A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME). (4SIGHT)
4. november 2026 opdateret af: 4D Molecular Therapeutics
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Efficacy, Safety, and Durability of a Single Intravitreal Injection of 4D-150 Versus Aflibercept in Adults With Diabetic Macular Edema (4SIGHT)
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Safety, Efficacy, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
514
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: 4DMT Patient Advocacy
- Telefonnummer: (888) 748-8881
- E-mail: clinicaltrials@4DMT.com
Undersøgelse Kontakt Backup
- Navn: 4SIGHT Medical Monitoring Distribution List
- E-mail: 4D150C005_MM@4dmt.com
Studiesteder
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85255
- Rekruttering
- Research Network Arizona
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California
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Encino, California, Forenede Stater, 91436
- Rekruttering
- The Retina Partners
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Fullerton, California, Forenede Stater, 92835
- Ikke rekrutterer endnu
- Retina Consultants of Orange County
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Huntington Beach, California, Forenede Stater, 90266
- Ikke rekrutterer endnu
- Retina Associates of Southern California
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Sacramento, California, Forenede Stater, 95825
- Ikke rekrutterer endnu
- Retinal Consultants Medical Group Inc.
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San Diego, California, Forenede Stater, 92064
- Ikke rekrutterer endnu
- Retina Consultants San Diego
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San Mateo, California, Forenede Stater, 94401
- Ikke rekrutterer endnu
- Retina Institute of New England
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Walnut Creek, California, Forenede Stater, 94598
- Ikke rekrutterer endnu
- Bay Area Retina Associates - Walnut Creek
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Rekruttering
- Retina Specialists of Colorado - Aurora
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Colorado Springs, Colorado, Forenede Stater, 80909
- Ikke rekrutterer endnu
- Retina Consultants of Southern Colorado P.C.
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Durango, Colorado, Forenede Stater, 81303
- Rekruttering
- Southwest Retina Consultants
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Connecticut
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Greenwich, Connecticut, Forenede Stater, 06830
- Rekruttering
- Coastal Eye- Greenwich
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Waterford, Connecticut, Forenede Stater, 06385
- Ikke rekrutterer endnu
- Retina Institute of New England, PC
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Ikke rekrutterer endnu
- Retina Group of Florida
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Orlando, Florida, Forenede Stater, 32806
- Ikke rekrutterer endnu
- Florida Retina Institute
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Pensacola, Florida, Forenede Stater, 32503
- Rekruttering
- Retinal Specialty Institute
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Plantation, Florida, Forenede Stater, 33324
- Ikke rekrutterer endnu
- Fort Lauderdale Eye Institute (FLEI)-Plantation
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Tampa, Florida, Forenede Stater, 33607
- Rekruttering
- Retina Vitreous Associates of Florida
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Illinois
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Elmhurst, Illinois, Forenede Stater, 60126
- Rekruttering
- Retina Associates, Ltd.
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Lemont, Illinois, Forenede Stater, 60439
- Rekruttering
- University Retina and Macula Associates, PC - Lemont
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Oak Park, Illinois, Forenede Stater, 60304
- Ikke rekrutterer endnu
- Illinois Retina Associates
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Springfield, Illinois, Forenede Stater, 62703
- Ikke rekrutterer endnu
- Springfield Clinic
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Indiana
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Carmel, Indiana, Forenede Stater, 46032
- Ikke rekrutterer endnu
- Midwest Eye Institute
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Maryland
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Chevy Chase, Maryland, Forenede Stater, 20815
- Ikke rekrutterer endnu
- The Retina Group of Washington
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Hagerstown, Maryland, Forenede Stater, 21740
- Ikke rekrutterer endnu
- Cumberland Valley Retina Consultants
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Hagerstown, Maryland, Forenede Stater, 21740
- Ikke rekrutterer endnu
- Mid Atlantic Retina Specialist
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Mississippi
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Madison, Mississippi, Forenede Stater, 39110
- Ikke rekrutterer endnu
- Mississippi Retina Associates
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Southaven, Mississippi, Forenede Stater, 38671
- Rekruttering
- Deep Blue Retina Clinical Research, PLLC
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Missouri
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St Louis, Missouri, Forenede Stater, 63128
- Ikke rekrutterer endnu
- The Retina Institute
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Nevada
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Reno, Nevada, Forenede Stater, 89502
- Rekruttering
- Sierra Eye Associates
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New Jersey
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Bloomfield, New Jersey, Forenede Stater, 07003
- Rekruttering
- Envision Ocular, LLC
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Edison, New Jersey, Forenede Stater, 08820
- Ikke rekrutterer endnu
- NJ Retina
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New York
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New York, New York, Forenede Stater, 10017
- Ikke rekrutterer endnu
- NYU Langone Health
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New York, New York, Forenede Stater, 13088
- Rekruttering
- Retina Vitreous Surgeons of CNY, PC
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Westbury, New York, Forenede Stater, 11590
- Ikke rekrutterer endnu
- Vitreoretinal Consultants of New York (VRCNY)
