Clinical trial NCT05151744: A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab 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 in Combination With Ranibizumab 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: 187
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 BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 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: Mean Change from Baseline in BCVA Over Time
timeFrame: From baseline to end of study (up to Week 72)
measure: Percentage of Participants Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time
timeFrame: From baseline to end of study (up to Week 72)
measure: Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time
timeFrame: From baseline to end of study (up to Week 72)
measure: Percentage of of Participants with BCVA ≥ 69 Letters (20/40 Snellen Equivalent) or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time
timeFrame: From baseline to end of study (up to Week 72)
measure: Percentage of Participants with BCVA ≤38 Letters (20/200 Snellen Equivalent) Over Time
timeFrame: From baseline 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: Mean Change from Baseline in CST Over Time
timeFrame: From baseline to end of study (up to Week 72)
measure: Percentage of Participants with Absence of Diabetic Macular Edema Over Time
timeFrame: From baseline to end of study (up to Week 72)
measure: Number of Participants with Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time
timeFrame: From baseline to end of study (up to Week 72)
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Win Retina
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Tampa
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Southaven
country: United States
facility: Deep Blue Retina PLLC
state: Mississippi
city: Eugene
country: United States
facility: Verum Research LLC
state: Oregon
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
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: 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: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah MC
city: Petach Tikva
country: Israel
facility: Rabin MC
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky MC
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
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: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
city: Krakow
country: Poland
facility: Centrum Medyczne UNO-MED
city: Olsztyn
country: Poland
facility: Centrum Diagnostyki i Mikrochirurgii Oka LENS
city: Tarnowskie Góry
country: Poland
facility: Caminomed
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research and Development Center LLC
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Clinica Universitaria de Navarra
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: Kings College Hospital NHS Foundation Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: