Anti-VEGF TherapyAnti-VEGFNCT07096713
Brolucizumab Versus Aflibercept on Visual and Anatomical Outcomes in Diabetic Macular Edema
A study testing Intervention 1: Brolucizumab and Intervention 2: Aflibercept in people with Anti-VEGF Therapy, run by Benha University at 1 site in Egypt.
Trial summary
This retrospective, comparative cohort study included 38 eyes from 38 patients with center-involving diabetic macular edema (DME), treated at Benha University Hospital. Patients were divided into two groups: 19 eyes received intravitreal Brolucizumab (6 mg), and 19 eyes received intravitreal Aflibercept (2 mg), with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anti-VEGF Therapy
- What is being tested?
- Intervention 1: Brolucizumab and Intervention 2: Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with center-involving diabetic macular edema (DME) confirmed by spectral-domain optical coherence tomography (SD-OCT).
- Central macular thickness (CMT) > 350 µm at baseline.
- Treatment-naïve patients (no prior intravitreal injections or laser therapy for DME).
Who cannot join
- Patients with media opacity (e.g., corneal opacities, dense vitreous hemorrhage).
- Significant cataract affecting visual acuity or OCT imaging quality.
- Traction maculopathy or vitreomacular traction.
- Central macular thickness < 350 µm at baseline.
- History of vasculitis or autoimmune diseases (e.g., systemic lupus erythematosus [SLE]).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy and Safety of Brolucizumab Versus Aflibercept on Visual and Anatomical Outcomes in Diabetic Macular Edema: A Retrospective Comparative Study
This retrospective, comparative cohort study included 38 eyes from 38 patients with center-involving diabetic macular edema (DME), treated at Benha University Hospital. Patients were divided into two groups: 19 eyes received intravitreal Brolucizumab (6 mg), and 19 eyes received intravitreal Aflibercept (2 mg), with the aim of comparing their efficacy and safety over a 6-month period.
Read the detailed description
The study retrospectively evaluated real-world outcomes of anti-VEGF therapy in treatment-naïve patients with center-involving DME. Participants were assigned into two equal groups based on the anti-VEGF agent received: Group A was treated with intravitreal Brolucizumab (6 mg), and Group B with intravitreal Aflibercept (2 mg). All patients underwent comprehensive ophthalmic evaluation at baseline and at monthly intervals, including best-corrected visual acuity (BCVA) assessment and optical coherence tomography (OCT) to monitor central retinal thickness (CRT). The primary outcomes were changes in BCVA and CRT from baseline to 6 months, while secondary outcomes included the number of injections received and any adverse events. This study aimed to provide comparative insights into the efficacy, anatomical response, and safety profile of the two anti-VEGF agents in managing DME in a real-world clinical setting.
- Conditions
- Anti-VEGF Therapy
- Being tested
- Intervention 1: Brolucizumab, Intervention 2: Aflibercept
- Keywords
- Diabetic macular edema, Brolucizumab, Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: BrolucizumabDrug
Intravitreal injection of Brolucizumab (6 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.
Intervention 2: AfliberceptDrug
Intravitreal injection of Aflibercept (2 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Brolucizumab Group | Experimental | Description:
This group included 19 eyes of 19 patients who received intravitreal Brolucizumab (6 mg/0.05 mL) injections for center-involving diabetic macular edema.
Intervention Type: Drug
Intervention Name: Brolucizumab 6 mg
Dose/Frequency: Administered intravitreally as needed based on clinical evaluation Receives: Drug: Intervention 1: Brolucizumab |
| Arm 2: Aflibercept Group | Active comparator | This group included 19 eyes of 19 patients who received intravitreal Aflibercept (2 mg/0.05 mL) injections for center-involving diabetic macular edema.
Intervention Type: Drug
Intervention Name: Aflibercept 2 mg
Dose/Frequency: Administered intravitreally as needed based on clinical evaluation Receives: Drug: Intervention 2: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best-Corrected Visual Acuity (BCVA) from Baseline to 6 Months
Measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or Snellen equivalent, converted to logMAR. The primary measure is the mean change in BCVA after treatment with either Brolucizumab or Aflibercept.
Measured: Baseline and 6 months
Change in Central Retinal Thickness (CRT) from Baseline to 6 Months
Assessed by spectral-domain optical coherence tomography (SD-OCT). The outcome is the mean change in CRT in micrometers, reflecting anatomical response to treatment.
Measured: Baseline and 6 months
Secondary outcomes (1)
Total Number of Intravitreal Injections Over 6 Months
The cumulative number of injections each patient received, to compare treatment burden between groups.
