Diabetic MaculopathyPhase 4NCT06850571
Aflibercept and Bevacizumab for Diabetic Maculopathies
A Phase 4 study testing Bevacizumab Injection [Avastin] and Aflibercept 2Mg/0.05Ml Inj,Oph in people with Diabetic Maculopathy, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetic Maculopathy
- What is being tested?
- Bevacizumab Injection [Avastin] and Aflibercept 2Mg/0.05Ml Inj,Oph
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteIraq
- Study dates
- 20 Feb 2025to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
Baghdad Medical City Complex
Baghdad, 10001
Mahmood Salman, PhD, 7905777486 ext. 00964, ph.mahmoudalrawi@uoanbar.edu.iq
About this study
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
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).
Read the 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
- Being tested
- Bevacizumab Injection [Avastin], Aflibercept 2Mg/0.05Ml Inj,Oph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab Injection [Avastin]Drug
Also called Avastin 100 mg in 4 ml Injection
1.25 mg intravitreal injection given once monthly for three consecutive months.
Aflibercept 2Mg/0.05Ml Inj,OphDrug
Also called EYLEA Bayer
2.0 mg intravitreal injection given once monthly for three consecutive months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Aflibercept 2Mg/0.05Ml Inj,Oph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual accuty assessed by snellen chart
The visual outcomes achieved by testing visual acuity by snellen chart
Measured: 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)
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: one day before start of treatment, and after 3 months of starting the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start20 Feb 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic MaculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Collaborators
- Baghdad Medical City
- Responsible party
- Principal investigator, Mohammed Mahmood Mohammed, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850571
- Sponsor's protocol ID
- UOM4540
- Status last verified
- Sep 2025
- First submitted
- 15 Feb 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06850571
- Acronym / sponsor ID
- UOM4540
- Conditions
- Diabetic Maculopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Collaborators
- Baghdad Medical City
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab group | Active comparator | Drug: Bevacizumab Injection [Avastin]Patients will receive an intravitreal injection of 1.25 mg (in 0.05 ml solution) of bevacizumab once monthly for three consecutive months. |
| Aflibercept group | Experimental | Drug: Aflibercept 2Mg/0.05Ml Inj,OphPatients will receive an intravitreal injection of 2.0 mg (in 0.05 ml solution) of aflibercept once monthly for three consecutive months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab Injection [Avastin]Also: Avastin 100 mg in 4 ml Injection1.25 mg intravitreal injection given once monthly for three consecutive months. | Drug | Bevacizumab group |
| Aflibercept 2Mg/0.05Ml Inj,OphAlso: EYLEA Bayer2.0 mg intravitreal injection given once monthly for three consecutive months. | Drug | Aflibercept group |
Primary outcome
Visual accuty assessed by snellen chart
Time frame: one day before start of treatment, and after 3 months of starting the treatment
The visual outcomes achieved by testing visual acuity by snellen chart
Central fovial thinkness by OCT
Time frame: one day before start of treatment, and after 3 months of starting the treatment
Macular thickness by optical coherence tomography (OCT)
3 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 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)
Time frame: 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)
Time frame: one day before start of treatment, and after 3 months of starting the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Maculopathy
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
Diabetic Retinopathy, Macular Edema
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
Diabetic Retinopathy, Macular Edema
RecruitingObservational study
Blepharoptosis After Repeated Intravitreal Anti-VEGF Injections: A Prospective Study
Blepharoptosis, Age-Related Macular Degeneration
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bevacizumab Injection [Avastin] and Aflibercept 2Mg/0.05Ml Inj,Oph in people with Diabetic Maculopathy, run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual accuty assessed by snellen chart (time frame: one day before start of treatment, and after 3 months of starting the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.