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OpenTrials
Completed

NCT Number: NCT05978622

Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant

The dexamethasone 700 μg intravitreal implant (DEX-I) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of DME. This study will assess adult participants with diabetic macular edema (DME) and suboptimal response to anti-vascular endothelial growth factor therapy that are treated with DEX-I in the routine clinical setting.

Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled at approximately 40 sites in approximately 10 countries globally.

Participants will be followed for 18 months post-DEX-I implantation according to the routine clinical practice of the prescribing centers. Only one eye per participant will be evaluated in the study.

No additional burden for participants in this trial is expected.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uza /Id# 255831, Edegem, Antwerpen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation

    Time frame: Baseline to 18 Months

    Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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)

Acronym: P23-380 - INIT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2023
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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