Clinical trial NCT06173245: Subfoveal Choroidal Thickness and Visual Acuity After Intravitreal Injection of Ranibizumab in Diabetic Retinopathy
Official title: The Change of Subfoveal Choroidal Thickness After Intravitreal Injection of Ranibizumab and Its Correlation With Visual Acuity in Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subfoveal Choroidal Thickness
Intravitreal
Ranibizumab
Visual Acuity
Diabetic Retinopathy
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2023-12-15
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of subfoveal choroidal thickness (SFCT)
timeFrame: 3 months
Secondary outcomes:
measure: Change of visual acuity (VA)
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Al-Azhar University
Study officials:
affiliation: Ophthalmology Department, Faculty of Medicine-Al-Azhar University - Assiut
name: Ekram R Abd-Allah, Master
role: PRINCIPAL_INVESTIGATOR
References: