Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05151744
Other study ID # BP43464
Secondary ID 2021-004390-31
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 17, 2021
Est. completion date October 1, 2024

Study information

Verified date June 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 187
Est. completion date October 1, 2024
Est. primary completion date April 17, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 BeovuĀ® is not permitted - Prior administration of IVT brolucizumab (BeovuĀ®): 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


Related Conditions & MeSH terms


Intervention

Drug:
Vamikibart
Vamikibart will be administered by IVT injection in the study eye.
Ranibizumab
Ranibizumab will be administered by IVT injection in the study eye.
Other:
Sham Procedure
Sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye.

Locations

Country Name City State
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 Organizacion Medica de Investigacion San Nicolás
Canada Institut De L'Oeil Des Laurentides Boisbriand Quebec
Canada The Retina Centre of Ottawa Ottawa Ontario
Canada Toronto Retina Institute Toronto Ontario
Israel Rambam Medical Center; Opthalmology Haifa
Israel Hadassah MC; Ophtalmology Jerusalem
Israel Rabin MC; Ophtalmology Petach Tikva
Israel Kaplan Medical Center; Ophtalmology Rehovot
Israel Tel Aviv Sourasky MC; Ophtalmology Tel Aviv
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of 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 Kim's Eye Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Poland Dobry Wzrok Sp Z O O Gda?sk
Poland Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT Gliwice
Poland Uniwersyteckie Centrum Kliniczne; UCK im prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego Katowice
Poland Centrum Medyczne UNO-MED Krakow
Poland Centrum Diagnostyki i Mikrochirurgii Oka LENS Olsztyn
Poland Caminomed Tarnowskie Góry
Puerto Rico Emanuelli Research and Development Center LLC Arecibo
Spain Clinica Universitaria de Navarra; Servicio de Oftalmologia Madrid
Spain Clinica Universitaria de Navarra; Servicio de Oftalmologia Pamplona Navarra
United Kingdom Gloucestershire Hospitals NHS Foundation Trust Gloucestershire
United Kingdom Royal Surrey County Hospital Guildford
United Kingdom Kings College Hospital NHS Foundation Trust London
United Kingdom Moorfields Eye Hospital NHS Foundation Trust London
United States Win Retina Arcadia California
United States Texas Retina Associates Arlington Texas
United States Verum Research LLC Eugene Oregon
United States Pinnacle Research Institute Fort Lauderdale Florida
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States Florida Eye Associates Melbourne Florida
United States Retina Vitreous Associates of Florida Saint Petersburg Florida
United States Rocky Mountain Retina Salt Lake City Utah
United States Deep Blue Retina PLLC Southaven Mississippi
United States Retina Consultants of Texas The Woodlands Texas
United States Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
United States Bay Area Retina Associates Walnut Creek California

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Israel,  Korea, Republic of,  Poland,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of Participants with Systemic and Ocular Adverse Events (AEs) Up to Week 72
Secondary Number of Participants with Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters Up to Week 72
Secondary Number of Participants with Abnormalities in Standard Ophthalmological Assessments Up to Week 72
Secondary Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants Baseline, Week 44 and Week 48
Secondary Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population Baseline, Week 44 and Week 48
Secondary Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants Baseline, Week 20 and Week 24
Secondary Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants Baseline, Week 20 and Week 24
Secondary Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population Baseline, Week 20 and Week 24
Secondary Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants Baseline, Week 32 and Week 36
Secondary Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants Baseline, Week 32 and Week 36
Secondary Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population Baseline, Week 32 and Week 36
Secondary Mean Change from Baseline in BCVA Over Time From baseline to end of study (up to Week 72)
Secondary Percentage of Participants Gaining = 15, = 10, = 5, or = 0 Letters in BCVA Over Time From baseline to end of study (up to Week 72)
Secondary 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)
Secondary 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)
Secondary Percentage of Participants with BCVA =38 Letters (20/200 Snellen Equivalent) Over Time From baseline to end of study (up to Week 72)
Secondary Change from Baseline in Central Subfield Thickness (CST) at Week 48 Baseline, Week 48
Secondary Change from Baseline in CST at Week 36 Baseline, Week 36
Secondary Change from Baseline in CST at Week 24 Baseline, Week 24
Secondary Mean Change from Baseline in CST Over Time From baseline to end of study (up to Week 72)
Secondary Percentage of Participants with Absence of Diabetic Macular Edema Over Time From baseline to end of study (up to Week 72)
Secondary Number of Participants with Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time From baseline to end of study (up to Week 72)
See also
  Status Clinical Trial Phase
Completed NCT03953807 - A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated Phase 4
Completed NCT03622580 - A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE) Phase 3
Recruiting NCT06262737 - Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Terminated NCT04611152 - A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Terminated NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Active, not recruiting NCT04108156 - This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Withdrawn NCT03629210 - Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema Phase 2
Withdrawn NCT02842541 - Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema Phase 1
Completed NCT02221453 - Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide Phase 2
Completed NCT02979665 - Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
Completed NCT02556723 - Intravitreal Injections of Ziv-aflibercept for Macular Diseases N/A
Completed NCT02000102 - Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab N/A
Completed NCT02088229 - Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema N/A
Terminated NCT00779142 - Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies N/A
Completed NCT01171976 - Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus Phase 3
Completed NCT00989989 - Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema Phase 3
Terminated NCT00768040 - Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema Phase 2
Completed NCT01259609 - Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy N/A
Completed NCT00683176 - Effect of Choline Fenofibrate (SLV348) on Macular Edema Phase 2