Anti-VEGF Therapy
Conditions
Keywords
Diabetic macular edema, Brolucizumab, Aflibercept
Brief 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 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.
Interventions
DRUGIntervention 1: Brolucizumab
Intravitreal injection of Brolucizumab (6 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.
DRUGIntervention 2: Aflibercept
Intravitreal injection of Aflibercept (2 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.
Sponsors
Benha University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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 \[SLE\]).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best-Corrected Visual Acuity (BCVA) from Baseline to 6 Months | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Intravitreal Injections Over 6 Months | From baseline to month 6 | The cumulative number of injections each patient received, to compare treatment burden between groups. |
Countries
Egypt
Outcome results
None listed