Clinical trial NCT06850571: Aflibercept and Bevacizumab for Diabetic Maculopathies
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetic Maculopathy
Lead sponsor: Al-Mustansiriyah University
Sponsor class: OTHER
Collaborators: name: Baghdad Medical City
First posted: 2025-02-27
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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

Primary outcomes:
measure: Visual accuty assessed by snellen chart
timeFrame: one day before start of treatment, and after 3 months of starting the treatment
measure: Central fovial thinkness by OCT
timeFrame: one day before start of treatment, and after 3 months of starting the treatment
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: During the three months after starting the treatment till the end of follow-up.
measure: Quality of life assessed by Visual Functioning Questionnaire 25 (ARB-VFQ-25)
timeFrame: one day before start of treatment, and after 3 months of starting the treatment
measure: Adherence assessed by Adherence Barriers Questionnaire of Intravitreal Therapy (ABQ-IVT)
timeFrame: one day before start of treatment, and after 3 months of starting the treatment
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Baghdad Medical City Complex
Study officials:
References: