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: February 11, 2026
Sponsor: AbbVie
Overall Status: Active - Not 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: 236
Study Start date:
October 30, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Uza /Id# 255831

    Edegem, Antwerpen 2650
    Belgium

    Site Not Available

  • Uza /Id# 255831

    Edegem 2799007, Antwerpen 2650
    Belgium

    Site Not Available

  • CHU Saint Pierre /ID# 257650

    Brussels 2800866, Brussels Capital 2800867 1000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel /ID# 255324

    Jette 2794914, Brussels Capital 2800867 1090
    Belgium

    Site Not Available

  • CHU Saint Pierre /ID# 257650

    Bruxelles, Bruxelles-Capitale 1000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel /ID# 255324

    Jette, Bruxelles-Capitale 1090
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg /ID# 255934

    Genk, Limburg 3600
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 255934

    Genk 2797670, Limburg 3600
    Belgium

    Site Not Available

  • CHR de la Citadelle /ID# 257254

    Liege, Limburg 4000
    Belgium

    Site Not Available

  • Vitaz /Id# 265553

    Sint-Niklaas, Oost-Vlaanderen 9100
    Belgium

    Site Not Available

  • Vitaz /Id# 265553

    Sint-Niklaas 2786578, Oost-Vlaanderen 9100
    Belgium

    Site Not Available

  • UZ Brussel /ID# 255324

    Brussels, 1090
    Belgium

    Site Not Available

  • CHR de la Citadelle /ID# 257254

    Liège 2792413, 4000
    Belgium

    Site Not Available

  • Shenzhen Eye Hospital /ID# 262954

    Shenzhen, Guangdong 518034
    China

    Site Not Available

  • Shenzhen Eye Hospital /ID# 262954

    Shenzhen 1795565, Guangdong 1809935 518034
    China

    Site Not Available

  • Tongji Hospital /ID# 270275

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Tongji Hospital /ID# 270275

    Wuhan 1791247, Hubei 1806949 430030
    China

    Site Not Available

  • Xi'an Fourth Hospital /ID# 262972

    Xian, Shaanxi 710004
    China

    Site Not Available

  • Xi'an Fourth Hospital /ID# 262972

    Xi'an 1790630, Shaanxi 1796480 710004
    China

    Site Not Available

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

    Qingdao, Shandong 266071
    China

    Site Not Available

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

    Qingdao, Shandong 266023
    China

    Active - Recruiting

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

    Qingdao 1797929, Shandong 1796328 266071
    China

    Site Not Available

  • West China Hospital, Sichuan University /ID# 262745

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University /ID# 262745

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Site Not Available

  • MVZ Augenzentrum am Berliner Ring /ID# 267412

    Würzburg 2805615, Bavaria 2951839 97080
    Germany

    Site Not Available

  • MVZ Augenzentrum am Berliner Ring /ID# 267412

    Würzburg, Bayern 97080
    Germany

    Site Not Available

  • MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798

    Bonn, Nordrhein-Westfalen 53177
    Germany

    Site Not Available

  • MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798

    Bonn 2946447, North Rhine-Westphalia 2861876 53177
    Germany

    Site Not Available

  • Universitaetsklinikum Leipzig /ID# 255660

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig /ID# 255660

    Leipzig 2879139, Saxony 2842566 04103
