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Uno studio per indagare su RO7200220 nell'edema maculare diabetico

17 aprile 2026 aggiornato da: Hoffmann-La Roche

Uno studio di fase II, multicentrico, randomizzato, in doppio cieco, controllato da un comparatore attivo per studiare l'efficacia, la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica di RO7200220 somministrato per via intravitreale in pazienti con edema maculare diabetico

Lo studio BP43445 è uno studio di fase II, multicentrico, randomizzato, in doppio cieco, controllato con comparatore attivo per studiare l'efficacia, la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica di RO7200220 somministrato per via intravitreale in partecipanti con edema maculare diabetico. Verrà scelto un solo occhio come occhio di studio. La durata dello studio sarà fino a 76 settimane.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

394

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Cechia
      • Ostrava, Cechia, 708 52
        • Faculty Hospital Ostrava
      • Prague, Cechia
        • AXON clinical
      • Prague, Cechia, 128 08
        • General Teaching Hospital Prague
      • Prague, Cechia, 100 34
        • Faculty Hospital Kralovske Vinohrady
  • Corea del Sud
      • Daegu, Corea del Sud, 42415
        • Yeungnam University Medical Center
      • Seongnam-si, Corea del Sud, 13605
        • Seoul National University Bundang Hospital
      • Seoul, Corea del Sud, 05505
        • Asan Medical Center
      • Seoul, Corea del Sud, 06351
        • Samsung Medical Center
      • Seoul, Corea del Sud, 07301
        • Kim's Eye Hospital
  • Polonia
      • Gliwice, Polonia, 44-100
        • Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
      • Katowice, Polonia, 40-514
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Polonia, 31-070
        • Centrum Medyczne UNO-MED
      • Lublin, Polonia, 20-079
        • SPSK nr 1 w Lublinie
      • Olsztyn, Polonia, 10-424
        • Centrum Diagnostyki i Mikrochirurgii Oka LENS
      • Rybnik, Polonia, 44-203
        • LensClinic
      • Tarnowskie Góry, Polonia, 42-600
        • Caminomed
  • Porto Rico
      • Arecibo, Porto Rico, 00612
        • Emanuelli Research and Development Center LLC
  • Regno Unito
      • Bristol, Regno Unito, BS1 2LX
        • Bristol Eye Hospital
      • Gloucestershire, Regno Unito, GL1 3NN
        • Gloucestershire Hospitals NHS Foundation Trust
      • Guildford, Regno Unito, GU2 7XX
        • Royal Surrey County Hospital
      • London, Regno Unito, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
      • Newcastle upon Tyne, Regno Unito, NE1 4LP
        • Royal Victoria Infirmary
  • Spagna
      • Zaragoza, Spagna, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • Sant Cugat de Valles, Barcelona, Spagna, 08190
        • Hospital General De Catalunya
    • Madrid
      • Majadahonda, Madrid, Spagna, 28222
        • Hospital Universitario Puerta De Hierro
    • Valencia
      • Burjassot, Valencia, Spagna, 46100
        • Oftalvist Valencia
  • Stati Uniti
    • California
      • Arcadia, California, Stati Uniti, 91006
        • Win Retina
      • Poway, California, Stati Uniti, 92064
        • Retina Consultants, San Diego
      • Sacramento, California, Stati Uniti, 95825
        • Retinal Consultants Med Group
      • Walnut Creek, California, Stati Uniti, 94598
        • Bay Area Retina Associates
    • Colorado
      • Lakewood, Colorado, Stati Uniti, 80228
        • Colorado Retina Associates, PC
    • District of Columbia
      • Washington D.C., District of Columbia, Stati Uniti, 20011-3010
        • Emerson Clinical Research Institute LLC
    • Florida
      • Deerfield Beach, Florida, Stati Uniti, 33064
        • Rand Eye
      • Fort Myers, Florida, Stati Uniti, 33912
        • National Ophthalmic Research Institute
      • Orlando, Florida, Stati Uniti, 32806-1101
        • Florida Retina Institute
      • St. Petersburg, Florida, Stati Uniti, 33607
        • Retina Vitreous Associates of Florida
      • Wesley Chapel, Florida, Stati Uniti, 33544
        • Retina Specialists of Tampa
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40206
        • Butchertown Clinical Trials
    • Maryland
      • Hagerstown, Maryland, Stati Uniti, 21740
        • Cumberland Valley Retina PC
    • Mississippi
      • Southaven, Mississippi, Stati Uniti, 38671
        • Deep Blue Retina PLLC
    • Nevada
      • Reno, Nevada, Stati Uniti, 89502
        • Sierra Eye Associates
    • New York
      • Lynbrook, New York, Stati Uniti, 11563
        • Opthalmic Consultants of LI
      • Rochester, New York, Stati Uniti, 14642
        • University of Rochester Flaum Eye Institute
    • North Carolina
      • Asheville, North Carolina, Stati Uniti, 28803
        • Western Carolina Retinal Associate PA
      • Winston-Salem, North Carolina, Stati Uniti, 27157
        • Wake Forest Baptist Medical Center
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45219
        • Meridian Clinical Research
    • Oregon
      • Eugene, Oregon, Stati Uniti, 97401
        • Verum Research LLC
      • Portland, Oregon, Stati Uniti, 97225
        • EyeHealth Northwest
    • Pennsylvania
      • Erie, Pennsylvania, Stati Uniti, 16507
        • Erie Retinal Surgery
      • Kingston, Pennsylvania, Stati Uniti, 18704
        • Eye Care Specialists, PC
      • Sewickley, Pennsylvania, Stati Uniti, 15143
        • Sewickley Eye Group
    • South Carolina
      • Ladson, South Carolina, Stati Uniti, 29456
        • Charleston Neuroscience Institute
    • South Dakota
      • Rapid City, South Dakota, Stati Uniti, 57701
        • Black Hills Eye Institute
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37203
        • Retina Consultants of Nashville
    • Texas
      • Arlington, Texas, Stati Uniti, 75075
        • Texas Retina Associates
      • Austin, Texas, Stati Uniti, 78750
        • Austin Clinical Research LLC
      • Bellaire, Texas, Stati Uniti, 77401
        • Retina Consultants of Texas
      • McAllen, Texas, Stati Uniti, 78503
        • Valley Retina Institute P.A.
      • The Woodlands, Texas, Stati Uniti, 78240
        • Retina Consultants of Texas
      • Willow Park, Texas, Stati Uniti, 76087
        • Strategic Clinical Research Group, LLC
    • Virginia
      • Lynchburg, Virginia, Stati Uniti, 24502
        • Piedmont Eye Center
      • Norfolk, Virginia, Stati Uniti, 23502
        • Wagner Macula & Retina Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Diagnosi di diabete mellito (Tipo 1 o Tipo 2)
  • Ispessimento maculare secondario all'edema maculare diabetico (DME) che coinvolge il centro della macula
  • Diminuzione dell'acuità visiva attribuibile principalmente al DME
  • Capacità e disponibilità a fornire il consenso informato scritto e a rispettare il protocollo dello studio
  • Disponibilità a consentire la raccolta di Umori Acqueosi
  • Per le donne in età fertile: consenso a mantenere l'astinenza o utilizzare almeno un metodo contraccettivo altamente efficace che si traduca in un tasso di fallimento di

