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NCT05978622Completed

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)

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
236 (actual)
First submitted
31 Jul 2023
Start date
30 Oct 2023
Primary completion date
13 Aug 2026
Lead sponsor
AbbVie
NCT number
NCT05978622

What you commit to

  • Study type: Observational
  • Participants enrolled: 236
  • From 30 Oct 2023 to the primary completion date, 13 Aug 2026
  • 54 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any concomitant ocular or neurologic condition in the study eye that could cause macular edema or affect vision (except cataract)
  • History of Pan-Retinal Photocoagulation (PRP) or sectorial photocoagulation in the study eye in the 3 months prior to Baseline
  • Prior use of intravitreal corticosteroids in the study eye

Other illness

  • History of ocular surgery within 60 days of Baseline in the study eye
  • Uncontrolled Ocular Hypertension (OHT) or advanced glaucoma in the study 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

Other

  • Significant media opacities in the study eye limiting Optical Coherence Tomography (OCT) quality
  • Active ocular inflammation in either eye
  • Patients with contraindications to DEX-I

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (54)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Saint Pierre /ID# 257650
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BrusselsBelgiumUnknown status
Uza /Id# 255831
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EdegemBelgiumUnknown status
Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 255934
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GenkBelgiumUnknown status
Universitair Ziekenhuis Brussel /ID# 255324
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JetteBelgiumUnknown status
CHR de la Citadelle /ID# 257254
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LiègeBelgiumUnknown status
Vitaz /Id# 265553
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Sint-NiklaasBelgiumUnknown status
West China Hospital, Sichuan University /ID# 262745
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ChengduChinaUnknown status
Qingdao Eye Hospital Of Shandong First Medical University /ID# 262756
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QingdaoChinaUnknown status
Shenzhen Eye Hospital /ID# 262954
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ShenzhenChinaUnknown status
Tongji Hospital /ID# 270275
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WuhanChinaUnknown status
Xi'an Fourth Hospital /ID# 262972
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Xi'anChinaUnknown status
Augenzentrum Prinz 25 /ID# 261090
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AugsburgGermanyUnknown status
MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798
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BonnGermanyUnknown status
Dres. Schubert/Wissmann /ID# 261598
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EttlingenGermanyUnknown status
Augenzentrum Frankfurt /ID# 255576
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Frankfurt am MainGermanyUnknown status
Augenzentrum Frohe Zukunft /ID# 256290
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HalleGermanyUnknown status
Universitaetsklinikum Leipzig /ID# 255660
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LeipzigGermanyUnknown status
Augenzentrum Am Johannisplatz /ID# 255754
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LeipzigGermanyUnknown status
MVZ Augenzentrum am Berliner Ring /ID# 267412
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WürzburgGermanyUnknown status
Royal Victoria Hospital /Id# 260232
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BelfastUnited KingdomUnknown status
Bradford Teaching hospitals/ Bradford macular centre /ID# 260909
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BradfordUnited KingdomUnknown status
Gloucestershire Hospitals NHS Foundation Trust /ID# 256886
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CheltenhamUnited KingdomUnknown status
Liverpool University Hospitals NHS Foundation Trust /ID# 260230
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LiverpoolUnited KingdomUnknown status
Moorfields Eye Hospital /ID# 258465
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LondonUnited KingdomUnknown status
East Cheshire NHS Trust /ID# 270263
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MacclesfieldUnited KingdomUnknown status
University Hospitals Plymouth NHS Trust /ID# 260908
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PlymouthUnited KingdomUnknown status
Sunderland Eye Infirmary /ID# 258466
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SunderlandUnited KingdomUnknown status
Great Western Hospital /ID# 258467
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SwindonUnited KingdomUnknown status
University General Hospital of Alexandroupoli /ID# 275850
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AlexandroupoliGreeceUnknown status
Eye Clinic of Athens /ID# 258749
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AthensGreeceUnknown status
University General Hospital Attikon /ID# 257957
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ChaïdáriGreeceUnknown status
University General Hospital of Heraklion PA.G.N.I /ID# 258313
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HeraklionGreeceUnknown status
General Hospital of Lamia /ID# 265442
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LamiaGreeceUnknown status
Reg Gen Univ Hosp Larissa /ID# 255235
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LarissaGreeceUnknown status
Papageorgiou General Hospital /ID# 265500
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ThessalonikiGreeceUnknown status
Opthalmica SA /ID# 258748
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ThessalonikiGreeceUnknown status
Rabin Medical Center /ID# 265476
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Petah TikvaIsraelUnknown status
Kaplan Medical Center /ID# 265471
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RehovotIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 265469
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Tel AvivIsraelUnknown status
Universita Politecnica delle Marche - AOU Ospedali Riuniti di Ancona /ID# 258072
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AnconaItalyUnknown status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 258134
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RomeItalyUnknown status
IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 258039
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RomeItalyUnknown status
Università di Torino /ID# 258442
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TorinoItalyUnknown status
ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 256293
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UdineItalyUnknown status
Hospital de Santa Maria Maior, EPE /ID# 261063
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BarcelosPortugalUnknown status
Unidade Local de Saude da Regiao de Leiria /ID# 262009
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LeiriaPortugalUnknown status
Centro Hospitalar do Baixo Vouga /ID# 264421
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PortoPortugalUnknown status
Unidade Local de Saude de Santo Antonio /ID# 262010
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PortoPortugalUnknown status
Unidade Local de Saude do Estuario do Tejo /ID# 267945
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Vila Franca de XiraPortugalUnknown status
Kaohsiung Veterans General Hospital /ID# 262429
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Kaohsiung CityTaiwanUnknown status
Far Eastern Memorial Hospital /ID# 262428
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New Taipei CityTaiwanUnknown status
China Medical University Hospital /ID# 262427
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TaichungTaiwanUnknown status
National Taiwan University Hospital /ID# 262426
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TaipeiTaiwanUnknown status
Linkou Chang Gung Memorial Hospital /ID# 256091
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Taoyuan CityTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.