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

April 30, 2026 updated by: AbbVie

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • CHR de la Citadelle /ID# 257254
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Uza /Id# 255831
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1000
        • CHU Saint Pierre /ID# 257650
      • Jette, Brussels Capital, Belgium, 1090
        • Universitair Ziekenhuis Brussel /ID# 255324
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 255934
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
        • Vitaz /Id# 265553
  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518034
        • Shenzhen Eye Hospital /ID# 262954
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital /ID# 270275
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Xi'an Fourth Hospital /ID# 262972
    • Shandong
      • Qingdao, Shandong, China, 266071
        • Qingdao Eye Hospital Of Shandong First Medical University /ID# 262756
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University /ID# 262745
  • Germany
      • Augsburg, Germany, 86150
        • Augenzentrum Prinz 25 /ID# 261090
      • Ettlingen, Germany, 76275
        • Dres. Schubert/Wissmann /ID# 261598
      • Frankfurt am Main, Germany, 60549
        • Augenzentrum Frankfurt /ID# 255576
      • Halle, Germany, 06118
        • Augenzentrum Frohe Zukunft /ID# 256290
      • Leipzig, Germany, 04103
        • Augenzentrum Am Johannisplatz /ID# 255754
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • MVZ Augenzentrum am Berliner Ring /ID# 267412
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53177
        • MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Universitaetsklinikum Leipzig /ID# 255660
  • Greece
      • Athens, Greece, 10672
        • Eye Clinic of Athens /ID# 258749
      • Lamia, Greece, 35100
        • General Hospital of Lamia /ID# 265442
      • Larissa, Greece, 41110
        • Reg Gen Univ Hosp Larissa /ID# 255235
      • Thessaloniki, Greece, 54643
        • Opthalmica SA /ID# 258748
      • Thessaloniki, Greece, 56429
        • Papageorgiou General Hospital /ID# 265500
    • Attica
      • Athens, Attica, Greece, 12462
        • University General Hospital Attikon /ID# 257957
    • Crete
      • Heraklion, Crete, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 258313
    • Evros
      • Alexandroupoli, Evros, Greece, 68100
        • University General Hospital of Alexandroupoli /ID# 275850
  • Israel
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Rabin Medical Center /ID# 265476
      • Rehovot, Central District, Israel, 7660101
        • Kaplan Medical Center /ID# 265471
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 265469
  • Italy
      • Ancona, Italy, 60126
        • Universita Politecnica delle Marche - AOU Ospedali Riuniti di Ancona /ID# 258072
      • Torino, Italy, 10124
        • Università di Torino /ID# 258442
      • Udine, Italy, 33100
        • ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 256293
    • Roma
      • Rome, Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 258134
      • Rome, Roma, Italy, 00184
        • IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 258039
  • Portugal
      • Leiria, Portugal, 2410-197
        • Unidade Local de Saude da Regiao de Leiria, EPE /ID# 262009
      • Porto, Portugal, 3814-501
        • Centro Hospitalar do Baixo Vouga /ID# 264421
      • Porto, Portugal, 4099-003
        • Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 262010
      • Vila Franca de Xira, Portugal, 2600-009
        • Unidade Local de Saude do Estuario do Tejo, EPE /ID# 267945
    • Braga District
      • Barcelos, Braga District, Portugal, 4750-275
        • Hospital de Santa Maria Maior, EPE /ID# 261063
  • Taiwan
      • Kaohsiung City, Taiwan, 813
        • Kaohsiung Veterans General Hospital /ID# 262429
      • New Taipei City, Taiwan, 22060
        • Far Eastern Memorial Hospital /ID# 262428
      • Taichung, Taiwan, 40447
        • China Medical University Hospital /ID# 262427
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital /ID# 256091
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • National Taiwan University Hospital /ID# 262426
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Royal Victoria Hospital /Id# 260232
      • Bradford, United Kingdom, BD5 0JD
        • Bradford Teaching hospitals/ Bradford macular centre /ID# 260909
      • Sunderland, United Kingdom, SR2 9HP
        • Sunderland Eye Infirmary /ID# 258466
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital /ID# 258467
    • Cheshire
      • Macclesfield, Cheshire, United Kingdom, SK10 3BL
        • East Cheshire NHS Trust /ID# 270263
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Derriford Hospital and the Royal Eye Infirmary /ID# 260908
    • Gloucestershire
      • Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
        • Gloucestershire Hospitals NHS Foundation Trust /ID# 256886
    • Greater London
      • London, Greater London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital /ID# 258465
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L9 7AL
        • Liverpool University Hospitals NHS Foundation Trust /ID# 260230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants with diabetic macular edema and sub-optimal response to anti-VEGF therapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P23-380

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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