Criteri di esclusione:

  • Emoglobina A1c (HbA1c) superiore a (>) 12%
  • Pressione sanguigna incontrollata, definita come un valore sistolico superiore a (>) 180 millimetri di mercurio (mmHg) e/o un valore diastolico > 100 mmHg mentre un paziente è a riposo
  • - Attualmente incinta o in allattamento o intenzione di rimanere incinta durante lo studio
  • Precedente trattamento con fotocoagulazione panretinica o laser maculare all'occhio dello studio
  • Qualsiasi trattamento con corticosteroidi intraoculari o perioculari nelle ultime 16 settimane prima del Giorno 1 nell'occhio dello studio
  • - Precedente impianto Iluvien o Retisert entro 3 anni prima del giorno 1 nell'occhio dello studio
  • Trattamento precedente o concomitante con terapia anti-VEGF entro 8 settimane prima del Giorno 1 nell'occhio dello studio; Vabysmo^TM entro 16 settimane prima del Giorno 1, Beovu® precedente non è consentito
  • Precedente somministrazione di IVT brolucizumab (Beovu®): mai; RO7200220:
  • Qualsiasi retinopatia diabetica proliferativa
  • Infezione intraoculare o perioculare attiva o infiammazione intraoculare attiva nell'occhio dello studio
  • Qualsiasi malattia oculare attuale o pregressa diversa dal DME che possa confondere la valutazione della macula o influenzare la visione centrale nell'occhio dello studio
  • Qualsiasi condizione oculare attuale che, secondo l'opinione dello sperimentatore, sta attualmente causando o potrebbe contribuire alla perdita irreversibile della vista a causa di una causa diversa dal DME nell'occhio dello studio
  • Potrebbero essere applicati altri criteri di inclusione/esclusione specificati dal protocollo

