A Study to Investigate Vamikibart (RO7200220) 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 Administered Intravitreally in Patients With Diabetic Macular Edema

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05151731
• Other study ID #: BP43445
• Secondary ID: 2021-003756-16
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 31, 2021
• Est. completion date: April 17, 2025

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 394
• Est. completion date: April 17, 2025
• Est. primary completion date: October 3, 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 as specified in each treatment arm.
• Ranibizumab
Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.

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. Sham procedure will be administered to participants in the Q8W arms at applicable visits to maintain masking between treatment arms.

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	Centro Privado de Ojos Romagosa	Cordoba
Argentina	Centro de ojos Loria	Lomas de Zamora
Argentina	Oftar	Mendoza
Argentina	Grupo Laser Vision	Rosario
Argentina	Microcirugía Ocular S.A	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
Czechia	Faculty Hospital Ostrava; Ophthalmology clinic	Ostrava
Czechia	AXON Clinical	Prague
Czechia	Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic	Prague
Czechia	General Teaching Hospital Prague; Ophthalmology clinic	Prague
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	SPSK nr 1 w Lublinie; Klinika Chirurgii Siatkowki i Ciala Szklistego	Lublin
Poland	Centrum Diagnostyki i Mikrochirurgii Oka LENS	Olsztyn
Poland	LensClinic	Rybnik
Poland	Caminomed	Tarnowskie Góry
Puerto Rico	Emanuelli Research and Development Center LLC	Arecibo
Spain	Oftalvist Valencia	Burjassot	Valencia
Spain	Hospital Universitario Puerta de Hierro; Servicio de oftalmologia	Majadahonda	Madrid
Spain	Hospital General de Catalunya; Servicio de oftalmologia	Sant Cugat De Valles	Barcelona
Spain	Hospital Universitario Miguel Servet; Servicio de Oftalmologia	Zaragoza
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Bristol Eye Hospital	Bristol
United Kingdom	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 States	Win Retina	Arcadia	California
United States	Texas Retina Associates	Arlington	Texas
United States	Western Carolina Retinal Associate PA	Asheville	North Carolina
United States	Austin Clinical Research LLC	Austin	Texas
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Meridian Clinical Research	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Rand Eye	Deerfield Beach	Florida
United States	Erie Retinal Surgery	Erie	Pennsylvania
United States	Verum Research LLC	Eugene	Oregon
United States	Pinnacle Research Institute	Fort Lauderdale	Florida
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Valley Retina Institute P.A.	Harlingen	Texas
United States	Eye Care Specialists, PC	Kingston	Pennsylvania
United States	Charleston Neuroscience Institute	Ladson	South Carolina
United States	Colorado Retina Associates, PC	Lakewood	Colorado
United States	Tallman Eye Associates	Lawrence	Massachusetts
United States	Butchertown Clinical Trials	Louisville	Kentucky
United States	Opthalmic Consultants of LI	Lynbrook	New York
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Retina Macula Specialists of Miami - LeJeune Road Office	Miami	Florida
United States	Retina Consultants of Nashville	Nashville	Tennessee
United States	Wagner Kapoor Institute	Norfolk	Virginia
United States	Buffalo Niagara Retina Associates	Orchard Park	New York
United States	Florida Retina Institute	Orlando	Florida
United States	EyeHealth Northwest	Portland	Oregon
United States	Retina Consultants, San Diego	Poway	California
United States	Black Hills Eye Institute	Rapid City	South Dakota
United States	Sierra Eye Associates	Reno	Nevada
United States	Retina Associates of Western New York	Rochester	New York
United States	Retinal Consultants Med Group	Sacramento	California
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Sewickley Eye Group	Sewickley	Pennsylvania
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
United States	Emerson Clinical Research Institute LLC	Washington	District of Columbia
United States	Retina Specialists of Tampa	Wesley Chapel	Florida
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Czechia,  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	Change From Baseline in BCVA Over Time		From baseline up to end of study (up to Week 72)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
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	Change From Baseline in CST Over Time		From baseline up to end of study (up to Week 72)
Secondary	Percentage of Participants With Absence of Diabetic Macular Edema (DME) Over Time		From baseline up to end of study (up to Week 72)
Secondary	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)