Aflibercept and Bevacizumab for Diabetic Maculopathies
Evaluation of the Clinical Outcomes and Cost-effectiveness of Aflibercept and Bevacizumab in Iraqi Patients With Diabetic Maculopathies: Open Label Parallel Groups Clinical Trial
Al-Mustansiriyah University
102 participants
Feb 20, 2025
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria4
- 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 Criteria12
- 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
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Interventions
1.25 mg intravitreal injection given once monthly for three consecutive months.
2.0 mg intravitreal injection given once monthly for three consecutive months.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06850571