Aflibercept and Bevacizumab for Diabetic Maculopathies

Recruiting now · Phase 4

Conditions studied: Diabetic Maculopathy

In brief

The goal of this clinical trial is to to evaluate the clinical outcomes following treatment with bevacizumab versus aflibercept. These outcomes include: * Functional changes: The visual outcomes achieved by testing visual acuity * Anatomical changes: macular thickness and edema by optical coherence tomography (OCT).

Key facts

Study ID

NCT06850571

Run by

Al-Mustansiriyah University

People needed

102

Starts

2025-02-20

Expected to finish

2025-12-01

Last updated by the study team

2025-09-19

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with type 2 diabetes mellites.
• Patients diagnosed with diabetic maculopathies, including focal and diffuse maculopathies, according to Early Treatment of Diabetic Retinopathy Study (ETDRS) criteria
• Patients with reduced or reduced vision (6/9-6/90) according to visual acuity and significant foveolar thickening on OCT (more than 250 μm)
• Patients will be treated with intravitreal anti-VEGF treatment, aflibercept, or bevacizumab for three successive monthly injections.

You may not qualify if…

• Patients with type 1 diabetes mellites
• Patients with type 2 on insulin therapy.
• Patients who were previously treated with intravitreal anti-VEGF within the previous three months or intravitreal corticosteroids for six months
• Prior macular photocoagulation or photodynamic therapy, prior intraocular surgeries within three months (laser \& surgery may cause edema)
• Pregnant or nursing women
• In patients with a history of thromboembolic events, systemic VEGF inhibition is likely to cause cardiovascular complications, such as arterial thromboembolic events.
• Patients major surgery within the previous one year or planned within the next few months that may interfere with anti-VEGF treatment
• Uncontrolled hypertension as hypertension is associated with the use of VEGF antagonists.
• Known coagulation abnormalities or current use of anticoagulative medication other than aspirin.
• Hemorrhagic macular infarction is reported with the use of VEGF antagonists.
• Patients with intraocular pressure more than 25 mmHg
• Presence of iris neovascularization/vitreous hemorrhage

Where it is running

• Baghdad Medical City Complex — Baghdad, Iraq (enrolling)

Full record on ClinicalTrials.gov

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