    Germany

    Site Not Available

  • Augenzentrum Prinz 25 /ID# 261090

    Augsburg, 86150
    Germany

    Site Not Available

  • Augenzentrum Prinz 25 /ID# 261090

    Augsburg 2954172, 86150
    Germany

    Site Not Available

  • Dres. Schubert/Wissmann /ID# 261598

    Ettlingen, 76275
    Germany

    Site Not Available

  • Dres. Schubert/Wissmann /ID# 261598

    Ettlingen 2928615, 76275
    Germany

    Site Not Available

  • Augenzentrum Frankfurt /ID# 255576

    Frankfurt am Main, 60549
    Germany

    Site Not Available

  • Augenzentrum Frankfurt /ID# 255576

    Frankfurt am Main 2925533, 60549
    Germany

    Site Not Available

  • Augenzentrum Frohe Zukunft /ID# 256290

    Halle 2911522, 06118
    Germany

    Site Not Available

  • Augenzentrum Frohe Zukunft /ID# 256290

    Halle (Saale), 06118
    Germany

    Site Not Available

  • Augenzentrum am Johannisplatz /ID# 255754

    Leipzig, 04103
    Germany

    Site Not Available

  • Augenzentrum Am Johannisplatz /ID# 255754

    Leipzig 2879139, 04103
    Germany

    Site Not Available

  • University General Hospital Attikon /ID# 257957

    Athens 264371, Attica 6692632 12462
    Greece

    Site Not Available

  • University General Hospital Attikon /ID# 257957

    Athens, Attiki 12462
    Greece

    Site Not Available

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

    Heraklion 261745, Crete 6697802 71500
    Greece

    Site Not Available

  • University General Hospital of Alexandroupoli /ID# 275850

    Alexandroupoli, Evros 68100
    Greece

    Site Not Available

  • University General Hospital of Alexandroupoli /ID# 275850

    Alexandroupoli 736928, Evros 68100
    Greece

    Site Not Available

  • Papageorgiou General Hospital /ID# 265500

    Thessaloniki, Evrytania 56429
    Greece

    Site Not Available

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

    Heraklion, Kriti 71500
    Greece

    Site Not Available

  • Eye Clinic of Athens /ID# 258749

    Athens, 10672
    Greece

    Active - Recruiting

  • Eye Clinic of Athens /ID# 258749

    Athens 264371, 10672
    Greece

    Site Not Available

  • General Hospital of Lamia /ID# 265442

    Lamia, 35100
    Greece

    Site Not Available

  • General Hospital of Lamia /ID# 265442

    Lamia 258620, 35100
    Greece

    Site Not Available

  • Reg Gen Univ Hosp Larissa /ID# 255235

    Larisa, 41110
    Greece

    Site Not Available

  • Reg Gen Univ Hosp Larissa /ID# 255235

    Larissa 258576, 41110
    Greece

    Site Not Available

  • Opthalmica SA /ID# 258748

    Thessaloniki, 54643
    Greece

    Active - Recruiting

  • Opthalmica SA /ID# 258748

    Thessaloniki 734077, 54643
    Greece

    Site Not Available

  • Papageorgiou General Hospital /ID# 265500

    Thessaloniki 734077, 56429
    Greece

    Site Not Available

  • Rabin Medical Center /ID# 265476

    Petah Tikva 293918, Central District 294904 4941492
    Israel

    Site Not Available

  • Kaplan Medical Center /ID# 265471

    Rehovot 293725, Central District 294904 7660101
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 265476

    Petah Tikva, HaMerkaz 4941492
    Israel

    Site Not Available

  • Kaplan Medical Center /ID# 265471

    Rekhovot, HaMerkaz 7660101
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 265469

    Tel Aviv 293397, Tel Aviv 293396 6423906
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 265469

