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

Last updated: March 25, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Macular Edema

Macular Edema

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT05978622
P23-380
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 12months prior to DEX-I initiation

  • Study eye newly prescribed DEX-I. The prescribing decision lies with the physicianand reflects their standard practice

  • Participant showing a suboptimal response to anti-VEGF at Baseline in the study eye

Exclusion

Exclusion Criteria:

  • Any concomitant ocular or neurologic condition in the study eye that could causemacular 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 thestudy 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 ChamberIntraocular Lens (ACIOL), iris or scleral-fixed Intraocular Lens (IOL) or history ofcomplicated cataract surgery with PCR

  • Prior use of intravitreal corticosteroids in the study eye

  • Patients with contraindications to DEX-I

Study Design

Total Participants: 327
Study Start date:
October 30, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Uza /Id# 255831

    Edegem, Antwerpen 2650
    Belgium

    Active - Recruiting

  • CHU Saint Pierre /ID# 257650

    Bruxelles, Bruxelles-Capitale 1000
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Brussel /ID# 255324

    Jette, Bruxelles-Capitale 1090
    Belgium

    Active - Recruiting

  • Ziekenhuis Oost-Limburg /ID# 255934

    Genk, Limburg 3600
    Belgium

    Active - Recruiting

  • Vitaz /Id# 265553

    Sint-Niklaas, Oost-Vlaanderen 9100
    Belgium

    Active - Recruiting

  • UZ Brussel /ID# 255324

    Brussels, 1090
    Belgium

    Site Not Available

  • CHR de la Citadelle /ID# 257254

    Liege, 4000
    Belgium

    Completed

  • Shenzhen Eye Hospital /ID# 262954

    Shenzhen, Guangdong 518034
    China

    Active - Recruiting

  • Tongji Hospital /ID# 270275

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Xi'an Fourth Hospital /ID# 262972

    Xian, Shaanxi 710004
    China

    Active - Recruiting

  • Qingdao Eye Hospital Of Shandong First Medical University /ID# 262756

    Qingdao, Shandong 266071
    China

    Active - Recruiting

  • Qingdao Eye Hospital of Shandong First Medical University /ID# 262756

    Qingdao, Shandong 266023
    China

    Active - Recruiting

  • West China Hospital, Sichuan University /ID# 262745

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • MVZ Augenzentrum am Berliner Ring /ID# 267412

    Würzburg, Bayern 97080
    Germany

    Active - Recruiting

  • MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798

    Bonn, Nordrhein-Westfalen 53177
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig /ID# 255660

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Augenzentrum Prinz 25 /ID# 261090

    Augsburg, 86150
    Germany

    Active - Recruiting

  • Dres. Schubert/Wissmann /ID# 261598

    Ettlingen, 76275
    Germany

    Active - Recruiting

  • Augenzentrum Frankfurt /ID# 255576

    Frankfurt am Main, 60549
    Germany

    Active - Recruiting

  • Augenzentrum Frohe Zukunft /ID# 256290

    Halle (Saale), 06118
    Germany

    Active - Recruiting

  • Augenzentrum am Johannisplatz /ID# 255754

    Leipzig, 04103
    Germany

    Active - Recruiting

  • University General Hospital Attikon /ID# 257957

    Athens, Attiki 12462
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion PA.G.N.I /ID# 258313

