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Un estudio para investigar RO7200220 en edema macular diabético

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

Estudio de fase II, multicéntrico, aleatorizado, con doble enmascaramiento, controlado con un comparador activo para investigar la eficacia, seguridad, tolerabilidad, farmacocinética y farmacodinámica de RO7200220 administrado por vía intravítrea en pacientes con edema macular diabético

El estudio BP43445 es un estudio de fase II, multicéntrico, aleatorizado, doble ciego, controlado con un comparador activo para investigar la eficacia, seguridad, tolerabilidad, farmacocinética y farmacodinámica de RO7200220 administrado por vía intravítrea en participantes con edema macular diabético. Solo se elegirá un ojo como ojo de estudio. La duración del estudio será de hasta 76 semanas.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

394

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • 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
  • Chequia
      • Ostrava, Chequia, 708 52
        • Faculty Hospital Ostrava
      • Prague, Chequia
        • AXON clinical
      • Prague, Chequia, 128 08
        • General Teaching Hospital Prague
      • Prague, Chequia, 100 34
        • Faculty Hospital Kralovske Vinohrady
  • Corea del Sur
      • Daegu, Corea del Sur, 42415
        • Yeungnam University Medical Center
      • Seongnam-si, Corea del Sur, 13605
        • Seoul National University Bundang Hospital
      • Seoul, Corea del Sur, 05505
        • Asan Medical Center
      • Seoul, Corea del Sur, 06351
        • Samsung Medical Center
      • Seoul, Corea del Sur, 07301
        • Kim's Eye Hospital
  • España
      • Zaragoza, España, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • Sant Cugat de Valles, Barcelona, España, 08190
        • Hospital General De Catalunya
    • Madrid
      • Majadahonda, Madrid, España, 28222
        • Hospital Universitario Puerta De Hierro
    • Valencia
      • Burjassot, Valencia, España, 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
  • 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
  • Puerto Rico
      • Arecibo, Puerto 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Diagnóstico de diabetes mellitus (Tipo 1 o Tipo 2)
  • Engrosamiento macular secundario a edema macular diabético (DME) que involucra el centro de la mácula
  • Disminución de la agudeza visual atribuible principalmente a DME
  • Capacidad y voluntad de dar su consentimiento informado por escrito y de cumplir con el protocolo del estudio
  • Voluntad de permitir la recopilación de Humor Acuoso
  • Para mujeres en edad fértil: acuerdo de permanecer abstinente o usar al menos un método anticonceptivo altamente efectivo que resulte en una tasa de fracaso de

Criterio de exclusión:

  • Hemoglobina A1c (HbA1c) de más de (>) 12%
  • Presión arterial no controlada, definida como un valor sistólico superior a (>) 180 milímetros de mercurio (mmHg) y/o un valor diastólico > 100 mmHg mientras el paciente está en reposo
  • Actualmente embarazada o amamantando, o tiene la intención de quedar embarazada durante el estudio
  • Tratamiento previo con fotocoagulación panretiniana o láser macular al ojo de estudio
  • Cualquier tratamiento con corticosteroides intraoculares o perioculares en las últimas 16 semanas antes del día 1 en el ojo del estudio
  • Implantes anteriores de Iluvien o Retisert en los 3 años anteriores al día 1 del ojo del estudio
  • Tratamiento previo o concomitante con terapia anti-VEGF dentro de las 8 semanas anteriores al día 1 en el ojo del estudio; Vabysmo^TM dentro de las 16 semanas anteriores al Día 1, no se permite Beovu® anterior
  • Administración previa de IVT brolucizumab (Beovu®): alguna vez; RO7200220:
  • Cualquier retinopatía diabética proliferativa
  • Infección intraocular o periocular activa o inflamación intraocular activa en el ojo del estudio
  • Cualquier enfermedad ocular actual o anterior que no sea EMD que pueda confundir la evaluación de la mácula o afectar la visión central en el ojo del estudio
  • Cualquier condición ocular actual que, en opinión del investigador, esté causando actualmente o se pueda esperar que contribuya a la pérdida irreversible de la visión debido a una causa distinta al EMD en el ojo del estudio.
  • Pueden aplicarse otros criterios de inclusión/exclusión especificados en el protocolo

