A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

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

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
• Start date: December 17, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• 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 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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

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)