A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema
- Interventions
- Registration Number
- NCT05151731
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 394
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: 1.0 mg Vamikibart Q8W Sham Procedure Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms. Arm C: 1.0 mg Vamikibart Q4W Vamikibart Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections. Arm A: 0.25 mg Vamikibart Q8W Sham Procedure Participants will receive vamikibart 0.25 milligrams (mg), by intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms. Arm B: 1.0 mg Vamikibart Q8W Vamikibart Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms. Arm A: 0.25 mg Vamikibart Q8W Vamikibart Participants will receive vamikibart 0.25 milligrams (mg), by intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms. Arm D: 0.5 mg Ranibizumab Q4W Ranibizumab Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants Baseline, Week 44 and Week 48
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants Baseline, Week 20 and Week 24 Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants Baseline, Week 32 and Week 36 Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time From baseline up to end of study (up to Week 72) Number of Participants With Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters Up to Week 72 Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants Baseline, Week 20 and Week 24 Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time From baseline up to end of study (up to Week 72) Change From Baseline in Central Subfield Thickness (CST) at Week 48 Baseline, Week 48 Number of Participants With Abnormalities in Standard Ophthalmological Assessments Up to Week 72 Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants Baseline, Week 44 and Week 48 Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population Baseline, Week 44 and Week 48 Change From Baseline in CST at Week 36 Baseline, Week 36 Percentage of Participants With Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time From baseline up to end of study (up to Week 72) Number of Participants With Systemic and Ocular Adverse Events (AEs) Up to Week 72 Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population Baseline, Week 20 and Week 24 Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants Baseline, Week 32 and Week 36 Change From Baseline in BCVA Over Time From baseline up to end of study (up to Week 72) Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent), or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time From baseline up to end of study (up to Week 72) Change From Baseline in CST at Week 24 Baseline, Week 24 Percentage of Participants With Absence of Diabetic Macular Edema (DME) Over Time From baseline up to end of study (up to Week 72) Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population Baseline, Week 32 and Week 36 Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time From baseline up to end of study (up to Week 72) Change From Baseline in CST Over Time From baseline up to end of study (up to Week 72)
Trial Locations
- Locations (70)
Centro de ojos Loria
🇦🇷Lomas de Zamora, Argentina
Oftar
🇦🇷Mendoza, Argentina
Microcirugía Ocular S.A
🇦🇷Rosario, Argentina
Grupo Laser Vision
🇦🇷Rosario, Argentina
Retina Institute of Ottawa
🇨🇦Ottawa, Ontario, Canada
Toronto Retina Institute
🇨🇦Toronto, Ontario, Canada
Institut De L'Oeil Des Laurentides
🇨🇦Boisbriand, Quebec, Canada
Faculty Hospital Ostrava
🇨🇿Ostrava, Czechia
Faculty Hospital Kralovske Vinohrady
🇨🇿Prague, Czechia
General Teaching Hospital Prague
🇨🇿Prague, Czechia
AXON Clinical
🇨🇿Prague, Czechia
LensClinic
🇵🇱Rybnik, Poland
Caminomed
🇵🇱Tarnowskie Góry, Poland
Bristol Eye Hospital
🇬🇧Bristol, United Kingdom
Win Retina
🇺🇸Arcadia, California, United States
Retina Consultants, San Diego
🇺🇸Poway, California, United States
Retinal Consultants Med Group
🇺🇸Sacramento, California, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
Colorado Retina Associates, PC
🇺🇸Lakewood, Colorado, United States
Emerson Clinical Research Institute LLC
🇺🇸Washington, District of Columbia, United States
Rand Eye
🇺🇸Deerfield Beach, Florida, United States
Retina Specialists of Tampa
🇺🇸Wesley Chapel, Florida, United States
Butchertown Clinical Trials
🇺🇸Louisville, Kentucky, United States
Cumberland Valley Retina PC
🇺🇸Hagerstown, Maryland, United States
Deep Blue Retina PLLC
🇺🇸Southaven, Mississippi, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Opthalmic Consultants of LI
🇺🇸Lynbrook, New York, United States
University of Rochester Flaum Eye Institute
🇺🇸Rochester, New York, United States
Western Carolina Retinal Associate PA
🇺🇸Asheville, North Carolina, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Meridian Clinical Research
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Verum Research LLC
🇺🇸Eugene, Oregon, United States
EyeHealth Northwest
🇺🇸Portland, Oregon, United States
Erie Retinal Surgery
🇺🇸Erie, Pennsylvania, United States
Eye Care Specialists, PC
🇺🇸Kingston, Pennsylvania, United States
Charleston Neuroscience Institute
🇺🇸Ladson, South Carolina, United States
Black Hills Eye Institute
🇺🇸Rapid City, South Dakota, United States
Retina Consultants of Nashville
🇺🇸Nashville, Tennessee, United States
Texas Retina Associates
🇺🇸Arlington, Texas, United States
Austin Clinical Research LLC
🇺🇸Austin, Texas, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Valley Retina Institute P.A.
🇺🇸McAllen, Texas, United States
Strategic Clinical Research Group, LLC
🇺🇸Willow Park, Texas, United States
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States
Wagner Macula & Retina Center
🇺🇸Norfolk, Virginia, United States
Organizacion Medica de Investigacion
🇦🇷Buenos Aires, Argentina
Centro Oftalmológico Dr. Charles S.A.
🇦🇷Capital Federal, Argentina
Oftalmos
🇦🇷Capital Federal, Argentina
Buenos Aires Mácula
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Centro Privado de Ojos Romagosa
🇦🇷Cordoba, Argentina
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Kim's Eye Hospital
🇰🇷Seoul, Korea, Republic of
Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
🇵🇱Gliwice, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Katowice, Poland
Centrum Medyczne UNO-MED
🇵🇱Krakow, Poland
SPSK nr 1 w Lublinie
🇵🇱Lublin, Poland
Centrum Diagnostyki i Mikrochirurgii Oka LENS
🇵🇱Olsztyn, Poland
Emanuelli Research and Development Center LLC
🇵🇷Arecibo, Puerto Rico
Hospital General de Catalunya
🇪🇸Sant Cugat De Valles, Barcelona, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Oftalvist Valencia
🇪🇸Burjassot, Valencia, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Gloucestershire Hospitals NHS Foundation Trust
🇬🇧Gloucestershire, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, United Kingdom