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

Sponsor

AbbVie (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05978622

Collaborator

(none)

327

Enrollment

30.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema

Study Design

Study Type:

Observational

Anticipated Enrollment :

327 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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)

Anticipated Study Start Date :

Sep 12, 2023

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Dexamethasone Intravitreal Implant (DEX-I) Dexamethasone 700 μg intravitreal implant (DEX-I) administered according to general clinical practice.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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