Aflibercept and Bevacizumab for Diabetic Maculopathies

Al-Mustansiriyah University

Status and phase

Enrolling

Phase 4

Conditions

Diabetic Maculopathy

Treatments

Drug: Bevacizumab Injection [Avastin]

Drug: Aflibercept 2Mg/0.05Ml Inj,Oph

Study type

Interventional

Funder types

Other

Identifiers

NCT06850571

UOM4540

Details and patient eligibility

About

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).

Full 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

Enrollment

102 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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