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Brazo D: 0,5 mg de ranibizumab Q4W
Los participantes recibirán ranibizumab 0,5 mg, mediante inyección IVT, el día 1 y Q4W, hasta la semana 44 para un total de 12 inyecciones.
Droga: Ranibizumab
Ranibizumab 0,5 mg se administrará a los participantes mediante inyección IVT, como se especifica en el brazo de tratamiento.
Otros nombres:
  • Lucentis
Experimental: Grupo A: 0,25 mg de Vamikibart Q8W
Los participantes recibirán vamikibart 0,25 miligramos (mg), mediante inyección intravítrea (IVT), el día 1 y cada octava semana (Q8W), hasta la semana 44, para un total de 6 inyecciones. Se administrará un procedimiento simulado durante las visitas del estudio en las que no se administra ningún fármaco del estudio para mantener el enmascaramiento entre los brazos de tratamiento.
Otro: Procedimiento simulado
El simulacro es un procedimiento que imita una inyección IVT e involucra el extremo romo de una jeringa vacía (sin aguja) que se presiona contra el ojo anestesiado. El procedimiento simulado se administrará a los participantes en los brazos Q8W en las visitas correspondientes para mantener el enmascaramiento entre los brazos de tratamiento.
Droga: Vamikibart
Vamikibart se administrará mediante inyección IVT como se especifica en cada grupo de tratamiento.
Otros nombres:
  • RO7200220
Experimental: Grupo B: 1,0 mg de Vamikibart Q8W
Los participantes recibirán vamikibart 1,0 mg, mediante inyección IVT, el día 1 y cada 8 semanas, hasta la semana 44, para un total de 6 inyecciones. Se administrará un procedimiento simulado durante las visitas del estudio en las que no se administra ningún fármaco del estudio para mantener el enmascaramiento entre los brazos de tratamiento.
Otro: Procedimiento simulado
El simulacro es un procedimiento que imita una inyección IVT e involucra el extremo romo de una jeringa vacía (sin aguja) que se presiona contra el ojo anestesiado. El procedimiento simulado se administrará a los participantes en los brazos Q8W en las visitas correspondientes para mantener el enmascaramiento entre los brazos de tratamiento.
Droga: Vamikibart
Vamikibart se administrará mediante inyección IVT como se especifica en cada grupo de tratamiento.
Otros nombres:
  • RO7200220
Experimental: Grupo C: 1,0 mg de Vamikibart cada 4 semanas
Los participantes recibirán vamikibart 1,0 mg, mediante inyección IVT, el día 1 y cada 4 semanas (Q4W), hasta la semana 44 para un total de 12 inyecciones.
Droga: Vamikibart
Vamikibart se administrará mediante inyección IVT como se especifica en cada grupo de tratamiento.
Otros nombres:
  • RO7200220

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Systemic and Ocular Adverse Events (AEs)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hoffmann-La Roche

Investigadores

  • Director de estudio: Clinical Trials, Hoffmann-La Roche

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de diciembre de 2021

Finalización primaria (Actual)

6 de noviembre de 2024

Finalización del estudio (Actual)

21 de abril de 2025

Fechas de registro del estudio

Enviado por primera vez

8 de diciembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

8 de diciembre de 2021

Publicado por primera vez (Actual)

9 de diciembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Los investigadores calificados pueden solicitar acceso a datos de pacientes individuales a través de la plataforma de solicitud de datos de estudios clínicos (www.vivli.org/). Más detalles sobre los criterios de Roche para estudios elegibles están disponibles aquí (https://vivli.org/ourmember/roche/).

Para obtener más detalles sobre la Política global de Roche sobre el intercambio de información clínica y cómo solicitar acceso a documentos de estudios clínicos relacionados, consulte aquí (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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