A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema
- Interventions
- Registration Number
- NCT05151744
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
- 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: Ranibizumab Sham Procedure Participants will receive ranibizumab, 0.5 mg IVT, from Day 1 and Q4W in combination with sham up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72. Arm A: Vamikibart + Ranibizumab Vamikibart Participants will receive vamikibart, 1 milligram (mg) administered as intravitreal (IVT) injection in combination with ranibizumab, 0.5 mg IVT, on Day 1 and every fourth week (Q4W) up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72. Arm A: Vamikibart + Ranibizumab Ranibizumab Participants will receive vamikibart, 1 milligram (mg) administered as intravitreal (IVT) injection in combination with ranibizumab, 0.5 mg IVT, on Day 1 and every fourth week (Q4W) up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72. Arm B: Ranibizumab Ranibizumab Participants will receive ranibizumab, 0.5 mg IVT, from Day 1 and Q4W in combination with sham up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.
- 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 Percentage of Participants with Absence of Diabetic Macular Edema Over Time From baseline to end of study (up to Week 72) Number of Participants with Systemic and Ocular Adverse Events (AEs) Up to Week 72 Number of Participants with Abnormalities in Standard Ophthalmological Assessments Up to Week 72 Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants Baseline, Week 32 and Week 36 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 of Participants with BCVA ≥ 69 Letters (20/40 Snellen Equivalent) or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time From baseline to end of study (up to Week 72) Percentage of Participants with BCVA ≤38 Letters (20/200 Snellen Equivalent) Over Time From baseline to end of study (up to Week 72) Change from Baseline in CST at Week 36 Baseline, Week 36 Number of Participants with Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time From baseline to end of study (up to Week 72) 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 Mean Change from Baseline in BCVA Over Time From baseline to end of study (up to Week 72) Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time From baseline to end of study (up to Week 72) Mean Change from Baseline in CST Over Time From baseline to end of study (up to Week 72) Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population Baseline, Week 44 and Week 48 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 Gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA Over Time From baseline to end of study (up to Week 72) Change from Baseline in Central Subfield Thickness (CST) at Week 48 Baseline, Week 48 Change from Baseline in CST at Week 24 Baseline, Week 24 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 44 and Week 48, in Previously Treated Participants Baseline, Week 44 and Week 48 Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population Baseline, Week 20 and Week 24
Trial Locations
- Locations (36)
Retina Institute of Ottawa
🇨🇦Ottawa, Ontario, Canada
Win Retina
🇺🇸Arcadia, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
Florida Eye Associates
🇺🇸Melbourne, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Tampa, Florida, United States
Deep Blue Retina PLLC
🇺🇸Southaven, Mississippi, United States
Verum Research LLC
🇺🇸Eugene, Oregon, United States
Texas Retina Associates
🇺🇸Arlington, Texas, United States
Retina Consultants of Texas
🇺🇸Bellaire, Texas, 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
Grupo Laser Vision
🇦🇷Rosario, Argentina
Toronto Retina Institute
🇨🇦Toronto, Ontario, Canada
Institut De L'Oeil Des Laurentides
🇨🇦Boisbriand, Quebec, Canada
Rambam Medical Center
🇮🇱Haifa, Israel
Hadassah MC
🇮🇱Jerusalem, Israel
Rabin MC
🇮🇱Petach Tikva, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
Tel Aviv Sourasky MC
🇮🇱Tel Aviv, Israel
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, 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
Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
🇵🇱Gliwice, Poland
Centrum Medyczne UNO-MED
🇵🇱Krakow, Poland
Centrum Diagnostyki i Mikrochirurgii Oka LENS
🇵🇱Olsztyn, Poland
Caminomed
🇵🇱Tarnowskie Góry, Poland
Emanuelli Research and Development Center LLC
🇵🇷Arecibo, Puerto Rico
Clinica Universitaria de Navarra
🇪🇸Madrid, Spain
Gloucestershire Hospitals NHS Foundation Trust
🇬🇧Gloucestershire, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Kings College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom