Comparing Aflibercept and Bevacizumab for Treating Diabetic Maculopathy
Evaluation of the Clinical Outcomes and Cost-effectiveness of Aflibercept and Bevacizumab in Iraqi Patients With Diabetic Maculopathies: Open Label Parallel Groups Clinical Trial
PHASE4 · Al-Mustansiriyah University · NCT06850571
This study is testing whether two eye injections, aflibercept and bevacizumab, can help improve vision in people over 40 with type 2 diabetes and certain vision problems.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Al-Mustansiriyah University (other) |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (Baghdad) |
| Trial ID | NCT06850571 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals over 40 years old with type 2 diabetes and diagnosed diabetic maculopathy showing reduced vision and significant foveolar thickening.
Not a fit: Patients with type 1 diabetes, those on insulin therapy, or individuals with recent treatments for diabetic maculopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment for improving vision in patients with diabetic maculopathy.
How similar studies have performed: Other studies have shown varying success with anti-VEGF treatments for diabetic maculopathy, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baghdad
- Baghdad Medical City Complex — Baghdad, Iraq (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Maculopathy