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28803
- Rekruttering
- Asheville Eye Associates - Retina Division
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Cary, North Carolina, Forenede Stater, 27511
- Ikke rekrutterer endnu
- North Carolina Retina Associates - Cary Office
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Wake Forest, North Carolina, Forenede Stater, 27587
- Ikke rekrutterer endnu
- North Carolina Retina Associates- Wake Forest
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Ohio
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Middleburg Heights, Ohio, Forenede Stater, 44130
- Ikke rekrutterer endnu
- Retina Associates of Cleveland
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Oklahoma
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Edmund, Oklahoma, Forenede Stater, 73013
- Rekruttering
- Retina Vitreous Center
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Oregon
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Portland, Oregon, Forenede Stater, 97233
- Ikke rekrutterer endnu
- EyeHealth Northwest
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater, 18017
- Trukket tilbage
- Mid Atlantic Retina
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Ikke rekrutterer endnu
- Mid Atlantic Retina - Philadelphia
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
- Rekruttering
- Black Hills Regional Eye Institute
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Ikke rekrutterer endnu
- Tennessee Retina
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Texas
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Abilene, Texas, Forenede Stater, 79606
- Ikke rekrutterer endnu
- West Texas Retina Consultants
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Austin, Texas, Forenede Stater, 78750
- Rekruttering
- Austin Clinical Research
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Austin, Texas, Forenede Stater, 78705
- Ikke rekrutterer endnu
- Austin Retina Associates
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Austin, Texas, Forenede Stater, 78705
- Ikke rekrutterer endnu
- Austin Research Center for Retina
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Dallas, Texas, Forenede Stater, 75231
- Rekruttering
- Texas Retina Associate
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Texas Retina Center
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Katy, Texas, Forenede Stater, 77494
- Ikke rekrutterer endnu
- Retina Consultants of Texas - Katy
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The Woodlands, Texas, Forenede Stater, 77384
- Ikke rekrutterer endnu
- Retina Consultants of Texas
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Tyler, Texas, Forenede Stater, 75703
- Rekruttering
- Tyler Retina Consultants
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- The Retina Group of Washington
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Lynchburg, Virginia, Forenede Stater, 24502
- Rekruttering
- Piedmont Eye Center
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Wisconsin
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Wausau, Wisconsin, Forenede Stater, 55403
- Ikke rekrutterer endnu
- Eye Clinic of Wisconsin
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Amagasaki-shi, Japan, 660-8550
- Ikke rekrutterer endnu
- Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
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Fukuoka, Japan, 812-8582
- Ikke rekrutterer endnu
- Kyushu University Hospital
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Fukuoka, Japan, 812-0011
- Ikke rekrutterer endnu
- Hayashi Eye Hospital
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Fukushima, Japan, 960-1295
- Ikke rekrutterer endnu
- Fukushima Medical University Hospital
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Hachioji-shi, Japan, 193-0998
- Ikke rekrutterer endnu
- Tokyo Medical University Hachioji Medical Center
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Kagoshima, Japan, 890-8520
- Ikke rekrutterer endnu
- Kagoshima University Hospital
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Kita-Gun, Japan, 761-0793
- Ikke rekrutterer endnu
- Kagawa University Hospital
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Kobe, Japan, 650-0047
- Ikke rekrutterer endnu
- Kobe City Eye Hospital
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Kyoto, Japan, 606-8507
- Ikke rekrutterer endnu
- Kyoto University Hospital
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Mitaka-shi, Japan, 181-8611
- Ikke rekrutterer endnu
- Kyorin University - Kyorin University Hospital - Mitaka
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Miyazaki, Japan, 889-1692
- Ikke rekrutterer endnu
- University of Miyazaki Hospital
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Nagoya, Japan, 466-8560
- Ikke rekrutterer endnu
- Nagoya University Hospital
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Sakura-shi, Japan, 285-8741
- Ikke rekrutterer endnu
- Toho University Sakura Medical Center
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Tokyo, Japan, 152-8902
- Ikke rekrutterer endnu
- National Hospital Organization Tokyo Medical Center
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Tokyo, Japan, 113-8431
- Ikke rekrutterer endnu
- Juntendo University Hospital
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Ibaraki
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Mito, Ibaraki, Japan, 310-0845
- Ikke rekrutterer endnu
- Kozawa Eye Hospital and Diabetes Center
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Beijing, Kina, 100730
- Ikke rekrutterer endnu
- Beijing Tongren Hospital
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Changchun, Kina, 130041
- Ikke rekrutterer endnu
- The Second Hospital of Jilin University
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Changsha, Kina, 410300
- Ikke rekrutterer endnu
- The Second Xiangya Hospital of Central South University
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Haerbin, Kina, 150001
- Ikke rekrutterer endnu
- The Second Affiliated Hospital of Harbin Medical University
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Hangzhou, Kina, 310015
- Ikke rekrutterer endnu
- Zhejiang Provincial People's Hospital
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Jinan, Kina, 250021
- Ikke rekrutterer endnu
- Eye Hospital of Shandong First Medical University
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Jinan, Kina, 450006
- Ikke rekrutterer endnu
- Zhengzhou Second Peoples Hospital
