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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06173245
• Other study ID #: MD/AZ.AST./OPH026/2/199/9/2021
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: December 2023
• Source: Egyptian Biomedical Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Ranibizumab
• Retinal Diseases
• Visual Acuity

Intervention

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).

Locations

Country	Name	City	State
Egypt	Al-Azhar University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Biomedical Research Network

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of visual acuity (VA)	Regular measurements of visual acuity (VA) over the evaluation visiting	3 months