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Steroid implant may beat standard injections for diabetic eye swelling before cataract surgery

NCT ID NCT03832179

Disease control Sponsor: Bay Area Retina Associates 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a steroid implant (Ozurdex) or anti-VEGF injections (Avastin, Lucentis, or Eylea) work better to prevent worsening of diabetic macular edema after cataract surgery. Sixteen adults with diabetes and pre-existing eye swelling received one treatment before surgery. Researchers measured changes in retinal thickness and vision over three months after surgery.

What this could mean

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

Active substance
Bevacizumab, Ranibizumab, Aflibercept (anti-VEGF drugs) or Dexamethasone implant (Ozurdex)
What this could lead to
If it works, this could show that a steroid implant before cataract surgery better controls swelling and vision loss in people with diabetic macular edema.
What could go wrong
This is a very small, completed phase 4 trial with only 16 participants, so results may not apply widely. Both treatments have risks like infection 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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

16 people

The number who actually took part.

Started

Nov 2018

Finished

Mar 2024

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

18 years and older

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: * Age \> 18 years of age * Gender- All * Race- All * Diagnosis of Diabetes (Type 1 or 2) with a concomitant diagnosis of diabetic macular edema as demonstrated on spectral domain optical coherence tomography (Heidelberg Spectralis) * \>250 microns central foveal thickness * Able and willing to provide informed consent Exclusion Criteria: * Significant renal disease * A condition that in the opinion of the investigator would preclude participation * Participation in another investigational trial within 30 days of randomization * Application of focal macular laser within 120 days of enrollment * Administration of Iluvien implant within 3 years of enrollment * Administration of intravitreal triamcinolone within 3 months of enrollment * Administration of any anti-vascular endothelial growth factor agent within 30 days of enrollment * Known hypersensitivity to any of the investigational products * Blood pressure \>180/110 * Women who are pregnant, lactating, or intend to become pregnant within 1 year of randomization * Vulnerable populations- including but not limited to wards of the state, cognitively impaired individuals, prisoners, institutionalized individuals * Individual is planning on moving within 6 months of study enrollment * Macular edema secondary to cause other than diabetic macular edema * Ocular condition that, in the opinion of the investigators, may affect course of macular edema during course of study (vein occlusion, uveitis, etc.) * Evidence of ocular infections * Evidence of uncontrolled glaucoma * Known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or Ozurdex

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Conditions

The condition(s) this trial relates to.

cataract diabetic macular edema

As listed by the trial registrant

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

Cataract Diabetic macular edema

Contacts and locations

Locations

  • Bay Area Retina Associates

    Walnut Creek, California, 94598, United States

More trials for these conditions

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