A Phase 4 interventional study of Ranibizumab and Aflibercept in Diabetic Macular Edema, sponsored by Benha University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Benha University · Phase 4, Interventional, and Treatment
Diabetic macular edema (DME) is a complication of diabetes that causes fluid accumulation in the central retina, potentially leading to impaired vision. Intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) medications, including ranibizumab and aflibercept, are commonly used to treat this condition.
This prospective, randomized, comparative study aimed to evaluate and compare the effects of intravitreal ranibizumab and aflibercept on macular vascular density in patients with diabetic macular edema using optical coherence tomography angiography (OCTA), a noninvasive imaging technique that visualizes retinal blood vessels.
The study included 80 eyes with diabetic macular edema, randomly assigned to two equal treatment groups. One group received ranibizumab, while the other received aflibercept. Each eye received three intravitreal injections. Changes in retinal vascular density, central retinal thickness, and visual acuity were assessed at baseline, 3 months, and 6 months.
The study aimed to determine whether OCTA measurements could help evaluate treatment response and identify vascular changes associated with improvement in diabetic macular edema.
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
This study's enrollment of 80 is above the median of 56 across 584 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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This arm included 40 eyes with diabetic macular edema treated with intravitreal ranibizumab (0.5 mg/0.05 mL). Each eye received three intravitreal injections under sterile conditions. Patients underwent regular ophthalmic examinations, with best-corrected visual acuity, central retinal thickness, and optical coherence tomography angiography parameters assessed at baseline, 3 months, and 6 months.
Drug: Ranibizumab
This arm included 40 eyes with diabetic macular edema treated with intravitreal aflibercept (2 mg/0.05 mL). Each eye received three intravitreal injections under sterile conditions. Patients underwent regular ophthalmic examinations, with best-corrected visual acuity, central retinal thickness, and optical coherence tomography angiography parameters assessed at baseline, 3 months, and 6 months.
Drug: Aflibercept
Ranibizumab is a recombinant humanized monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A), reducing vascular permeability and retinal fluid accumulation in patients with diabetic macular edema.
Aflibercept is a recombinant fusion protein that acts as a soluble decoy receptor for vascular endothelial growth factor A (VEGF-A), VEGF-B, and placental growth factor (PlGF), inhibiting abnormal vascular permeability and reducing retinal edema in patients with diabetic macular edema.
Change in Macular Vascular Density Assessed by Optical Coherence Tomography Angiography
Changes in whole-image and foveal vascular density (%) of the superficial capillary plexus (SCP) and deep capillary plexus (DCP) were assessed using optical coherence tomography angiography (OCTA). Vascular density was measured at baseline, 3 months, and 6 months to evaluate and compare the effects of intravitreal ranibizumab and aflibercept in patients with diabetic macular edema.
Time frame: Baseline, 3 months, and 6 months after the first injection
Central Retinal Thickness (CRT)
Central retinal thickness was measured in micrometers (µm) using optical coherence tomography (OCT). Changes from baseline were evaluated at 3 and 6 months to assess anatomical improvement following intravitreal ranibizumab or aflibercept treatment.
Time frame: Baseline, 3 months, and 6 months after the first injection
Change in Best-Corrected Visual Acuity (BCVA)
Best-corrected visual acuity was assessed using a Snellen visual acuity chart and converted to logarithm of the minimum angle of resolution (LogMAR) values. Changes from baseline were evaluated at 3 and 6 months to assess functional visual improvement following treatment.
Time frame: Baseline, 3 months, and 6 months after the first injection
Change in Intraocular Pressure (IOP)
Intraocular pressure was measured in millimeters of mercury (mmHg) using Goldmann applanation tonometry. Changes in intraocular pressure were evaluated during follow-up to assess ocular safety following intravitreal injections.
Time frame: Baseline, 3 months, and 6 months after the first injection
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ranibizumab · Aflibercept