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

NCT05151731 | Completed Phase 2 FDA Drug

• 2 other identifiers: BP434452021-003756-16
• Study Type: interventional
• Target: 394
• Locations: 9 countries
• Sites: 74

Brief 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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• 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

Study Arms (4)

Arm A: 0.25 mg Vamikibart Q8W

EXPERIMENTAL

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.

Drug: Vamikibart; Other: Sham Procedure

Arm B: 1.0 mg Vamikibart Q8W

EXPERIMENTAL

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.

Drug: Vamikibart; Other: Sham Procedure

Arm C: 1.0 mg Vamikibart Q4W

EXPERIMENTAL

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

Arm D: 0.5 mg Ranibizumab Q4W

ACTIVE COMPARATOR

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

Interventions

Vamikibart DRUG

Vamikibart will be administered by IVT injection as specified in each treatment arm.

Also known as: RO7200220

Arm A: 0.25 mg Vamikibart Q8W; Arm B: 1.0 mg Vamikibart Q8W; Arm C: 1.0 mg Vamikibart Q4W

Ranibizumab DRUG

Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.

Also known as: Lucentis

Arm D: 0.5 mg Ranibizumab Q4W

Sham Procedure OTHER

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.

Arm A: 0.25 mg Vamikibart Q8W; Arm B: 1.0 mg Vamikibart Q8W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (74)

Win Retina

Arcadia, California, 91006, United States

Location

Retina Consultants, San Diego

Poway, California, 92064, United States

Location

Retinal Consultants Med Group

Sacramento, California, 95825, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Colorado Retina Associates, PC

Lakewood, Colorado, 80228, United States

Location

Emerson Clinical Research Institute LLC

Washington D.C., District of Columbia, 20011-3010, United States

Location

Rand Eye

Deerfield Beach, Florida, 33064, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Florida Retina Institute

Orlando, Florida, 32806-1101, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33607, United States

Location

Retina Specialists of Tampa

Wesley Chapel, Florida, 33544, United States

Location

Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Cumberland Valley Retina PC

Hagerstown, Maryland, 21740, United States

Location

Deep Blue Retina PLLC

Southaven, Mississippi, 38671, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Opthalmic Consultants of LI

Lynbrook, New York, 11563, United States

Location

University of Rochester Flaum Eye Institute

Rochester, New York, 14642, United States

Location

Western Carolina Retinal Associate PA

Asheville, North Carolina, 28803, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Meridian Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Verum Research LLC

Eugene, Oregon, 97401, United States

Location

EyeHealth Northwest

Portland, Oregon, 97225, United States

Location

Erie Retinal Surgery

Erie, Pennsylvania, 16507, United States

Location

Eye Care Specialists, PC

Kingston, Pennsylvania, 18704, United States

Location

Sewickley Eye Group

Sewickley, Pennsylvania, 15143, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

Location

Black Hills Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Retina Consultants of Nashville

Nashville, Tennessee, 37203, United States

Location

Texas Retina Associates

Arlington, Texas, 75075, United States

Location

Austin Clinical Research LLC

Austin, Texas, 78750, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Valley Retina Institute P.A.

McAllen, Texas, 78503, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 78240, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Wagner Macula & Retina Center

Norfolk, Virginia, 23502, United States

Location

Organizacion Medica de Investigacion

Buenos Aires, C1015ABO, Argentina

Location

Centro Oftalmologico Dr. Charles S.A.

Capital Federal, C1116, Argentina

Location

Oftalmos

Capital Federal, C1120AAN, Argentina

Location

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, C1061AAE, Argentina

Location

Centro Privado de Ojos Romagosa

Córdoba, Argentina

Location

Centro de ojos Loria

Lomas de Zamora, Argentina

Location

Oftar

Mendoza, M5500GGK, Argentina

Location

Microcirugía Ocular S.A

Rosario, S2000CTC, Argentina

Location

Grupo Laser Vision

Rosario, S2000DLA, Argentina

Location

Retina Institute of Ottawa

Ottawa, Ontario, K2B 7E9, Canada

Location

Toronto Retina Institute

Toronto, Ontario, M3C 0G9, Canada

Location

Institut De L'Oeil Des Laurentides

Boisbriand, Quebec, J7H 0E8, Canada

Location

Faculty Hospital Ostrava

Ostrava, 708 52, Czechia

Location

Faculty Hospital Kralovske Vinohrady

Prague, 100 34, Czechia

Location

General Teaching Hospital Prague

Prague, 128 08, Czechia

Location

AXON Clinical

Prague, Czechia

Location

Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA

Gliwice, 44-100, Poland

Location

Uniwersyteckie Centrum Kliniczne

Katowice, 40-514, Poland

Location

Centrum Medyczne UNO-MED

Krakow, 31-070, Poland

Location

SPSK nr 1 w Lublinie

Lublin, 20-079, Poland

Location

Centrum Diagnostyki i Mikrochirurgii Oka LENS

Olsztyn, 10-424, Poland

Location

LensClinic

Rybnik, 44-203, Poland

Location

Caminomed

Tarnowskie Góry, 42-600, Poland

Location

Emanuelli Research and Development Center LLC

Arecibo, 00612, Puerto Rico

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13605, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Kim's Eye Hospital

Seoul, 07301, South Korea

Location

Hospital General de Catalunya

Sant Cugat de Valles, Barcelona, 08190, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Oftalvist Valencia

Burjassot, Valencia, 46100, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Bristol Eye Hospital

Bristol, BS1 2LX, United Kingdom

Location

Gloucestershire Hospitals NHS Foundation Trust

Gloucestershire, GL1 3NN, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 9, 2021
• Study Start: December 31, 2021
• Primary Completion: November 6, 2024
• Study Completion: April 21, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

AR (9); CZ (4); PR (1); PL (7); KR (5); CA (3); US (36); ES (4); GB (5)