Aflibercept and Bevacizumab for Diabetic Maculopathies
ConditionDiabetic Maculopathy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorAl-Mustansiriyah University
About this trial
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
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Bevacizumab Injection [Avastin]
- Aflibercept 2Mg/0.05Ml Inj,Oph
Treatment groups
102 Participants
are divided into 2 treatment groupsSponsors and collaborators
Al-Mustansiriyah University
Lead sponsor
Baghdad Medical City
Collaborator
Source ClinicalTrials.gov