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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05978622

Acronym

P23-380 - INIT

Enrollment

236

Registered

2023-08-07

Start date

2023-10-30

Completion date

2026-08-13

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema, DME, Dexamethasone, Dexamethasone Intravitreal Implant, Ozurdex

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation	Baseline to 18 Months	Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation

Countries

Belgium, China, Germany, Greece, Israel, Italy, Portugal, Taiwan, United Kingdom

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results