Aflibercept and Bevacizumab for Diabetic Maculopathies

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

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).

Study Overview

• Status: Recruiting
• Conditions: Diabetic Maculopathy
• Intervention / Treatment: Drug: Bevacizumab Injection [Avastin]; Drug: Aflibercept 2Mg/0.05Ml Inj,Oph

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

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 10001
    • Recruiting
    • Baghdad Medical City Complex
    • Contact: Mahmood Salman, PhD; Phone Number: 00964 7905777486; Email: ph.mahmoudalrawi@uoanbar.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Bevacizumab Injection [Avastin]; 1.25 mg intravitreal injection given once monthly for three consecutive months.; Other Names: Avastin 100 mg in 4 ml Injection
Experimental: 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.	Drug: Aflibercept 2Mg/0.05Ml Inj,Oph; 2.0 mg intravitreal injection given once monthly for three consecutive months.; Other Names: EYLEA Bayer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Safety profile and adverse events reported Safety profile and adverse events reported with bevacizumab and aflibercept use and their association with changes in functioning changes.	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)	Quality of life-related to visual functioning will be assessed using the Arabic version of the Visual Functioning Questionnaire 25 (ARB-VFQ-25). The ARB-VFQ-25 will be assessed and validated before the start of data collection.	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)	Assessment and validation of the Arabic version of the Adherence Barriers Questionnaire of Intravitreal Therapy (ABQ-IVT) and studying the barriers to adherence that may affect intravitreal drug use.	one day before start of treatment, and after 3 months of starting the treatment

Collaborators and Investigators

• Sponsor: Al-Mustansiriyah University
• Collaborators: Baghdad Medical City

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: February 22, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Drug Administration Routes; Drug Therapy; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab; Injections; aflibercept
• Other Study ID Numbers: UOM4540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No