Aflibercept and Bevacizumab for Diabetic Maculopathies

Официальное название

Evaluation of the Clinical Outcomes and Cost-effectiveness of Aflibercept and Bevacizumab in Iraqi Patients With Diabetic Maculopathies: Open Label Parallel Groups Clinical Trial

Обзор

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).

Подробное описание

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

Вмешательства

• Препарат Bevacizumab Injection [Avastin]
  1.25 mg intravitreal injection given once monthly for three consecutive months.
• Препарат Aflibercept 2Mg/0.05Ml Inj,Oph
  2.0 mg intravitreal injection given once monthly for three consecutive months.

Первичные конечные точки

• Visual accuty assessed by snellen chart [Срок оценки: one day before start of treatment, and after 3 months of starting the treatment]
• Central fovial thinkness by OCT [Срок оценки: one day before start of treatment, and after 3 months of starting the treatment]

Вторичные конечные точки (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: one day before start of treatment, and after 3 months of starting the treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Ирак · 1 центр

• Baghdad Medical City Complex — Baghdad

Идентификаторы

NCT: NCT06850571 · UOM4540

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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