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Observational assessment of Dexamethasone implant in adults with Diabetic Macular Edema

A Multi-country, Post Marketing Observational Study of DME Patients With Suboptimal Response to Anti-VEGF Who Are Initiated With Dexamethasone Intravitreal Implant (DEX-I)

Observational AbbVie · NCT05978622

This study is testing whether a dexamethasone implant can help adults with diabetic macular edema who haven't responded well to other treatments.

Quick facts

Study typeObservational
Enrollment327 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Locations52 sites (Edegem, Antwerpen and 51 other locations)
Trial IDNCT05978622 on ClinicalTrials.gov

What this trial studies

This observational study evaluates adult participants diagnosed with diabetic macular edema (DME) who have shown a suboptimal response to anti-vascular endothelial growth factor (anti-VEGF) therapy. Participants will receive a dexamethasone intravitreal implant (DEX-I), which gradually delivers medication to the retina, and will be monitored for 18 months in a routine clinical setting. The study aims to gather data on the effectiveness of DEX-I in improving outcomes for these patients across approximately 40 sites in 10 countries. Only one eye per participant will be assessed, and no additional burdens are expected for participants.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with DME who have received between 3 to 9 anti-VEGF injections in the past year and are newly prescribed DEX-I.

Not a fit: Patients with significant ocular conditions, recent ocular surgeries, or uncontrolled ocular hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into improved treatment options for patients with DME who do not respond adequately to current therapies.

How similar studies have performed: Previous studies have shown promise in using dexamethasone implants for DME, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant diagnosed with DME in the study eye
* Study eye has received at least 3 and no more than 9 anti-VEGF injections in the 12 months prior to DEX-I initiation
* Study eye newly prescribed DEX-I. The prescribing decision lies with the physician and reflects their standard practice
* Participant showing a suboptimal response to anti-VEGF at Baseline in the study eye

Exclusion Criteria:

* Any concomitant ocular or neurologic condition in the study eye that could cause macular edema or affect vision (except cataract)
* History of ocular surgery within 60 days of Baseline in the study eye
* History of Pan-Retinal Photocoagulation (PRP) or sectorial photocoagulation in the study eye in the 3 months prior to Baseline
* Significant media opacities in the study eye limiting Optical Coherence Tomography (OCT) quality
* Uncontrolled Ocular Hypertension (OHT) or advanced glaucoma in the study eye
* Active ocular inflammation in either eye
* Study eyes that are aphakic with Posterior Capsule Rent (PCR), Anterior Chamber Intraocular Lens (ACIOL), iris or scleral-fixed Intraocular Lens (IOL) or history of complicated cataract surgery with PCR
* Prior use of intravitreal corticosteroids in the study eye
* Patients with contraindications to DEX-I

Where this trial is running

Edegem, Antwerpen and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Macular EdemaDMEDexamethasoneDexamethasone Intravitreal ImplantOzurdex
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.