Diabetic Macular EdemaP23-380 - INITNCT05978622
Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant
An observational study of Diabetic Macular Edema, run by AbbVie at 54 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- How many people
- 236 participants
- Where
- 54 sitesin 9 countries
- Study dates
- 30 Oct 2023to 13 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with diabetic macular edema and sub-optimal response to anti-VEGF therapy.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
54 sites in 9 countries.
54 sites in 9 countries
United Kingdom9 sites
Royal Victoria Hospital /Id# 260232
Belfast, BT12 6BA
Bradford Teaching hospitals/ Bradford macular centre /ID# 260909
Bradford, BD5 0JD
Gloucestershire Hospitals NHS Foundation Trust /ID# 256886
Cheltenham, Gloucestershire, GL53 7AN
Liverpool University Hospitals NHS Foundation Trust /ID# 260230
Liverpool, Merseyside, L9 7AL
Moorfields Eye Hospital /ID# 258465
London, Greater London, EC1V 2PD
East Cheshire NHS Trust /ID# 270263
Macclesfield, Cheshire, SK10 3BL
University Hospitals Plymouth NHS Trust /ID# 260908
Plymouth, Devon, PL6 8DH
Sunderland Eye Infirmary /ID# 258466
Sunderland, SR2 9HP
Great Western Hospital /ID# 258467
Swindon, SN3 6BB
Germany8 sites
Augenzentrum Prinz 25 /ID# 261090
Augsburg, 86150
MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798
Bonn, North Rhine-Westphalia, 53177
Dres. Schubert/Wissmann /ID# 261598
Ettlingen, 76275
Augenzentrum Frankfurt /ID# 255576
Frankfurt am Main, 60549
Augenzentrum Frohe Zukunft /ID# 256290
Halle, 06118
Universitaetsklinikum Leipzig /ID# 255660
Leipzig, Saxony, 04103
Augenzentrum Am Johannisplatz /ID# 255754
Leipzig, 04103
MVZ Augenzentrum am Berliner Ring /ID# 267412
Würzburg, Bavaria, 97080
Greece8 sites
University General Hospital of Alexandroupoli /ID# 275850
Alexandroupoli, Evros, 68100
Eye Clinic of Athens /ID# 258749
Athens, 10672
University General Hospital Attikon /ID# 257957
Chaïdári, Attica, 12462
University General Hospital of Heraklion PA.G.N.I /ID# 258313
Heraklion, Crete, 71500
General Hospital of Lamia /ID# 265442
Lamia, 35100
Reg Gen Univ Hosp Larissa /ID# 255235
Larissa, 41110
Opthalmica SA /ID# 258748
Thessaloniki, 54643
Papageorgiou General Hospital /ID# 265500
Thessaloniki, 56429
Belgium6 sites
CHU Saint Pierre /ID# 257650
Brussels, Brussels Capital, 1000
Uza /Id# 255831
Edegem, Antwerpen, 2650
Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 255934
Genk, Limburg, 3600
Universitair Ziekenhuis Brussel /ID# 255324
Jette, Brussels Capital, 1090
CHR de la Citadelle /ID# 257254
Liège, 4000
Vitaz /Id# 265553
Sint-Niklaas, Oost-Vlaanderen, 9100
China5 sites
West China Hospital, Sichuan University /ID# 262745
Chengdu, Sichuan, 610041
Qingdao Eye Hospital Of Shandong First Medical University /ID# 262756
Qingdao, Shandong, 266071
Shenzhen Eye Hospital /ID# 262954
Shenzhen, Guangdong, 518034
Tongji Hospital /ID# 270275
Wuhan, Hubei, 430030
Xi'an Fourth Hospital /ID# 262972
Xi'an, Shaanxi, 710004
Italy5 sites
Universita Politecnica delle Marche - AOU Ospedali Riuniti di Ancona /ID# 258072
Ancona, 60126
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 258134
Rome, Roma, 00168
IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 258039
Rome, Roma, 00184
Università di Torino /ID# 258442
Torino, 10124
ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 256293
Udine, 33100
Portugal5 sites
Hospital de Santa Maria Maior, EPE /ID# 261063
Barcelos, Braga District, 4750-275
Unidade Local de Saude da Regiao de Leiria /ID# 262009
Leiria, 2410-197
Centro Hospitalar do Baixo Vouga /ID# 264421
Porto, 3814-501
Unidade Local de Saude de Santo Antonio /ID# 262010
Porto, 4099-003
Unidade Local de Saude do Estuario do Tejo /ID# 267945
Vila Franca de Xira, Lisbon District, 2600-009
Taiwan5 sites
Kaohsiung Veterans General Hospital /ID# 262429
Kaohsiung City, 813
Far Eastern Memorial Hospital /ID# 262428
New Taipei City, 22060
China Medical University Hospital /ID# 262427
Taichung, 40447
National Taiwan University Hospital /ID# 262426
Taipei, 100
Linkou Chang Gung Memorial Hospital /ID# 256091
Taoyuan City, 333
Israel3 sites
Rabin Medical Center /ID# 265476
Petah Tikva, Central District, 4941492
Kaplan Medical Center /ID# 265471
Rehovot, Central District, 7660101
Tel Aviv Sourasky Medical Center /ID# 265469
Tel Aviv, Tel Aviv, 6423906
About this study
Official title: 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.
Read more
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.
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, DME, Dexamethasone, Dexamethasone Intravitreal Implant, Ozurdex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Intravitreal Implant (DEX-I) | Dexamethasone 700 μg intravitreal implant (DEX-I) administered according to general clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation
Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation
Measured: Baseline to 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start30 Oct 2023
- Primary completion13 Aug 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978622
- Sponsor's protocol ID
- P23-380
- Acronym
- P23-380 - INIT
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05978622
- Acronym / sponsor ID
- P23-380 - INIT / P23-380
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, DME, Dexamethasone, Dexamethasone Intravitreal Implant, Ozurdex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 13 Aug 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Intravitreal Implant (DEX-I) | – | –Dexamethasone 700 μg intravitreal implant (DEX-I) administered according to general clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with diabetic macular edema and sub-optimal response to anti-VEGF therapy.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
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RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
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COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
54 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by AbbVie at 54 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United Kingdom, Germany, Greece, Belgium, China and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation (time frame: Baseline to 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.