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Cheaper eye drug could save sight for millions with diabetes

NCT ID NCT07663370

Disease control Sponsor: Benha University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study examines how well a biosimilar (a lower-cost copy) of the drug ranibizumab works for diabetic macular edema, a condition that causes vision loss in people with diabetes. Researchers will review medical records of 60 adults who received at least one injection of the biosimilar in routine care. They will measure changes in vision and retinal swelling to see if the biosimilar is a safe and effective option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ranibizumab biosimilar
What this could lead to
If effective, this could offer a more affordable treatment option for diabetic macular edema, potentially improving access to care.
What could go wrong
This is a small, retrospective study, so results may not apply to all patients. The biosimilar may not work as well as the original drug in some cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

60 people

The number who actually took part.

Started

Jan 2022

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients with type 1 or type 2 diabetes mellitus diagnosed with center-involving diabetic macular edema confirmed by optical coherence tomography (OCT), who received at least one intravitreal injection of ranibizumab biosimilar at the Retina Unit, Department of Ophthalmology, Benha University Hospitals, between January 2022 and April 2026. Eligible eyes had a minimum follow-up duration of 3-6 months with available baseline and follow-up data for best-corrected visual acuity (BCVA) and central macular thickness (CMT). Patients with other causes of macular edema, prior recent anti-VEGF therapy within the washout period, significant media opacity affecting imaging, coexisting retinal pathology affecting vision, prior vitreoretinal surgery, or incomplete records were excluded. The population reflects a real-world retrospective cohort treated in routine clinical practice.

Ages

Up to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * • Age ≥18 years * Diagnosis of type 1 or type 2 diabetes mellitus * Center-involving diabetic macular edema confirmed by OCT * Received at least one intravitreal ranibizumab biosimilar injection * Minimum follow-up duration of 3-6 months Exclusion Criteria: * • Macular edema due to causes other than diabetes * Prior anti-VEGF treatment within specified washout period * Significant media opacity affecting imaging * Coexisting retinal pathology affecting vision (e.g., AMD, RVO) * Prior vitreoretinal surgery * Incomplete records or inadequate follow-up

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anti-VEGF treatment Biosimilar Ranibizumab

Contacts and locations

Locations

  • Benha University

    Banhā, Benha, 13111, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.