Aflibercept and Bevacizumab for Diabetic Maculopathies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bevacizumab Injection [Avastin], Aflibercept 2Mg/0.05Ml Inj,Oph.
- Who it may be relevant to
- Registry conditions: Diabetic Maculopathy. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Clinical Outcomes and Cost-effectiveness of Aflibercept and Bevacizumab in Iraqi Patients With Diabetic Maculopathies: Open Label Parallel Groups Clinical Trial
Overview
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).
Detailed description
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
Interventions
- Drug Bevacizumab Injection [Avastin]
1.25 mg intravitreal injection given once monthly for three consecutive months. - Drug Aflibercept 2Mg/0.05Ml Inj,Oph
2.0 mg intravitreal injection given once monthly for three consecutive months.
Primary outcome measures
- Visual accuty assessed by snellen chart [Time frame: one day before start of treatment, and after 3 months of starting the treatment]
- Central fovial thinkness by OCT [Time frame: one day before start of treatment, and after 3 months of starting the treatment]
Secondary outcome measures (3)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [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) [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) [Time frame: one day before start of treatment, and after 3 months of starting the treatment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Iraq · 1 center
- Baghdad Medical City Complex — Baghdad
Identifiers
NCT: NCT06850571 · UOM4540