Clinical trial NCT05978622: Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema
DME
Dexamethasone
Dexamethasone Intravitreal Implant
Ozurdex
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with diabetic macular edema and sub-optimal response to anti-VEGF therapy.

Brief 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 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

Primary outcomes:
measure: Number of Additional Anti-VEGF Injections after Baseline and before DEX-I Initiation
timeFrame: Baseline to 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Uza /Id# 255831
state: Antwerpen
city: Bruxelles
country: Belgium
facility: CHU Saint Pierre /ID# 257650
state: Bruxelles-Capitale
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel /ID# 255324
state: Bruxelles-Capitale
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg /ID# 255934
state: Limburg
city: Sint-Niklaas
country: Belgium
facility: Vitaz /Id# 265553
state: Oost-Vlaanderen
city: Liege
country: Belgium
facility: CHR de la Citadelle /ID# 257254
city: Shenzhen
country: China
facility: Shenzhen Eye Hospital /ID# 262954
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital /ID# 270275
state: Hubei
city: Xian
country: China
facility: Xi'an Fourth Hospital /ID# 262972
state: Shaanxi
city: Qingdao
country: China
facility: Qingdao Eye Hospital Of Shandong First Medical University /ID# 262756
state: Shandong
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 262745
state: Sichuan
city: Würzburg
country: Germany
facility: MVZ Augenzentrum am Berliner Ring /ID# 267412
state: Bayern
city: Bonn
country: Germany
facility: MVZ der Klinik Dardenne GmbH Makulazentrum /ID# 269798
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig /ID# 255660
state: Sachsen
city: Augsburg
country: Germany
facility: Augenzentrum Prinz 25 /ID# 261090
city: Ettlingen
country: Germany
facility: Dres. Schubert/Wissmann /ID# 261598
city: Frankfurt am Main
country: Germany
facility: Augenzentrum Frankfurt /ID# 255576
city: Halle (Saale)
country: Germany
facility: Augenzentrum Frohe Zukunft /ID# 256290
city: Leipzig
country: Germany
facility: Augenzentrum am Johannisplatz /ID# 255754
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 257957
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 258313
state: Kriti
city: Athens
country: Greece
facility: Eye Clinic of Athens /ID# 258749
city: Lamia
country: Greece
facility: General Hospital of Lamia /ID# 265442
city: Larisa
country: Greece
facility: Reg Gen Univ Hosp Larissa /ID# 255235
city: Thessaloniki
country: Greece
facility: Opthalmica SA /ID# 258748
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital /ID# 265500
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 265476
state: HaMerkaz
city: Rekhovot
country: Israel
facility: Kaplan Medical Center /ID# 265471
state: HaMerkaz
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 258134
state: Roma
city: Rome
country: Italy
facility: IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 258039
state: Roma
city: Ancona
country: Italy
facility: Universita Politecnica delle Marche - AOU Ospedali Riuniti di Ancona /ID# 258072
city: Torino
country: Italy
facility: Università di Torino /ID# 258442
city: Udine
country: Italy
facility: ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 256293
city: Barcelos
country: Portugal
facility: Hospital de Santa Maria Maior, EPE /ID# 261063
state: Braga
city: Leiria
country: Portugal
facility: Unidade Local de Saude da Regiao de Leiria, EPE /ID# 262009
city: Porto
country: Portugal
facility: Centro Hospitalar do Baixo Vouga /ID# 264421
city: Porto
country: Portugal
facility: Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 262010
city: Vila Franca de Xira
country: Portugal
facility: Unidade Local de Saude do Estuario do Tejo, EPE /ID# 267945
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 262426
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital /ID# 262429
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital /ID# 262428
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 262427
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 256091
city: Plymouth
country: United Kingdom
facility: Derriford Hospital and the Royal Eye Infirmary /ID# 260908
state: Devon
city: Cheltenham
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust /ID# 256886
state: Gloucestershire
city: London
country: United Kingdom
facility: Moorfields Eye Hospital /ID# 258465
state: Greater London
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital /Id# 260232
city: Bradford
country: United Kingdom
facility: Bradford Teaching hospitals/ Bradford macular centre /ID# 260909
city: Liverpool
country: United Kingdom
facility: Liverpool Univeristy Hospitals NHS Foundation Trust /ID# 260230
city: Macclesfield
country: United Kingdom
facility: East Cheshire NHS Trust /ID# 270263
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infirmary /ID# 258466
city: Swindon
country: United Kingdom
facility: Great Western Hospital /ID# 258467
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: