Clinical trial NCT05151731: A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema
Official title: A Phase II, Multicenter, Randomized, Double Masked, Active Comparator-Controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2021-12-09
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes mellitus (Type 1 or Type 2)
* Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula
* Decreased visual acuity attributable primarily to DME
* Ability and willingness to provide written informed consent and to comply with the study protocol
* Willingness to allow Aqueous Humor collection
* For women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of \<1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment

Exclusion Criteria:

* Hemoglobin A1c (HbA1c) of greater than (\>) 12%
* Uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmHg) and/or a diastolic value \>100 mmHg while a patient is at rest
* Currently pregnant or breastfeeding, or intend to become pregnant during the study
* Prior treatment with panretinal photocoagulation or macular laser to the study eye
* Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye
* Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye
* Prior or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1 to the study eye; Vabysmo\^TM within 16 weeks prior to Day 1, prior Beovu® is not permitted
* Prior administration of IVT brolucizumab (Beovu®): ever; vamikibart: \</=24 weeks prior to Day 1) in either eye
* Any proliferative diabetic retinopathy
* Active intraocular or periocular infection or active intraocular inflammation in the study eye
* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
* Other protocol-specified inclusion/exclusion criteria may apply

Primary outcomes:
measure: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
timeFrame: Baseline, Week 44 and Week 48
Secondary outcomes:
measure: Number of Participants With Systemic and Ocular Adverse Events (AEs)
timeFrame: Up to Week 72
measure: Number of Participants With Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters
timeFrame: Up to Week 72
measure: Number of Participants With Abnormalities in Standard Ophthalmological Assessments
timeFrame: Up to Week 72
measure: Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants
timeFrame: Baseline, Week 44 and Week 48
measure: Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population
timeFrame: Baseline, Week 44 and Week 48
measure: Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants
timeFrame: Baseline, Week 20 and Week 24
measure: Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants
timeFrame: Baseline, Week 20 and Week 24
measure: Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population
timeFrame: Baseline, Week 20 and Week 24
measure: Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
timeFrame: Baseline, Week 32 and Week 36
measure: Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
timeFrame: Baseline, Week 32 and Week 36
measure: Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population
timeFrame: Baseline, Week 32 and Week 36
measure: Change From Baseline in BCVA Over Time
timeFrame: From baseline up to end of study (up to Week 72)
measure: Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time
timeFrame: From baseline up to end of study (up to Week 72)
measure: Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time
timeFrame: From baseline up to end of study (up to Week 72)
measure: Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent), or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time
timeFrame: From baseline up to end of study (up to Week 72)
measure: Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time
timeFrame: From baseline up to end of study (up to Week 72)
measure: Change From Baseline in Central Subfield Thickness (CST) at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in CST at Week 36
timeFrame: Baseline, Week 36
measure: Change From Baseline in CST at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in CST Over Time
timeFrame: From baseline up to end of study (up to Week 72)
measure: Percentage of Participants With Absence of Diabetic Macular Edema (DME) Over Time
timeFrame: From baseline up to end of study (up to Week 72)
measure: Percentage of Participants With Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time
timeFrame: From baseline up to end of study (up to Week 72)
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Win Retina
state: California
city: Poway
country: United States
facility: Retina Consultants, San Diego
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Med Group
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Lakewood
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Washington
country: United States
facility: Emerson Clinical Research Institute LLC
state: District of Columbia
city: Deerfield Beach
country: United States
facility: Rand Eye
state: Florida
city: Wesley Chapel
country: United States
facility: Retina Specialists of Tampa
state: Florida
city: Louisville
country: United States
facility: Butchertown Clinical Trials
state: Kentucky
city: Hagerstown
country: United States
facility: Cumberland Valley Retina PC
state: Maryland
city: Southaven
country: United States
facility: Deep Blue Retina PLLC
state: Mississippi
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Lynbrook
country: United States
facility: Opthalmic Consultants of LI
state: New York
city: Rochester
country: United States
facility: University of Rochester Flaum Eye Institute
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associate PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Meridian Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Eugene
country: United States
facility: Verum Research LLC
state: Oregon
city: Portland
country: United States
facility: EyeHealth Northwest
state: Oregon
city: Erie
country: United States
facility: Erie Retinal Surgery
state: Pennsylvania
city: Kingston
country: United States
facility: Eye Care Specialists, PC
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Eye Institute
state: South Dakota
city: Nashville
country: United States
facility: Retina Consultants of Nashville
state: Tennessee
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research LLC
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute P.A.
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Norfolk
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
city: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion
city: Capital Federal
country: Argentina
facility: Centro Oftalmológico Dr. Charles S.A.
city: Capital Federal
country: Argentina
facility: Oftalmos
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Buenos Aires Mácula
city: Cordoba
country: Argentina
facility: Centro Privado de Ojos Romagosa
city: Lomas de Zamora
country: Argentina
facility: Centro de ojos Loria
city: Mendoza
country: Argentina
facility: Oftar
city: Rosario
country: Argentina
facility: Microcirugía Ocular S.A
city: Rosario
country: Argentina
facility: Grupo Laser Vision
city: Ottawa
country: Canada
facility: Retina Institute of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Toronto Retina Institute
state: Ontario
city: Boisbriand
country: Canada
facility: Institut De L'Oeil Des Laurentides
state: Quebec
city: Ostrava
country: Czechia
facility: Faculty Hospital Ostrava
city: Prague
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
city: Prague
country: Czechia
facility: General Teaching Hospital Prague
city: Prague
country: Czechia
facility: AXON Clinical
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital
city: Gliwice
country: Poland
facility: Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Centrum Medyczne UNO-MED
city: Lublin
country: Poland
facility: SPSK nr 1 w Lublinie
city: Olsztyn
country: Poland
facility: Centrum Diagnostyki i Mikrochirurgii Oka LENS
city: Rybnik
country: Poland
facility: LensClinic
city: Tarnowskie Góry
country: Poland
facility: Caminomed
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research and Development Center LLC
city: Sant Cugat De Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Burjassot
country: Spain
facility: Oftalvist Valencia
state: Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: Gloucestershire
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: