Aflibercept and Bevacizumab for Diabetic Maculopathies

NCT ID: NCT06850571

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2025-12-01

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

Conditions

Diabetic Maculopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab group

Patients will receive an intravitreal injection of 1.25 mg (in 0.05 ml solution) of bevacizumab once monthly for three consecutive months.

Group Type: ACTIVE_COMPARATOR

Bevacizumab Injection [Avastin]

Intervention Type: DRUG

1.25 mg intravitreal injection given once monthly for three consecutive months.

Aflibercept group

Patients will receive an intravitreal injection of 2.0 mg (in 0.05 ml solution) of aflibercept once monthly for three consecutive months.

Group Type: EXPERIMENTAL

Aflibercept 2Mg/0.05Ml Inj,Oph

Intervention Type: DRUG

2.0 mg intravitreal injection given once monthly for three consecutive months.

Interventions

Bevacizumab Injection [Avastin]

1.25 mg intravitreal injection given once monthly for three consecutive months.

Intervention Type: DRUG

Aflibercept 2Mg/0.05Ml Inj,Oph

2.0 mg intravitreal injection given once monthly for three consecutive months.

Intervention Type: DRUG

Other Intervention Names

Avastin 100 mg in 4 ml Injection; EYLEA Bayer

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baghdad Medical City

OTHER

Sponsor Role: collaborator

Al-Mustansiriyah University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Mahmood Mohammed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baghdad Medical City Complex

Baghdad, , Iraq

Site Status: RECRUITING

Countries

Iraq

Facility Contacts

Mahmood Salman, PhD

Role: primary

ph.mahmoudalrawi@uoanbar.edu.iq

7905777486 ext. 00964

Other Identifiers

UOM4540

Identifier Type: -

Identifier Source: org_study_id