NCT06850571 Aflibercept and Bevacizumab for Diabetic Maculopathies
| NCT ID | NCT06850571 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Al-Mustansiriyah University |
| Condition | Diabetic Maculopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 102 participants in total. It began in 2025-02-20 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Frequently Asked Questions
Who can join the NCT06850571 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Diabetic Maculopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06850571 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06850571 currently recruiting?
Yes, NCT06850571 is actively recruiting participants. Visit ClinicalTrials.gov or contact Al-Mustansiriyah University to inquire about joining.
Where is the NCT06850571 trial being conducted?
This trial is being conducted at Baghdad, Iraq.
Who is sponsoring the NCT06850571 clinical trial?
NCT06850571 is sponsored by Al-Mustansiriyah University. The trial plans to enroll 102 participants.