Aflibercept and Bevacizumab for Diabetic Maculopathies

NCT06850571 | Recruiting Phase 4 DMC

• 1 other identifier: UOM4540
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Maculopathy

Outcome Measures

Primary Outcomes (2)

• Visual accuty assessed by snellen chart

  The visual outcomes achieved by testing visual acuity by snellen chart

  one day before start of treatment, and after 3 months of starting the treatment

• Central fovial thinkness by OCT

  Macular thickness by optical coherence tomography (OCT)

  one day before start of treatment, and after 3 months of starting the treatment

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  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)

  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)

  one day before start of treatment, and after 3 months of starting the treatment

Study Arms (2)

Bevacizumab group

ACTIVE COMPARATOR

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

Drug: Bevacizumab Injection [Avastin]

Aflibercept group

EXPERIMENTAL

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

Drug: Aflibercept 2Mg/0.05Ml Inj,Oph

Interventions

Bevacizumab Injection [Avastin] DRUG

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

Also known as: Avastin 100 mg in 4 ml Injection

Bevacizumab group

Aflibercept 2Mg/0.05Ml Inj,Oph DRUG

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

Also known as: EYLEA Bayer

Aflibercept group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Mustansiriyah University: lead
• Baghdad Medical City: collaborator

Study Sites (1)

Baghdad Medical City Complex

Baghdad, 10001, Iraq

RECRUITING

MeSH Terms

Interventions

Bevacizumab; Injections; aflibercept

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 27, 2025
• Study Start: February 20, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

IR (1)