Measured: From baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jan 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-VEGF TherapyStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This retrospective comparative cohort study aims to evaluate the efficacy and safety of intravitreal Brolucizumab versus Aflibercept in patients with center-involving diabetic macular edema (DME). A total of 38 eyes from 38 patients treated at Benha University Hospital between January 2023 and June 2024 were included. Patients were divided into two equal groups based on the anti-VEGF agent received: 19 eyes were treated with Brolucizumab 6 mg, and 19 eyes with Aflibercept 2 mg. The study compares visual acuity, central retinal thickness, number of injections, and adverse events over a 6-month follow-up.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096713
- Sponsor's protocol ID
- Brolucizumab Vs Aflibercept
- Acronym
- Anti-VEGF
- Status last verified
- Jan 2023
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Brolucizumab Versus Aflibercept on Visual and Anatomical Outcomes in Diabetic Macular Edema: A Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT07096713
- Acronym / sponsor ID
- Anti-VEGF / Brolucizumab Vs Aflibercept
- Conditions
- Anti-VEGF Therapy
- Keywords
- Diabetic macular edema, Brolucizumab, Aflibercept
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 31 Jul 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.
This retrospective, comparative cohort study included 38 eyes from 38 patients with center-involving diabetic macular edema (DME), treated at Benha University Hospital. Patients were divided into two groups: 19 eyes received intravitreal Brolucizumab (6 mg), and 19 eyes received intravitreal Aflibercept (2 mg), with the aim of comparing their efficacy and safety over a 6-month period.
Detailed description
The study retrospectively evaluated real-world outcomes of anti-VEGF therapy in treatment-naïve patients with center-involving DME. Participants were assigned into two equal groups based on the anti-VEGF agent received: Group A was treated with intravitreal Brolucizumab (6 mg), and Group B with intravitreal Aflibercept (2 mg). All patients underwent comprehensive ophthalmic evaluation at baseline and at monthly intervals, including best-corrected visual acuity (BCVA) assessment and optical coherence tomography (OCT) to monitor central retinal thickness (CRT). The primary outcomes were changes in BCVA and CRT from baseline to 6 months, while secondary outcomes included the number of injections received and any adverse events. This study aimed to provide comparative insights into the efficacy, anatomical response, and safety profile of the two anti-VEGF agents in managing DME in a real-world clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This retrospective comparative cohort study aims to evaluate the efficacy and safety of intravitreal Brolucizumab versus Aflibercept in patients with center-involving diabetic macular edema (DME). A total of 38 eyes from 38 patients treated at Benha University Hospital between January 2023 and June 2024 were included. Patients were divided into two equal groups based on the anti-VEGF agent received: 19 eyes were treated with Brolucizumab 6 mg, and 19 eyes with Aflibercept 2 mg. The study compares visual acuity, central retinal thickness, number of injections, and adverse events over a 6-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Brolucizumab Group | Experimental | Drug: Intervention 1: BrolucizumabDescription: This group included 19 eyes of 19 patients who received intravitreal Brolucizumab (6 mg/0.05 mL) injections for center-involving diabetic macular edema. Intervention Type: Drug Intervention Name: Brolucizumab 6 mg Dose/Frequency: Administered intravitreally as needed based on clinical evaluation |
| Arm 2: Aflibercept Group | Active comparator | Drug: Intervention 2: AfliberceptThis group included 19 eyes of 19 patients who received intravitreal Aflibercept (2 mg/0.05 mL) injections for center-involving diabetic macular edema. Intervention Type: Drug Intervention Name: Aflibercept 2 mg Dose/Frequency: Administered intravitreally as needed based on clinical evaluation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with center-involving diabetic macular edema (DME) confirmed by spectral-domain optical coherence tomography (SD-OCT).
- Central macular thickness (CMT) > 350 µm at baseline.
- Treatment-naïve patients (no prior intravitreal injections or laser therapy for DME).
Key exclusion criteria (5 listed)
- Patients with media opacity (e.g., corneal opacities, dense vitreous hemorrhage).
- Significant cataract affecting visual acuity or OCT imaging quality.
- Traction maculopathy or vitreomacular traction.
- Central macular thickness < 350 µm at baseline.
- History of vasculitis or autoimmune diseases (e.g., systemic lupus erythematosus [SLE]).
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 |
|---|---|---|
| Intervention 1: BrolucizumabIntravitreal injection of Brolucizumab (6 mg/0.05 mL) for the treatment of center-involving diabetic macular edema. | Drug | Arm 1: Brolucizumab Group |
| Intervention 2: AfliberceptIntravitreal injection of Aflibercept (2 mg/0.05 mL) for the treatment of center-involving diabetic macular edema. | Drug | Arm 2: Aflibercept Group |
Primary outcome
Change in Best-Corrected Visual Acuity (BCVA) from Baseline to 6 Months
Time frame: Baseline and 6 months
Measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or Snellen equivalent, converted to logMAR. The primary measure is the mean change in BCVA after treatment with either Brolucizumab or Aflibercept.
Change in Central Retinal Thickness (CRT) from Baseline to 6 Months
Time frame: Baseline and 6 months
Assessed by spectral-domain optical coherence tomography (SD-OCT). The outcome is the mean change in CRT in micrometers, reflecting anatomical response to treatment.
1 secondary outcome
Total Number of Intravitreal Injections Over 6 Months
Time frame: From baseline to month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1: Brolucizumab and Intervention 2: Aflibercept in people with Anti-VEGF Therapy, run by Benha University at 1 site in Egypt.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 31 Jul 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best-Corrected Visual Acuity (BCVA) from Baseline to 6 Months (time frame: Baseline and 6 months). 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 31 Jul 2025.