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).
Brief summary template 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). The secondary objectives include: * Analyze the cost-effectiveness of bevacizumab versus aflibercept in the management of diabetic maculopathies. * Safety profile and adverse events reported with bevacizumab and aflibercept use and their association with changes functioning changes Patients inclusion criteria include patients both sexes, age over 40 years with type 2 diabetes mellites diagnosed with diabetic maculopathies; those patients with reduced or reducing vision (6/9-6/90) according to visual acuity and significant foveolar thickening on OCT (more than 250 μm). Researchers will compare patients with intravitreal anti-VEGF treatment, aflibercept or bevacizumab for three successive monthly injections to see if there are any differences in safety and efficacy between the two arms. Participants will take aflibercept or bevacizumab intravitreally every month for 3 months Visit the clinic once every 1 month for checkups and assessment the pre- and post- 3 month anti-VEGF treatment values and findings by: * Pneumotonometry will be used to measure intraocular pressure (IOP) * Central foveal thickness (CFT) will be measured by optical coherence tomography (OCT). * Visual acuity (by Snellen visual acuity chart) will be assessed. * Pretreatment serum VEGF levels and 7-days after the third anti-VEGF dose
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
1.25 mg intravitreal injection given once monthly for three consecutive months.
2.0 mg intravitreal injection given once monthly for three consecutive months.
Baghdad Medical City Complex
Baghdad, Iraq
RECRUITINGVisual accuty assessed by snellen chart
The visual outcomes achieved by testing visual acuity by snellen chart
Time frame: one day before start of treatment, and after 3 months of starting the treatment
Central fovial thinkness by OCT
Macular thickness by optical coherence tomography (OCT)
Time frame: one day before start of treatment, and after 3 months of starting the treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety profile and adverse events reported Safety profile and adverse events reported with bevacizumab and aflibercept use and their association with changes in functioning changes.
Time frame: During the three months after starting the treatment till the end of follow-up.
Quality of life assessed by Visual Functioning Questionnaire 25 (ARB-VFQ-25)
Quality of life-related to visual functioning will be assessed using the Arabic version of the Visual Functioning Questionnaire 25 (ARB-VFQ-25). The ARB-VFQ-25 will be assessed and validated before the start of data collection.
Time frame: one day before start of treatment, and after 3 months of starting the treatment
Adherence assessed by Adherence Barriers Questionnaire of Intravitreal Therapy (ABQ-IVT)
Assessment and validation of the Arabic version of the Adherence Barriers Questionnaire of Intravitreal Therapy (ABQ-IVT) and studying the barriers to adherence that may affect intravitreal drug use.
Time frame: one day before start of treatment, and after 3 months of starting the treatment
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