    Heraklion, Kriti 71500
    Greece

    Active - Recruiting

  • Eye Clinic of Athens /ID# 258749

    Athens, 10672
    Greece

    Active - Recruiting

  • General Hospital of Lamia /ID# 265442

    Lamia, 35100
    Greece

    Active - Recruiting

  • Reg Gen Univ Hosp Larissa /ID# 255235

    Larisa, 41110
    Greece

    Active - Recruiting

  • Opthalmica SA /ID# 258748

    Thessaloniki, 54643
    Greece

    Active - Recruiting

  • Papageorgiou General Hospital /ID# 265500

    Thessaloniki, 56429
    Greece

    Active - Recruiting

  • Rabin Medical Center /ID# 265476

    Petah Tikva, HaMerkaz 4941492
    Israel

    Active - Recruiting

  • Kaplan Medical Center /ID# 265471

    Rekhovot, HaMerkaz 7660101
    Israel

    Active - Recruiting

  • Fondazione Policlinico A. Gemelli /ID# 258134

    Rome, Roma 00168
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 258134

    Rome, Roma 00168
    Italy

    Active - Recruiting

  • IRCCS Fondazione Bietti /ID# 258039

    Rome, Roma 00184
    Italy

    Active - Recruiting

  • IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 258039

    Rome, Roma 00184
    Italy

    Active - Recruiting

  • Universita Politecnica delle Marche - AOU Ospedali Riuniti di Ancona /ID# 258072

    Ancona, 60126
    Italy

    Active - Recruiting

  • Università di Torino /ID# 258442

    Torino, 10124
    Italy

    Active - Recruiting

  • ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 256293

    Udine, 33100
    Italy

    Active - Recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) /ID# 256293

    Udine, 33100
    Italy

    Active - Recruiting

  • University Hospital Santa Maria della Misericordia /ID# 256293

    Udine, 33100
    Italy

    Active - Recruiting

  • Hospital de Santa Maria Maior, EPE /ID# 261063

    Barcelos, Braga 4750-275
    Portugal

    Active - Recruiting

  • Unidade Local de Saude da Regiao de Leiria, EPE /ID# 262009

    Leiria, 2410-197
    Portugal

    Active - Recruiting

  • Centro Hospitalar do Baixo Vouga /ID# 264421

    Porto, 3814-501
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 262010

    Porto, 4099-003
    Portugal

    Active - Recruiting

  • Unidade Local de Saude do Estuario do Tejo, EPE /ID# 267945

    Vila Franca de Xira, 2600-009
    Portugal

    Active - Recruiting

  • National Taiwan University Hospital /ID# 262426

    Taipei City, Taipei 100
    Taiwan

    Active - Recruiting

  • Kaohsiung Veterans General Hospital /ID# 262429

    Kaohsiung, 81362
    Taiwan

    Active - Recruiting

  • Far Eastern Memorial Hospital /ID# 262428

    New Taipei City, 22060
    Taiwan

    Active - Recruiting

  • China Medical University Hospital /ID# 262427

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 256091

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

  • Derriford Hospital and the Royal Eye Infirmary /ID# 260908

    Plymouth, Devon PL6 8DH
    United Kingdom

    Active - Recruiting

  • University Hospital Plymouth NHS Trust /ID# 260908

    Plymouth, Devon PL6 5FP
    United Kingdom

    Active - Recruiting

  • Gloucestershire Hospitals NHS Foundation Trust /ID# 256886

    Cheltenham, Gloucestershire GL53 7AN
    United Kingdom

    Active - Recruiting

  • Moorfields Eye Hospital /ID# 258465

    London, Greater London EC1V 2PD
    United Kingdom

    Active - Recruiting

  • Royal Victoria Hospital /Id# 260232

    Belfast, BT12 6BA
    United Kingdom

    Completed

  • Bradford Teaching hospitals/ Bradford macular centre /ID# 260909

    Bradford, BD5 0JD
    United Kingdom

    Completed

  • Liverpool Univeristy Hospitals NHS Foundation Trust /ID# 260230

    Liverpool, L9 7AL
    United Kingdom

    Active - Recruiting

  • Moorfields Eye Hospital NHS Foundation Trust /ID# 258465

    London, EC1V 2PD
    United Kingdom

    Active - Recruiting

  • East Cheshire NHS Trust /ID# 270263

    Macclesfield, SK10 3BL
    United Kingdom

    Active - Recruiting

  • University Hospitals Plymouth NHS Trust /ID# 260908

    Plymouth, PL6 8DH
    United Kingdom

    Active - Recruiting

  • Sunderland Eye Infirmary /ID# 258466

    Sunderland, SR2 9HP
    United Kingdom

    Active - Recruiting

  • Great Western Hospital /ID# 258467

    Swindon, SN3 6BB
    United Kingdom

    Active - Recruiting

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