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Lanzhou, Kina, 730030
- Ikke rekrutterer endnu
- Lanzhou University Second Hospital
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Nanchang, Kina, 330006
- Ikke rekrutterer endnu
- Nanchang University Affiliated Eye Hospital
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Shanghai, Kina, 200080
- Ikke rekrutterer endnu
- Shanghai First People's Hospital
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Shanghai, Kina, 200031
- Ikke rekrutterer endnu
- Fudan University - Eye & ENT Hospital
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Taiyuan, Kina, 030032
- Ikke rekrutterer endnu
- Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital
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Taizhou, Kina, 317000
- Ikke rekrutterer endnu
- Taizhou Hospital of Zhejiang Province
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Tianjin, Kina, 300384
- Ikke rekrutterer endnu
- Tianjin Medical University Eye Hospital
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Weifang, Kina, 261021
- Ikke rekrutterer endnu
- Weifang Eye Hospital
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Wuhan, Kina, 430014
- Ikke rekrutterer endnu
- Huazhong University of Science and Technology-Tongji Medical College-The Central Hospital of Wuhan
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Wuhan, Kina, 430060
- Ikke rekrutterer endnu
- Wuhan University Renmin Hospital (Hubei General Hospital)
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Zhengzhou, Kina, 450003
- Ikke rekrutterer endnu
- Henan Eye Hospital, Henan Provincial People's Hospital
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Arecibo, Puerto Rico, 00612
- Ikke rekrutterer endnu
- Emanuelli Research & Development Center, LLC (ERD)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
5.2 Inclusion Criteria
Individuals eligible to participate in the trial must meet the following inclusion criteria:
General Inclusion Criteria
- Signed informed consent before any protocol-specified assessment is performed
- Ability and willingness to comply with the protocol-specified procedures (including IVT injection) and visits, in the Investigator's judgment
- ≥18 years of age at time of signing informed consent
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- WOCBP must agree to use highly effective contraception from the time of informed consent, through duration of trial participation
- Agree to use a barrier method (e.g., condom) during intercourse for 3 months after Day 1 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period Ocular Inclusion Criteria
- Macular thickening secondary to DME involving the center of the fovea (confirmed by the Reading Center) in the study eye
- Study eye amenable to IVT injection identified
- Presence of intraretinal fluid and/or subretinal fluid secondary to DME
- Decreased visual acuity attributable primarily to DME, as determined by the Investigator
- Demonstrated clinical response to aflibercept and functional stability in the study eye
Exclusion Criteria: Individuals who meet any of the following exclusion criteria will not be eligible to participate:
Ocular Condition
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Macular conditions other than DME
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History or presence of moderate Proliferative Diabetic Retinopathy or worse
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History of retinal detachment in the study eye
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History or presence of active inflammation or infection in either eye
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History or presence of low Intraocular Pressure
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Uncontrolled glaucoma or intraocular hypertension
Ocular Treatments/Interventions:
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Any prior concomitant treatment for DME
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History of prior significant ocular surgery or treatment
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Any prior investigational drug, agent, device, or gene therapy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 4D-150 IVT (3x10^10 vg/eye)
|
If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1 |
|
Aktiv komparator: Active Comparator (AFLB) 2mg IVT
|
EYLEA ® (aflibercept) will be administered at applicable visits |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean change from baseline in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letter score at Week 52
Tidsramme: 52 weeks
|
The minimum and maximum values are: 0 to 100 The higher the value the better the result |
52 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mean annualized number of aflibercept injections after Week 4 through Week 52
Tidsramme: Week 4 through Week 52
|
Minimum 0 maximum 12 One injection per visit, one visit every four weeks |
Week 4 through Week 52
|
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Proportion of participants with a ≥ 2-step improvement from baseline in Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at Week 52
Tidsramme: 52 weeks
|
ETDRS-DRSS is a visual acuity test Results are analyzing using a generalized estimating equations model |
52 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. september 2026
Primær færdiggørelse (Anslået)
1. januar 2029
Studieafslutning (Anslået)
1. januar 2030
Datoer for studieregistrering
Først indsendt
5. oktober 2026
Først indsendt, der opfyldte QC-kriterier
5. oktober 2026
Først opslået (Faktiske)
9. oktober 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4D-150-C005
- 4SIGHT (Anden identifikator: Sponsor)
- 4D-150-C005 (Anden identifikator: Sponsor)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Data obtained through this study may be provided, after deidentification, to qualified researchers with academic interest in DME in compliance with ICMJE policy. Data or samples shared will be coded, with no Protected Health Information included. Additionally, descriptions of the study protocol, Statistical Analysis Plan (SAP), informed consent and clinical study report may be shared publicly. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting after final Clinical Study Report and the data will be made accessible for a duration determined by the Sponsor, and in accordance with ICMJE policy. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and SAP and execution of a Data Sharing Agreement (DSA)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .