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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Other: Sham Procedure; Drug: Ranibizumab; Drug: Vamikibart

• Study Type: Interventional
• Enrollment (Actual): 394
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: BP43445 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Capital Federal, Argentina, C1015ABO
    • Centro Oftalmológico Dr. Charles S.A.
  • Capital Federal, Argentina, C1120AAN
    • Oftalmos
  • Ciudad Autonoma Buenos Aires, Argentina, C1061AAE
    • Buenos Aires Mácula
  • Cordoba, Argentina, X5200ANS
    • Centro Privado de Ojos Romagosa
  • Lomas de Zamora, Argentina, B1888FRB
    • Centro de ojos Loria
  • Mendoza, Argentina, M5500GGK
    • Oftar
  • Rosario, Argentina, S2000CTC
    • Microcirugía Ocular S.A
  • Rosario, Argentina, S2000DLA
    • Grupo Laser Vision
  • San Nicolás, Argentina, C1015ABO
    • Organizacion Medica de Investigacion
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K2B 7E9
      • The Retina Centre of Ottawa
    • Toronto, Ontario, Canada, M3C 0G9
      • Toronto Retina Institute
  • Quebec
    • Boisbriand, Quebec, Canada, J7H 0E8
      • Institut De L'oeil Des Laurentides
• Czechia
  • Ostrava, Czechia, 708 52
    • Faculty Hospital Ostrava; Ophthalmology clinic
  • Prague, Czechia, 100 34
    • Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
  • Prague, Czechia
    • AXON Clinical
  • Prague, Czechia, 128 08
    • General Teaching Hospital Prague; Ophthalmology clinic
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Medical Center
  • Seongnam-si, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 07301
    • Kim's Eye Hospital
• Poland
  • Gda?sk, Poland, 80-402
    • Dobry Wzrok Sp Z O O
  • Gliwice, Poland, 44-100
    • Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
  • Katowice, Poland, 40-514
    • Uniwersyteckie Centrum Kliniczne; UCK im prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
  • Krakow, Poland, 31-070
    • Centrum Medyczne UNO-MED
  • Lublin, Poland, 20-079
    • SPSK nr 1 w Lublinie; Klinika Chirurgii Siatkowki i Ciala Szklistego
  • Olsztyn, Poland, 10-424
    • Centrum Diagnostyki i Mikrochirurgii Oka LENS
  • Rybnik, Poland, 44-203
    • LensClinic
  • Tarnowskie Góry, Poland, 42-600
    • Caminomed
• Puerto Rico
  • Arecibo, Puerto Rico, 00612
    • Emanuelli Research and Development Center LLC
• Spain
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet; Servicio de Oftalmologia
  • Barcelona
    • Sant Cugat De Valles, Barcelona, Spain, 08190
      • Hospital General de Catalunya; Servicio de oftalmologia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro; Servicio de oftalmologia
  • Valencia
    • Burjassot, Valencia, Spain, 46100
      • Oftalvist Valencia
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Bradford Royal Infirmary
  • Bristol, United Kingdom, BS1 2LX
    • Bristol Eye Hospital
  • Gloucestershire, United Kingdom, GL1 3NN
    • Gloucestershire Hospitals NHS Foundation Trust
  • Guildford, United Kingdom, GU2 7XX
    • Royal Surrey County Hospital
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital NHS Foundation Trust
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
• United States
  • California
    • Arcadia, California, United States, 91006
      • Win Retina
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Poway, California, United States, 92064
      • Retina Consultants, San Diego
    • Sacramento, California, United States, 95825
      • Retinal Consultants Med Group
    • Torrance, California, United States, 90502
      • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Walnut Creek, California, United States, 94598
      • Bay Area Retina Associates
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Retina Associates, PC
  • District of Columbia
    • Washington, District of Columbia, United States, 20011-3010
      • Emerson Clinical Research Institute LLC
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye
    • Fort Lauderdale, Florida, United States, 33309
      • Pinnacle Research Institute
    • Fort Myers, Florida, United States, 33912
      • National Ophthalmic Research Institute
    • Miami, Florida, United States, 33126-5690
      • Retina Macula Specialists of Miami - LeJeune Road Office
    • Orlando, Florida, United States, 32806-1101
      • Florida Retina Institute
    • Saint Petersburg, Florida, United States, 33711-1141
      • Retina Vitreous Associates of Florida
    • Wesley Chapel, Florida, United States, 33544
      • Retina Specialists of Tampa
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Butchertown Clinical Trials
  • Maryland
    • Hagerstown, Maryland, United States, 21740-5940
      • Cumberland Valley Retina Consultants
  • Massachusetts
    • Lawrence, Massachusetts, United States, 01843
      • Tallman Eye Associates
  • Mississippi
    • Southaven, Mississippi, United States, 38671
      • Deep Blue Retina PLLC
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New York
    • Lynbrook, New York, United States, 11563
      • Opthalmic Consultants of LI
    • Orchard Park, New York, United States, 14127
      • Buffalo Niagara Retina Associates
    • Rochester, New York, United States, 14620
      • Retina Associates of Western New York
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Western Carolina Retinal Associate PA
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Meridian Clinical Research
    • Cleveland, Ohio, United States, 44915
      • Cleveland Clinic Foundation
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Verum Research LLC
    • Portland, Oregon, United States, 97225
      • EyeHealth Northwest
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Erie Retinal Surgery
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists, PC
    • Sewickley, Pennsylvania, United States, 15143
      • Sewickley Eye Group
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Institute
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Eye Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Retina Consultants of Nashville
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Retina Associates
    • Austin, Texas, United States, 78750
      • Austin Clinical Research LLC
    • Harlingen, Texas, United States, 78550
      • Valley Retina Institute P.A.
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates
    • The Woodlands, Texas, United States, 77384-4167
      • Retina Consultants of Texas
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group, LLC
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center
    • Norfolk, Virginia, United States, 23502
      • Wagner Kapoor Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm D: 0.5 mg Ranibizumab Q4W; 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.	Drug: Ranibizumab; Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.; Other Names: Lucentis
Experimental: Arm A: 0.25 mg Vamikibart Q8W; 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.	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.; Drug: Vamikibart; Vamikibart will be administered by IVT injection as specified in each treatment arm.; Other Names: RO7200220
Experimental: Arm B: 1.0 mg Vamikibart Q8W; 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.	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.; Drug: Vamikibart; Vamikibart will be administered by IVT injection as specified in each treatment arm.; Other Names: RO7200220
Experimental: Arm C: 1.0 mg Vamikibart Q4W; 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.	Drug: Vamikibart; Vamikibart will be administered by IVT injection as specified in each treatment arm.; Other Names: RO7200220

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number of Participants With Systemic and Ocular Adverse Events (AEs)	Up to Week 72
Number of Participants With Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters	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 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
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 20 and Week 24, in Previously Treated Participants	Baseline, Week 20 and Week 24
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
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 Averaged Over Week 32 and Week 36, in Overall Enrolled Population	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 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)
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)
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)
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
Change From Baseline in CST at Week 36	Baseline, Week 36
Change From Baseline in CST at Week 24	Baseline, Week 24
Change From Baseline in CST Over Time	From baseline up to end of study (up to Week 72)
Percentage of Participants With Absence of Diabetic Macular Edema (DME) Over Time	From baseline up to end of study (up to Week 72)
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)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2021
• Primary Completion (Estimated): October 3, 2024
• Study Completion (Estimated): April 17, 2025

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: BP43445; 2021-003756-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org/). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No