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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06173245
Enrollment
50
Registered
2023-12-15
Start date
2021-02-01
Completion date
2023-02-01
Last updated
2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy, Intravitreal, Ranibizumab, Subfoveal Choroidal Thickness, Visual Acuity

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.

Interventions

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).

Sponsors

Egyptian Biomedical Research Network
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of subfoveal choroidal thickness (SFCT)3 monthsAll 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

MeasureTime frameDescription
Change of visual acuity (VA)3 monthsRegular measurements of visual acuity (VA) over the evaluation visiting

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026