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Site Not Available

  • 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

    Site Not Available

  • 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

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

    Rome 3169070, Roma 00168
    Italy

    Site Not Available

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

    Rome 3169070, Roma 00184
    Italy

    Site Not Available

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

    Ancona, 60126
    Italy

    Site Not Available

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

    Ancona 3183089, 60126
    Italy

    Site Not Available

  • Università di Torino /ID# 258442

    Torino, 10124
    Italy

    Site Not Available

  • Università di Torino /ID# 258442

    Torino 8980539, 10124
    Italy

    Site Not Available

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

    Udine, 33100
    Italy

    Site Not Available

  • 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

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

    Udine 3165072, 33100
    Italy

    Site Not Available

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

    Barcelos, Braga 4750-275
    Portugal

    Site Not Available

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

    Barcelos 2742416, Braga District 2742031 4750-275
    Portugal

    Site Not Available

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

    Leiria, 2410-197
    Portugal

    Site Not Available

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

    Leiria 2267095, 2410-197
    Portugal

    Site Not Available

  • Centro Hospitalar do Baixo Vouga /ID# 264421

    Porto, 3814-501
    Portugal

    Site Not Available

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

    Porto, 4099-003
    Portugal

    Active - Recruiting

  • Centro Hospitalar do Baixo Vouga /ID# 264421

    Porto 2735943, 3814-501
    Portugal

    Site Not Available

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

    Porto 2735943, 4099-003
    Portugal

    Site Not Available

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

    Vila Franca de Xira, 2600-009
    Portugal

    Site Not Available

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

    Vila Franca de Xira 2261639, 2600-009
    Portugal

    Site Not Available

  • National Taiwan University Hospital /ID# 262426

    Taipei City, Taipei 7280290 100
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital /ID# 262429

    Kaohsiung, 81362
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital /ID# 262429

    Kaohsiung City, 813
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital /ID# 262429

    Kaohsiung City 1673820, 813
    Taiwan

    Site Not Available

  • Far Eastern Memorial Hospital /ID# 262428

    New Taipei City, 22060
    Taiwan

    Site Not Available

  • Far Eastern Memorial Hospital /ID# 262428

    New Taipei City 12908892, 22060
    Taiwan

    Site Not Available

  • China Medical University Hospital /ID# 262427

    Taichung, 40447
    Taiwan

    Site Not Available

  • China Medical University Hospital /ID# 262427

    Taichung 1668399, 40447
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital /ID# 256091

    Taoyuan 6696918, 333
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital /ID# 256091

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Sunderland Eye Infirmary /ID# 258466

    Sunderland, Bolton SR2 9HP
    United Kingdom

    Site Not Available

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

    Plymouth, Devon PL6 8DH
    United Kingdom

    Site Not Available

  • University Hospital Plymouth NHS Trust /ID# 260908

    Plymouth, Devon PL6 5FP
    United Kingdom

    Active - Recruiting

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

    Plymouth 2640194, Devon PL6 8DH
    United Kingdom

    Site Not Available

  • Gloucestershire Hospitals NHS Foundation Trust /ID# 256886

    Cheltenham, Gloucestershire GL53 7AN
    United Kingdom

    Site Not Available

  • Gloucestershire Hospitals NHS Foundation Trust /ID# 256886

    Cheltenham 2653261, Gloucestershire GL53 7AN
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital /ID# 258465

    London, Greater London EC1V 2PD
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital /ID# 258465

    London 2643743, Greater London EC1V 2PD
    United Kingdom

    Site Not Available

  • Liverpool University Hospitals NHS Foundation Trust /ID# 260230

    Liverpool 2644210, Merseyside L9 7AL
    United Kingdom

    Site Not Available

  • Royal Victoria Hospital /Id# 260232

    Belfast, BT12 6BA
    United Kingdom

    Site Not Available

  • Royal Victoria Hospital /Id# 260232

    Belfast 2655984, BT12 6BA
    United Kingdom

    Site Not Available

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

    Bradford, BD5 0JD
    United Kingdom

    Site Not Available

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

    Bradford 2654993, BD5 0JD
    United Kingdom

    Site Not Available

  • Liverpool Univeristy Hospitals NHS Foundation Trust /ID# 260230

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • 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

    Site Not Available

  • East Cheshire NHS Trust /ID# 270263

    Macclesfield 2643266, SK10 3BL
    United Kingdom

    Site Not Available

  • University Hospitals Plymouth NHS Trust /ID# 260908

    Plymouth, PL6 8DH
    United Kingdom

    Active - Recruiting

  • Sunderland Eye Infirmary /ID# 258466

    Sunderland 2636531, SR2 9HP
    United Kingdom

    Site Not Available

  • Great Western Hospital /ID# 258467

    Swindon, SN3 6BB
    United Kingdom

    Site Not Available

  • Great Western Hospital /ID# 258467

    Swindon 2636389, SN3 6BB
    United Kingdom

    Site Not Available

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