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New hope for diabetic eye disease? Real-World study tests steroid implant

NCT ID NCT05978622

Knowledge-focused Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This observational study follows about 236 adults with diabetic macular edema (DME) who did not respond well to anti-VEGF injections and are now starting treatment with a dexamethasone implant (DEX-I). The implant slowly releases steroid medication into the eye. Researchers will track how many additional anti-VEGF injections patients need over 18 months in routine clinical practice. The goal is to understand real-world effectiveness of switching to DEX-I.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexamethasone intravitreal implant (DEX-I)
What this could lead to
If successful, this study could show that switching to a dexamethasone implant is a useful option for people with diabetic macular edema who don't respond well to standard anti-VEGF injections.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection and real-world variability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

236 people

The number who actually took part.

Started

Oct 2023

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema

Contacts and locations

Locations

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

    Udine, 33100, Italy

  • Augenzentrum Am Johannisplatz /ID# 255754

    Leipzig, 04103, Germany

  • Augenzentrum Frankfurt /ID# 255576

    Frankfurt am Main, 60549, Germany

  • Augenzentrum Frohe Zukunft /ID# 256290

    Halle, 06118, Germany

  • Augenzentrum Prinz 25 /ID# 261090

    Augsburg, 86150, Germany

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

    Bradford, BD5 0JD, United Kingdom

  • CHR de la Citadelle /ID# 257254

    Liège, 4000, Belgium

  • CHU Saint Pierre /ID# 257650

    Brussels, Brussels Capital, 1000, Belgium

  • Centro Hospitalar do Baixo Vouga /ID# 264421

    Porto, 3814-501, Portugal

  • China Medical University Hospital /ID# 262427

    Taichung, 40447, Taiwan

  • Dres. Schubert/Wissmann /ID# 261598

    Ettlingen, 76275, Germany

  • East Cheshire NHS Trust /ID# 270263

    Macclesfield, Cheshire, SK10 3BL, United Kingdom

  • Eye Clinic of Athens /ID# 258749

    Athens, 10672, Greece

  • Far Eastern Memorial Hospital /ID# 262428

    New Taipei City, 22060, Taiwan

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

    Rome, Roma, 00168, Italy

  • General Hospital of Lamia /ID# 265442

    Lamia, 35100, Greece

  • Gloucestershire Hospitals NHS Foundation Trust /ID# 256886

    Cheltenham, Gloucestershire, GL53 7AN, United Kingdom

  • Great Western Hospital /ID# 258467

    Swindon, SN3 6BB, United Kingdom

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

    Barcelos, Braga District, 4750-275, Portugal

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

    Rome, Roma, 00184, Italy

  • Kaohsiung Veterans General Hospital /ID# 262429

    Kaohsiung City, 813, Taiwan

  • Kaplan Medical Center /ID# 265471

    Rehovot, Central District, 7660101, Israel

  • Linkou Chang Gung Memorial Hospital /ID# 256091

    Taoyuan City, 333, Taiwan

  • Liverpool University Hospitals NHS Foundation Trust /ID# 260230

    Liverpool, Merseyside, L9 7AL, United Kingdom

  • MVZ Augenzentrum am Berliner Ring /ID# 267412

    Würzburg, Bavaria, 97080, Germany

  • MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798

    Bonn, North Rhine-Westphalia, 53177, Germany

  • Moorfields Eye Hospital /ID# 258465

    London, Greater London, EC1V 2PD, United Kingdom

  • National Taiwan University Hospital /ID# 262426

    Taipei, 100, Taiwan

  • Opthalmica SA /ID# 258748

    Thessaloniki, 54643, Greece

  • Papageorgiou General Hospital /ID# 265500

    Thessaloniki, 56429, Greece

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

    Qingdao, Shandong, 266071, China

  • Rabin Medical Center /ID# 265476

    Petah Tikva, Central District, 4941492, Israel

  • Reg Gen Univ Hosp Larissa /ID# 255235

    Larissa, 41110, Greece

  • Royal Victoria Hospital /Id# 260232

    Belfast, BT12 6BA, United Kingdom

  • Shenzhen Eye Hospital /ID# 262954

    Shenzhen, Guangdong, 518034, China

  • Sunderland Eye Infirmary /ID# 258466

    Sunderland, SR2 9HP, United Kingdom

  • Tel Aviv Sourasky Medical Center /ID# 265469

    Tel Aviv, Tel Aviv, 6423906, Israel

  • Tongji Hospital /ID# 270275

    Wuhan, Hubei, 430030, China

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

    Leiria, 2410-197, Portugal

  • Unidade Local de Saude de Santo Antonio /ID# 262010

    Porto, 4099-003, Portugal

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

    Vila Franca de Xira, Lisbon District, 2600-009, Portugal

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

    Ancona, 60126, Italy

  • Universitaetsklinikum Leipzig /ID# 255660

    Leipzig, Saxony, 04103, Germany

  • Universitair Ziekenhuis Brussel /ID# 255324

    Jette, Brussels Capital, 1090, Belgium

  • University General Hospital Attikon /ID# 257957

    Chaïdári, Attica, 12462, Greece

  • University General Hospital of Alexandroupoli /ID# 275850

    Alexandroupoli, Evros, 68100, Greece

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

    Heraklion, Crete, 71500, Greece

  • University Hospitals Plymouth NHS Trust /ID# 260908

    Plymouth, Devon, PL6 8DH, United Kingdom

  • Università di Torino /ID# 258442

    Torino, 10124, Italy

  • Uza /Id# 255831

    Edegem, Antwerpen, 2650, Belgium

  • Vitaz /Id# 265553

    Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

  • West China Hospital, Sichuan University /ID# 262745

    Chengdu, Sichuan, 610041, China

  • Xi'an Fourth Hospital /ID# 262972

    Xi'an, Shaanxi, 710004, China

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

    Genk, Limburg, 3600, Belgium

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