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Braccio D: 0,5 mg di ranibizumab Q4W
I partecipanti riceveranno ranibizumab 0,5 mg, mediante iniezione IVT, il giorno 1 e Q4W, fino alla settimana 44 per un totale di 12 iniezioni.
Droga: Ranibizumab
Ranibizumab 0,5 mg verrà somministrato ai partecipanti mediante iniezione IVT, come specificato nel braccio di trattamento.
Altri nomi:
  • Lucentis
Sperimentale: Braccio A: 0,25 mg di Vamikibart Q8W
I partecipanti riceveranno vamikibart 0,25 milligrammi (mg), mediante iniezione intravitreale (IVT), il giorno 1 e ogni 8 settimane (Q8W), fino alla settimana 44, per un totale di 6 iniezioni. Durante le visite dello studio durante le quali non verrà somministrato alcun farmaco in studio verrà somministrata una procedura fittizia per mantenere il mascheramento tra i bracci di trattamento.
Altro: Procedura fittizia
Sham è una procedura che imita un'iniezione IVT e prevede che l'estremità smussata di una siringa vuota (senza ago) venga premuta contro l'occhio anestetizzato. La procedura fittizia verrà somministrata ai partecipanti nei bracci Q8W alle visite applicabili per mantenere il mascheramento tra i bracci di trattamento.
Droga: Vamikibart
Vamikibart sarà somministrato mediante iniezione IVT come specificato in ciascun braccio di trattamento.
Altri nomi:
  • RO7200220
Sperimentale: Braccio B: 1,0 mg di Vamikibart Q8W
I partecipanti riceveranno vamikibart 1,0 mg, mediante iniezione IVT, il giorno 1 e Q8W, fino alla settimana 44, per un totale di 6 iniezioni. Durante le visite dello studio durante le quali non verrà somministrato alcun farmaco in studio verrà somministrata una procedura fittizia per mantenere il mascheramento tra i bracci di trattamento.
Altro: Procedura fittizia
Sham è una procedura che imita un'iniezione IVT e prevede che l'estremità smussata di una siringa vuota (senza ago) venga premuta contro l'occhio anestetizzato. La procedura fittizia verrà somministrata ai partecipanti nei bracci Q8W alle visite applicabili per mantenere il mascheramento tra i bracci di trattamento.
Droga: Vamikibart
Vamikibart sarà somministrato mediante iniezione IVT come specificato in ciascun braccio di trattamento.
Altri nomi:
  • RO7200220
Sperimentale: Braccio C: 1,0 mg di Vamikibart Q4W
I partecipanti riceveranno vamikibart 1,0 mg, mediante iniezione IVT, il giorno 1 e ogni 4 settimane (Q4W), fino alla settimana 44 per un totale di 12 iniezioni.
Droga: Vamikibart
Vamikibart sarà somministrato mediante iniezione IVT come specificato in ciascun braccio di trattamento.
Altri nomi:
  • RO7200220

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Systemic and Ocular Adverse Events (AEs)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Investigatori

  • Direttore dello studio: Clinical Trials, Hoffmann-La Roche

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

31 dicembre 2021

Completamento primario (Effettivo)

6 novembre 2024

Completamento dello studio (Effettivo)

21 aprile 2025

Date di iscrizione allo studio

Primo inviato

8 dicembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

8 dicembre 2021

Primo Inserito (Effettivo)

9 dicembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

I ricercatori qualificati possono richiedere l'accesso ai dati dei singoli pazienti attraverso la piattaforma di richiesta dei dati degli studi clinici (www.vivli.org/). Ulteriori dettagli sui criteri di Roche per gli studi ammissibili sono disponibili qui (https://vivli.org/ourmember/roche/).

Per ulteriori dettagli sulla politica globale di Roche sulla condivisione delle informazioni cliniche e su come richiedere l'accesso ai documenti relativi agli studi clinici, vedere qui (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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