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

NCT05151744 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: BP434642021-004390-31
• Study Type: interventional
• Target: 187
• Locations: 9 countries
• Sites: 38

Brief 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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48 in Treatment-naïve Participants

  BCVA was measured via Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters using a set of three Precision vision\^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity (VA) examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a Mixed Model for Repeated Measurements (MMRM) model.

  Baseline, Week 44 and Week 48

Secondary Outcomes (28)

• Number of Participants With Systemic and Ocular Adverse Events (AEs)

  Up to Week 72

• Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Previously Treated Participants

  Baseline, Week 44 and Week 48

• Change From Baseline in BCVA Averaged Over Week 44 and Week 48 in Overall ITT Population

  Baseline, Week 44 and Week 48

• Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants

  Baseline, Week 32 and Week 36

• Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants

  Baseline, Week 32 and Week 36

Study Arms (2)

Arm A: Vamikibart + Ranibizumab

EXPERIMENTAL

Participants will receive vamikibart, 1 milligram (mg) administered as intravitreal (IVT) injection in combination with ranibizumab, 0.5 mg IVT, on Day 1 and every fourth week (Q4W) up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.

Drug: Vamikibart; Drug: Ranibizumab

Arm B: Ranibizumab

ACTIVE COMPARATOR

Participants will receive ranibizumab, 0.5 mg IVT, from Day 1 and Q4W in combination with sham up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.

Drug: Ranibizumab; Other: Sham Procedure

Interventions

Vamikibart DRUG

Vamikibart will be administered by IVT injection in the study eye.

Also known as: RO7200220

Arm A: Vamikibart + Ranibizumab

Ranibizumab DRUG

Ranibizumab will be administered by IVT injection in the study eye.

Also known as: Lucentis

Arm A: Vamikibart + Ranibizumab; Arm B: Ranibizumab

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.

Arm B: Ranibizumab

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 (38)

Win Retina

Arcadia, California, 91006, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Florida Eye Associates

Melbourne, Florida, 30394-7344, United States

Location

Retina Vitreous Associates of Florida

Tampa, Florida, 33617, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Deep Blue Retina PLLC

Southaven, Mississippi, 38671, United States

Location

Verum Research LLC

Eugene, Oregon, 97401, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Organizacion Medica de Investigacion

Buenos Aires, C1015ABO, Argentina

Location

Centro Oftalmológico 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

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

Rambam Medical Center

Haifa, 3109601, Israel

Location

Hadassah MC

Jerusalem, 9112001, Israel

Location

Rabin MC

Petah Tikva, 4941492, Israel

Location

Kaplan Medical Center

Rehovot, 7660101, Israel

Location

Tel Aviv Sourasky MC

Tel Aviv, 6423906, Israel

Location

Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA

Gliwice, 44-100, Poland

Location

Centrum Medyczne UNO-MED

Krakow, 31-070, Poland

Location

Centrum Diagnostyki i Mikrochirurgii Oka LENS

Olsztyn, 10-424, Poland

Location

Caminomed

Tarnowskie Góry, 42-600, Poland

Location

Emanuelli Research and Development Center LLC

Arecibo, 00613, Puerto Rico

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, 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

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Clinica Universitaria de Navarra

Madrid, 28027, Spain

Location

Gloucestershire Hospitals NHS Foundation Trust

Gloucestershire, GL1 3NN, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, 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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 17, 2021
• Primary Completion: April 17, 2024
• Study Completion: October 1, 2024
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (2); KR (5); IL (5); US (10); CA (3); PR (1); AR (5); PL (4); GB (3)