Aflibercept and Bevacizumab for Diabetic Maculopathies
Recruiting
Phase 4Interventional Study
Diabetic Maculopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
102 (estimated)
Sponsor
Al-Mustansiriyah University · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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Status
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 vi…
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
Contacts
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