Comparing Aflibercept and Bevacizumab for Treating Diabetic Maculopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of two medications, aflibercept and bevacizumab, in treating diabetic maculopathy. Participants, aged over 40 with type 2 diabetes and specific visual impairments, will receive three monthly injections of either medication. The study will assess both functional changes in visual acuity and anatomical changes in macular thickness using optical coherence tomography (OCT). Additionally, it will analyze the cost-effectiveness and safety profiles of both treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Baghdad Medical City Complex
  Baghdad, Iraq Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.