Early Changes in OCT Biomarkers After the First Intravitreal Anti-VEGF Injection in Treatment-naïve DME

A retrospective, observational, hospital-based study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt.

Study Overview

• Status: Enrolling by invitation
• Conditions: Early OCT Biomarker Changes in Response to Anti-VEGF
• Intervention / Treatment: Procedure: intravitreal injection of anti-VEGF

Detailed Description

Aim of the work To evaluate early changes in OCT biomarkers and visual acuity in treatment-naïve patients with diabetic macular oedema after the first intravitreal antiVEGF injection.

Patients and methods Study Design A retrospective, observational, hospital-based study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt.

Patients This study will include 50 eyes with center-involving DME (CI-DME) of patients who received their 1st AntiVEGF injection as a routine treatment in the Department of Ophthalmology, Sohag University Hospital.

Inclusion Criteria

1. Diabetic patients with center-involving DME (CI-DME) who are treatment-naïve.
2. Central macular thickness (CMT) of 300 microns or more will be accepted as CI-DME.

Exclusion Criteria

1. Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous opacities, etc).
2. Patients with any other retinal vascular diseases (retinal vein occlusion, central serrous chorioretinopathy, age-related macular degeneration, etc).
3. Patients who have had previous intravitreal injections or Laser treatment.
4. Patients who underwent previous vitreoretinal surgeries.
5. Patients with recent history of undergoing cataract surgery.
6. Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis). 4

Methods

We will analyze the medical records of the study participants before and after injection and the collected data will include:

A. History:

Patient age, gender, duration and treatment of diabetes mellitus, visual impairment history, ocular/systemic comorbidities, topical/systemic drug intake, previous ocular/systemic interventional procedures or surgery.

B. Medical Examination and Laboratory investigations:

Blood Pressure, Lipid profile, HbA1c will be measured.

C. Full ophthalmological examination:

Data recorded from the preoperative ophthalmic examination of the studied eye, which includes:

1. Best corrected visual acuity (BCVA): Snellen visual acuities will be presented as Snellen decimal notation.
2. Intraocular pressure (IOP) measured by I-Care rebound tonometer.
3. Slit lamp examination of the anterior segment and angle of the anterior chamber.
4. Fundus examination by indirect ophthalmoscope and slit lamp biomicroscopy with documentation of the stage of diabetic retinopathy.

D. OCT imaging:

OCT images and data will be collected and analysed from the electronic medical reports for all patients at 3 points:

1. Before injection (within one week before the procedure).
2. Two weeks after injection.
3. One month after injection. 5

The collected OCT data will include the following biomarkers:

• Determining the type of DME (diffuse, cystoid, serous retinal detachment).
• Mean central subfield thickness (CST).
• Presence, location and height of macular Intraretinal cystoid spaces (ICS).
• Presence of Subfoveal neuroretinal detachment (SND) and height of serous macular detachment.
• The presence and size, and localization of hyperreflective foci (HF) within the retina.
• The disorganisation of the inner retinal layers (DRIL).
• The presence of vitreomacular traction.
• The integrity of the outer retinal layers, (ellipsoid zone (EZ) and external limiting membrane (ELM)).

E. Theinjectionprocedure:

The surgical notes will be reviewed from the patient's files to report the injection procedure, preparations and complications.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Diabetic macular Oedema patients who are treatment naïve.

Description

Inclusion Criteria:

• Diabetic patients with centre-involving DME (CI-DME) who are treatment-naïve.
• Central macular thickness (CMT) of 300 microns or more will be accepted as DME.

Exclusion Criteria:

• Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous opacities, etc).
• Patients with any other retinal vascular diseases (retinal vein occlusion, central serrous chorioretinopathy, age-related macular degeneration, etc).
• Patients who have had previous intravitreal injections or Laser treatment.
• Patients who underwent previous vitreoretinal surgeries.
• Patients with recent history of undergoing cataract surgery.
• Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

DME patients who are treatment-naïve; The collected OCT data will include the following biomarkers: Determining the type of DME (diffuse, cystoid, serous retinal detachment).; Mean central subfield thickness (CST).; Presence, location and height of macular Intraretinal cystoid spaces (ICS).; Presence of Subfoveal neuroretinal detachment (SND) and height of serous macular detachment.; The presence and size, and localization of hyperreflective foci (HF) within the retina.; The disorganisation of the inner retinal layers (DRIL).; The presence of vitreomacular traction.; The integrity of the outer retinal layers, (ellipsoid zone (EZ) and external limiting membrane (ELM)).

Procedure: intravitreal injection of anti-VEGF; Ranibizumab is injected into the vitreous under aseptic conditions as part of routine DME treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Visual acuity assessment pre and post injection will be recorded	one month
Central subfield thickness	Central subfield thickness assessment pre and post injection will be recorded	one month
Intraretinal cystoid spaces	Intraretinal cystoid space location, size and bridging will be recorded pre and post injection	one month
Subfoveal neuroretinal detatchment	Presence and extent of Subfoveal neuroretinal detatchment assessed pre and post injection will be recorded	one month
Hyperreflective foci	number and locatio of Hyperreflective foci assessed pre and post injection will be recorded	one month
Outer retinal layer integrity	Outer retinal layer integrity assessment pre and post injection will be recorded	one month
Disorganised inner retinal layers	Disorganised inner retinal layers assessment pre and post injection will be recorded	one month

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): January 16, 2026
• Study Completion (Estimated): January 16, 2026

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med--25-1-08MS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes