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En undersøgelse for at undersøge RO7200220 i diabetisk makulært ødem

17. april 2026 opdateret af: Hoffmann-La Roche

En fase II, multicenter, randomiseret, dobbeltmasket, aktiv komparatorkontrolleret undersøgelse for at undersøge effektiviteten, sikkerheden, tolerabiliteten, farmakokinetikken og farmakodynamikken af ​​RO7200220 administreret intravitrealt hos patienter med diabetisk makulaødem

Undersøgelse BP43445 er en fase II, multicenter, randomiseret, dobbeltmasket, aktiv komparatorkontrolleret undersøgelse til undersøgelse af effektivitet, sikkerhed, tolerabilitet, farmakokinetik og farmakodynamik af RO7200220 administreret intravitrealt hos deltagere med diabetisk makulaødem. Kun ét øje vil blive valgt som studieøje. Undersøgelsens varighed vil vare op til 76 uger.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

394

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1015ABO
        • Organizacion Medica de Investigacion
      • Capital Federal, Argentina, C1120AAN
        • Oftalmos
      • Capital Federal, Argentina, C1116
        • Centro Oftalmologico Dr. Charles S.A.
      • Ciudad Autonoma Buenos Aires, Argentina, C1061AAE
        • Buenos Aires Mácula
      • Córdoba, Argentina
        • Centro Privado de Ojos Romagosa
      • Lomas de Zamora, Argentina
        • Centro de ojos Loria
      • Mendoza, Argentina, M5500GGK
        • OFTAR
      • Rosario, Argentina, S2000CTC
        • Microcirugía Ocular S.A
      • Rosario, Argentina, S2000DLA
        • Grupo Laser Vision
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K2B 7E9
        • Retina Institute of Ottawa
      • Toronto, Ontario, Canada, M3C 0G9
        • Toronto Retina Institute
    • Quebec
      • Boisbriand, Quebec, Canada, J7H 0E8
        • Institut De L'Oeil Des Laurentides
  • Det Forenede Kongerige
      • Bristol, Det Forenede Kongerige, BS1 2LX
        • Bristol Eye Hospital
      • Gloucestershire, Det Forenede Kongerige, GL1 3NN
        • Gloucestershire Hospitals NHS Foundation Trust
      • Guildford, Det Forenede Kongerige, GU2 7XX
        • Royal Surrey County Hospital
      • London, Det Forenede Kongerige, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
      • Newcastle upon Tyne, Det Forenede Kongerige, NE1 4LP
        • Royal Victoria Infirmary
  • Forenede Stater
    • California
      • Arcadia, California, Forenede Stater, 91006
        • Win Retina
      • Poway, California, Forenede Stater, 92064
        • Retina Consultants, San Diego
      • Sacramento, California, Forenede Stater, 95825
        • Retinal Consultants Med Group
      • Walnut Creek, California, Forenede Stater, 94598
        • Bay Area Retina Associates
    • Colorado
      • Lakewood, Colorado, Forenede Stater, 80228
        • Colorado Retina Associates, PC
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20011-3010
        • Emerson Clinical Research Institute LLC
    • Florida
      • Deerfield Beach, Florida, Forenede Stater, 33064
        • Rand Eye
      • Fort Myers, Florida, Forenede Stater, 33912
        • National Ophthalmic Research Institute
      • Orlando, Florida, Forenede Stater, 32806-1101
        • Florida Retina Institute
      • St. Petersburg, Florida, Forenede Stater, 33607
        • Retina Vitreous Associates of Florida
      • Wesley Chapel, Florida, Forenede Stater, 33544
        • Retina Specialists of Tampa
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40206
        • Butchertown Clinical Trials
    • Maryland
      • Hagerstown, Maryland, Forenede Stater, 21740
        • Cumberland Valley Retina PC
    • Mississippi
      • Southaven, Mississippi, Forenede Stater, 38671
        • Deep Blue Retina PLLC
    • Nevada
      • Reno, Nevada, Forenede Stater, 89502
        • Sierra Eye Associates
    • New York
      • Lynbrook, New York, Forenede Stater, 11563
        • Opthalmic Consultants of LI
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester Flaum Eye Institute
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28803
        • Western Carolina Retinal Associate PA
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest Baptist Medical Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Meridian Clinical Research
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401
        • Verum Research LLC
      • Portland, Oregon, Forenede Stater, 97225
        • EyeHealth Northwest
    • Pennsylvania
      • Erie, Pennsylvania, Forenede Stater, 16507
        • Erie Retinal Surgery
      • Kingston, Pennsylvania, Forenede Stater, 18704
        • Eye Care Specialists, PC
      • Sewickley, Pennsylvania, Forenede Stater, 15143
        • Sewickley Eye Group
    • South Carolina
      • Ladson, South Carolina, Forenede Stater, 29456
        • Charleston Neuroscience Institute
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Black Hills Eye Institute
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Retina Consultants of Nashville
    • Texas
      • Arlington, Texas, Forenede Stater, 75075
        • Texas Retina Associates
      • Austin, Texas, Forenede Stater, 78750
        • Austin Clinical Research LLC
      • Bellaire, Texas, Forenede Stater, 77401
        • Retina Consultants of Texas
      • McAllen, Texas, Forenede Stater, 78503
        • Valley Retina Institute P.A.
      • The Woodlands, Texas, Forenede Stater, 78240
        • Retina Consultants of Texas
      • Willow Park, Texas, Forenede Stater, 76087
        • Strategic Clinical Research Group, LLC
    • Virginia
      • Lynchburg, Virginia, Forenede Stater, 24502
        • Piedmont Eye Center
      • Norfolk, Virginia, Forenede Stater, 23502
        • Wagner Macula & Retina Center
  • Polen
      • Gliwice, Polen, 44-100
        • Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
      • Katowice, Polen, 40-514
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Polen, 31-070
        • Centrum Medyczne UNO-MED
      • Lublin, Polen, 20-079
        • SPSK nr 1 w Lublinie
      • Olsztyn, Polen, 10-424
        • Centrum Diagnostyki i Mikrochirurgii Oka LENS
      • Rybnik, Polen, 44-203
        • LensClinic
      • Tarnowskie Góry, Polen, 42-600
        • Caminomed
  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Emanuelli Research and Development Center LLC
  • Spanien
      • Zaragoza, Spanien, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • Sant Cugat de Valles, Barcelona, Spanien, 08190
        • Hospital General De Catalunya
    • Madrid
      • Majadahonda, Madrid, Spanien, 28222
        • Hospital Universitario Puerta De Hierro
    • Valencia
      • Burjassot, Valencia, Spanien, 46100
        • Oftalvist Valencia
  • Sydkorea
      • Daegu, Sydkorea, 42415
        • Yeungnam University Medical Center
      • Seongnam-si, Sydkorea, 13605
        • Seoul National University Bundang Hospital
      • Seoul, Sydkorea, 05505
        • Asan Medical Center
      • Seoul, Sydkorea, 06351
        • Samsung Medical Center
      • Seoul, Sydkorea, 07301
        • Kim's Eye Hospital
  • Tjekkiet
      • Ostrava, Tjekkiet, 708 52
        • Faculty Hospital Ostrava
      • Prague, Tjekkiet
        • AXON clinical
      • Prague, Tjekkiet, 128 08
        • General Teaching Hospital Prague
      • Prague, Tjekkiet, 100 34
        • Faculty Hospital Kralovske Vinohrady

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

Beskrivelse

Inklusionskriterier:

  • Diagnose af diabetes mellitus (type 1 eller type 2)
  • Makula fortykkelse sekundært til diabetisk makulaødem (DME), der involverer midten af ​​makula
  • Nedsat synsstyrke, der primært kan tilskrives DME
  • Evne og vilje til at give skriftligt informeret samtykke og til at overholde undersøgelsesprotokollen
  • Vilje til at tillade indsamling af vandig humor
  • For kvinder i den fødedygtige alder: aftale om at forblive afholdende eller bruge mindst én yderst effektiv præventionsmetode, der resulterer i en fejlrate på

Ekskluderingskriterier:

  • Hæmoglobin A1c (HbA1c) på mere end (>) 12 %
  • Ukontrolleret blodtryk, defineret som en systolisk værdi større end (>)180 millimeter kviksølv (mmHg) og/eller en diastolisk værdi >100 mmHg, mens en patient er i hvile
  • Er i øjeblikket gravid eller ammer, eller har til hensigt at blive gravid under undersøgelsen
  • Forudgående behandling med panretinal fotokoagulation eller makulær laser til undersøgelsesøjet
  • Enhver intraokulær eller periokulær kortikosteroidbehandling inden for de sidste 16 uger før dag 1 til undersøgelsesøjet
  • Tidligere Iluvien- eller Retisert-implantater inden for 3 år før dag 1 til undersøgelsesøjet
  • Forudgående eller samtidig behandling med anti-VEGF-behandling inden for 8 uger før dag 1 til undersøgelsesøjet; Vabysmo^TM inden for 16 uger før dag 1, tidligere Beovu® er ikke tilladt
  • Tidligere administration af IVT brolucizumab (Beovu®): nogensinde; RO7200220:
  • Enhver proliferativ diabetisk retinopati
  • Aktiv intraokulær eller periokulær infektion eller aktiv intraokulær inflammation i undersøgelsesøjet
  • Enhver aktuel eller historie med øjensygdom bortset fra DME, der kan forvirre vurderingen af ​​macula eller påvirke det centrale syn i undersøgelsesøjet
  • Enhver aktuel okulær tilstand, som efter investigatorens mening i øjeblikket forårsager eller kan forventes at bidrage til irreversibelt synstab på grund af en anden årsag end DME i undersøgelsesøjet
  • Andre protokolspecificerede inklusions-/udelukkelseskriterier kan være gældende

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm D: 0,5 mg Ranibizumab Q4W
Deltagerne vil modtage ranibizumab 0,5 mg ved IVT-injektion på dag 1 og Q4W op til uge 44 for i alt 12 injektioner.
Medicin: Ranibizumab
Ranibizumab 0,5 mg vil blive administreret til deltagerne ved IVT-injektion, som specificeret i behandlingsarmen.
Andre navne:
  • Lucentis
Eksperimentel: Arm A: 0,25 mg Vamikibart Q8W
Deltagerne vil modtage vamikibart 0,25 milligram (mg), ved intravitreal (IVT) injektion, på dag 1 og hver 8. uge (Q8W), op til uge 44, for i alt 6 injektioner. En sham-procedure vil blive administreret under undersøgelsesbesøg, hvor der ikke indgives undersøgelseslægemiddel for at opretholde maskering mellem behandlingsarmene.
Andet: Sham procedure
Sham er en procedure, der efterligner en IVT-injektion og involverer den stumpe ende af en tom sprøjte (uden en nål) presset mod det bedøvede øje. Sham-proceduren vil blive administreret til deltagere i Q8W-armene ved relevante besøg for at opretholde maskering mellem behandlingsarmene.
Medicin: Vamikibart
Vamikibart vil blive administreret ved IVT-injektion som specificeret i hver behandlingsarm.
Andre navne:
  • RO7200220
Eksperimentel: Arm B: 1,0 mg Vamikibart Q8W
Deltagerne vil modtage vamikibart 1,0 mg, ved IVT-injektion, på dag 1 og Q8W, op til uge 44, for i alt 6 injektioner. En sham-procedure vil blive administreret under undersøgelsesbesøg, hvor der ikke indgives undersøgelseslægemiddel for at opretholde maskering mellem behandlingsarmene.
Andet: Sham procedure
Sham er en procedure, der efterligner en IVT-injektion og involverer den stumpe ende af en tom sprøjte (uden en nål) presset mod det bedøvede øje. Sham-proceduren vil blive administreret til deltagere i Q8W-armene ved relevante besøg for at opretholde maskering mellem behandlingsarmene.
Medicin: Vamikibart
Vamikibart vil blive administreret ved IVT-injektion som specificeret i hver behandlingsarm.
Andre navne:
  • RO7200220
Eksperimentel: Arm C: 1,0 mg Vamikibart Q4W
Deltagerne vil modtage vamikibart 1,0 mg ved IVT-injektion på dag 1 og hver 4. uge (Q4W), op til uge 44 for i alt 12 injektioner.
Medicin: Vamikibart
Vamikibart vil blive administreret ved IVT-injektion som specificeret i hver behandlingsarm.
Andre navne:
  • RO7200220

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
Tidsramme: Baseline, Weeks 44 and 48
The BCVA, at a starting test distance of 4 meters (m), was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified early treatment diabetic retinopathy study [ETDRS] charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Systemic and Ocular Adverse Events (AEs)
Tidsramme: Up to Week 72
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs include all non-ocular AEs. Only one eye was selected as the study eye, while the other was referred to as the fellow eye.
Up to Week 72
Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants
Tidsramme: Baseline, Weeks 44 and 48
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48
Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 44 and 48
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
Tidsramme: Baseline, Weeks 32 and 36
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
Tidsramme: Baseline, Weeks 32 and 36
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 32 and 36
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants
Tidsramme: Baseline, Weeks 20 and 24
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants
Tidsramme: Baseline, Weeks 20 and 24
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 20 and 24
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
Tidsramme: From baseline up to Week 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
From baseline up to Week 72
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
Tidsramme: From baseline up to Week 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
From baseline up to Week 72
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants
Tidsramme: Baseline, Weeks 44 and 48
CST was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE), measured using Spectral Domain-Optical Coherence Tomography (SD-OCT). This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants
Tidsramme: Baseline, Weeks 44 and 48
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 44 and 48
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants
Tidsramme: Baseline, Weeks 32 and 36
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants
Tidsramme: Baseline, Weeks 32 and 36
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 32 and 36
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants
Tidsramme: Baseline, Weeks 20 and 24
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants
Tidsramme: Baseline, Weeks 20 and 24
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 20 and 24
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in CST Over Time, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Absence of DME was defined as CST < 325 µm for spectralis SD-OCT, or < 315 μm for cirrus SD-OCT or topcon SD-OCT. SD-OCT was performed on a Spectralis instrument. Percentages have been summarized.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population
Tidsramme: Baseline, Weeks 4, 12, 24, 36, 48, and 72
The absence of IRF in the study eye (defined as IRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with the absence of IRF at the foveal center were reported. Percentages have been summarized.
Baseline, Weeks 4, 12, 24, 36, 48, and 72
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population
Tidsramme: Baseline, Weeks 4, 12, 24, 36, 48, and 72
The absence of SRF in the study eye (defined as SRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with absence of SRF at the foveal center were reported. Percentages have been summarized.
Baseline, Weeks 4, 12, 24, 36, 48, and 72

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Efterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

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)

31. december 2021

Primær færdiggørelse (Faktiske)

6. november 2024

Studieafslutning (Faktiske)

21. april 2025

Datoer for studieregistrering

Først indsendt

8. december 2021

Først indsendt, der opfyldte QC-kriterier

8. december 2021

Først opslået (Faktiske)

9. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BP43445
  • 2021-003756-16 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til data på individuelt patientniveau via platformen for anmodninger om kliniske undersøgelsesdata (www.vivli.org/). Yderligere detaljer om Roches kriterier for kvalificerede undersøgelser er tilgængelige her (https://vivli.org/ourmember/roche/).

For yderligere detaljer om Roches globale politik om deling af klinisk information og hvordan man anmoder om adgang til relaterede kliniske undersøgelsesdokumenter, se her (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm

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 .

Abonner