limbus intravitreally (in the lower temporal quadrant) by a needle (27gauge).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of subfoveal choroidal thickness (SFCT)	All patients will be scheduled for subfoveal choroidal thickness (SFCT) evaluation on the first month, two month and three months by Optical coherence tomography (OCT).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of visual acuity (VA)	Regular measurements of visual acuity (VA) over the evaluation visiting	3 months

Collaborators and Investigators

• Sponsor: Egyptian Biomedical Research Network
• Investigators: Principal Investigator: Ekram R Abd-Allah, Master, Ophthalmology Department, Faculty of Medicine-Al-Azhar University - Assiut

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: MD/AZ.AST./OPH026/2/199/9/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No