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

NCT06173245 | Completed

• 1 other identifier: MD/AZ.AST./OPH026/2/199/9/2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of visual acuity (VA)

  3 months

Study Arms (1)

Intravitreal injection of ranibizumab

EXPERIMENTAL

These patients were received three intravitreal injection of ranibizumab with one month interval.

Procedure: Intravitreal injection of ranibizumab

Interventions

Intravitreal injection of ranibizumab PROCEDURE

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).

Intravitreal injection of ranibizumab

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Egyptian Biomedical Research Network: lead

Study Sites (1)

Al-Azhar University

Asyut, Egypt

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Ekram R Abd-Allah, Master

  Ophthalmology Department, Faculty of Medicine-Al-Azhar University - Assiut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Ophthalmology at El-Mabra hospital, Faculty of Medicine, Al-Azhar University, Assiut, Egypt.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: February 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)