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

NCT06841250 | Enrolling By Invitation DMC FDA Drug

• 1 other identifier: Soh-Med--25-1-08MS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Early OCT Biomarker Changes in Response to Anti-VEGF

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

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

Interventions

intravitreal injection of anti-VEGF PROCEDURE

Ranibizumab is injected into the vitreous under aseptic conditions as part of routine DME treatment

DME patients who are treatment-naïve

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic macular Oedema patients who are treatment naïve.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nada Essam Ahmed

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: January 16, 2025
• Primary Completion: January 16, 2026
• Study Completion: January 16, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

EG (1)