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High-Dose eye injection tested against stubborn diabetic swelling

NCT ID NCT06879301

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers at Tanta University are testing whether a high-dose version of the eye injection aflibercept (8 mg) can improve vision in people with diabetic macular edema or retinal vein occlusion that has not responded well to earlier anti-VEGF treatments. The study enrolls 60 adults with these resistant eye conditions. Participants receive the injection directly into the eye under sterile conditions, and researchers track changes in best corrected visual acuity.

What this could mean

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

Active substance
aflibercept 8 mg, a high-dose anti-VEGF eye injection
What this could lead to
If it works, this could offer a stronger treatment option for people whose diabetic macular edema or retinal vein occlusion has not responded well to standard anti-VEGF injections.
What could go wrong
This is an early-phase study with 60 participants, so results may not hold in larger groups. Eye injections carry small risks of infection, bleeding, or increased eye pressure.

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.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

60 people

The number who actually took part.

Started

Mar 2025

Finished

Jul 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.

Ages

20 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: This study included resistant centrally involved diabetic macular edema (DME) cases \- Exclusion Criteria: 1. Patients with a history of intraocular surgery 2. coincident retinal pathology such as retinal vascular occlusion, CNV due to age-related macular degeneration, angioid streaks, trauma, and choroiditis were excluded from the study. 3. patients who received other lines of treatment for DME, such as laser photocoagulation, intravitreal injection of steroids 4. patients known to be glaucomatous or have an IOP ≥20 mmHg were also excluded. \-

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Conditions

The condition(s) this trial relates to.

diabetic macular edema retinal vein occlusion

As listed by the trial registrant

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

Diabetic macular edema (DME) Myopic choroidal neovascularisation Retinal vein occlusion (RVO)

Contacts and locations

Locations

  • faculty of medicine, Tanta University

    Tanta, 1335, Egypt

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