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

Not Applicable

Completed

• Conditions: Diabetic Retinopathy; Intravitreal; Subfoveal Choroidal Thickness; Ranibizumab; Visual Acuity
• Interventions: Procedure: Intravitreal injection of ranibizumab

• Registration Number: NCT06173245
• Lead Sponsor: Egyptian Biomedical Research Network

Brief Summary

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.

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 Timeline

• Study Start: 2021-02-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-15
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravitreal injection of ranibizumab	Intravitreal injection of ranibizumab	These patients were received three intravitreal injection of ranibizumab with one month interval.

Primary Outcome Measures

Name	Time	Method
Change of subfoveal choroidal thickness (SFCT)	3 months	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).

Secondary Outcome Measures

Name	Time	Method
Change of visual acuity (VA)	3 months	Regular measurements of visual acuity (VA) over the evaluation visiting

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Assiut, Egypt