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Um estudo para investigar o RO7200220 no edema macular diabético

17 de abril de 2026 atualizado por: Hoffmann-La Roche

Um estudo de fase II, multicêntrico, randomizado, duplamente mascarado, controlado por comparador ativo para investigar a eficácia, segurança, tolerabilidade, farmacocinética e farmacodinâmica do RO7200220 administrado por via intravítrea em pacientes com edema macular diabético

O estudo BP43445 é um estudo de fase II, multicêntrico, randomizado, duplo-cego, controlado por comparador ativo para investigar a eficácia, segurança, tolerabilidade, farmacocinética e farmacodinâmica do RO7200220 administrado por via intravítrea em participantes com edema macular diabético. Apenas um olho será escolhido como o olho do estudo. A duração do estudo será de até 76 semanas.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

394

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Diagnóstico de diabetes mellitus (tipo 1 ou tipo 2)
  • Espessamento macular secundário a edema macular diabético (EMD) envolvendo o centro da mácula
  • Diminuição da acuidade visual atribuível principalmente ao EMD
  • Capacidade e vontade de fornecer consentimento informado por escrito e cumprir o protocolo do estudo
  • Vontade de permitir a coleta de humor aquoso
  • Para mulheres com potencial para engravidar: concordância em permanecer abstinente ou usar pelo menos um método contraceptivo altamente eficaz que resulte em uma taxa de falha de

Critério de exclusão:

  • Hemoglobina A1c (HbA1c) superior a (>) 12%
  • Pressão arterial não controlada, definida como um valor sistólico superior a (>)180 milímetros de mercúrio (mmHg) e/ou um valor diastólico >100 mmHg enquanto o paciente está em repouso
  • Atualmente grávida ou amamentando, ou pretende engravidar durante o estudo
  • Tratamento prévio com panfotocoagulação retiniana ou laser macular no olho do estudo
  • Qualquer tratamento com corticosteroide intraocular ou periocular nas últimas 16 semanas antes do Dia 1 para o olho do estudo
  • Implantes anteriores de Iluvien ou Retisert dentro de 3 anos antes do Dia 1 no olho do estudo
  • Tratamento prévio ou concomitante com terapia anti-VEGF dentro de 8 semanas antes do Dia 1 para o olho do estudo; Vabysmo^TM dentro de 16 semanas antes do Dia 1, Beovu® anterior não é permitido
  • Administração prévia de brolucizumabe IVT (Beovu®): nunca; RO7200220:
  • Qualquer retinopatia diabética proliferativa
  • Infecção intraocular ou periocular ativa ou inflamação intraocular ativa no olho do estudo
  • Qualquer doença ocular atual ou história que não seja EMD que possa confundir a avaliação da mácula ou afetar a visão central no olho do estudo
  • Qualquer condição ocular atual que, na opinião do investigador, esteja causando ou possa contribuir para a perda irreversível da visão devido a uma causa diferente de EMD no olho do estudo
  • Outros critérios de inclusão/exclusão especificados pelo protocolo podem ser aplicados

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Braço D: 0,5 mg de Ranibizumabe Q4W
Os participantes receberão ranibizumabe 0,5 mg, por injeção IVT, no Dia 1 e Q4W, até a Semana 44 para um total de 12 injeções.
Medicamento: Ranibizumabe
Ranibizumab 0,5 mg será administrado aos participantes por injeção IVT, conforme especificado no braço de tratamento.
Outros nomes:
  • Lucentis
Experimental: Braço A: 0,25 mg Vamikibart Q8W
Os participantes receberão vamikibart 0,25 miligramas (mg), por injeção intravítrea (IVT), no Dia 1 e a cada 8 semanas (Q8W), até a Semana 44, para um total de 6 injeções. Um procedimento simulado será administrado durante as visitas do estudo nas quais nenhum medicamento do estudo é administrado para manter o mascaramento entre os braços de tratamento.
Outro: Procedimento Simulado
Simulação é um procedimento que imita uma injeção IVT e envolve a ponta romba de uma seringa vazia (sem agulha) sendo pressionada contra o olho anestesiado. O procedimento simulado será administrado aos participantes nos braços Q8W nas visitas aplicáveis ​​para manter o mascaramento entre os braços de tratamento.
Medicamento: Vamikibart
Vamikibart será administrado por injeção IVT conforme especificado em cada braço de tratamento.
Outros nomes:
  • RO7200220
Experimental: Braço B: 1,0 mg Vamikibart Q8W
Os participantes receberão vamikibart 1,0 mg, por injeção IVT, no Dia 1 e Q8W, até a semana 44, para um total de 6 injeções. Um procedimento simulado será administrado durante as visitas do estudo nas quais nenhum medicamento do estudo é administrado para manter o mascaramento entre os braços de tratamento.
Outro: Procedimento Simulado
Simulação é um procedimento que imita uma injeção IVT e envolve a ponta romba de uma seringa vazia (sem agulha) sendo pressionada contra o olho anestesiado. O procedimento simulado será administrado aos participantes nos braços Q8W nas visitas aplicáveis ​​para manter o mascaramento entre os braços de tratamento.
Medicamento: Vamikibart
Vamikibart será administrado por injeção IVT conforme especificado em cada braço de tratamento.
Outros nomes:
  • RO7200220
Experimental: Braço C: 1,0 mg Vamikibart Q4W
Os participantes receberão vamikibart 1,0 mg, por injeção IVT, no Dia 1 e a cada 4 semanas (Q4W), até a Semana 44, para um total de 12 injeções.
Medicamento: Vamikibart
Vamikibart será administrado por injeção IVT conforme especificado em cada braço de tratamento.
Outros nomes:
  • RO7200220

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Systemic and Ocular Adverse Events (AEs)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoffmann-La Roche

Investigadores

  • Diretor de estudo: Clinical Trials, Hoffmann-La Roche

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

31 de dezembro de 2021

Conclusão Primária (Real)

6 de novembro de 2024

Conclusão do estudo (Real)

21 de abril de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

8 de dezembro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de dezembro de 2021

Primeira postagem (Real)

9 de dezembro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Pesquisadores qualificados podem solicitar acesso a dados individuais de pacientes por meio da plataforma de solicitação de dados de estudos clínicos (www.vivli.org/). Mais detalhes sobre os critérios da Roche para estudos elegíveis estão disponíveis aqui (https://vivli.org/ourmember/roche/).

Para obter mais detalhes sobre a Política Global da Roche sobre o Compartilhamento de Informações Clínicas e como solicitar acesso a documentos de estudos clínicos relacionados, consulte aqui (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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