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New combo shot aims to save sight in diabetics

NCT ID NCT05151744

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase II trial tested whether adding vamikibart to the standard treatment ranibizumab improves vision more than ranibizumab alone in people with diabetic macular edema. 187 participants received injections into the eye over 76 weeks. The study is complete, and results will show if the combination is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vamikibart (also called RO7200220) combined with ranibizumab (Lucentis)
What this could lead to
If successful, this combination could offer better vision improvement for people with diabetic macular edema than current standard treatment alone.
What could go wrong
This is a Phase II trial, so results are still early. The combination may not prove more effective or could have additional side effects compared to ranibizumab alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

187 people

The number who actually took part.

Started

Dec 2021

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Bay Area Retina Associates

    Walnut Creek, California, 94598, United States

  • Buenos Aires Mácula

    Ciudad Autonoma Buenos Aires, C1061AAE, Argentina

  • Caminomed

    Tarnowskie Góry, 42-600, Poland

  • Centro Oftalmológico Dr. Charles S.A.

    Capital Federal, C1116, Argentina

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    Olsztyn, 10-424, Poland

  • Centrum Medyczne UNO-MED

    Krakow, 31-070, Poland

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinica Universitaria de Navarra

    Madrid, 28027, Spain

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • Deep Blue Retina PLLC

    Southaven, Mississippi, 38671, United States

  • Emanuelli Research and Development Center LLC

    Arecibo, 00613, Puerto Rico

  • Florida Eye Associates

    Melbourne, Florida, 30394-7344, United States

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucestershire, GL1 3NN, United Kingdom

  • Grupo Laser Vision

    Rosario, S2000DLA, Argentina

  • Hadassah MC

    Jerusalem, 9112001, Israel

  • Institut De L'Oeil Des Laurentides

    Boisbriand, Quebec, J7H 0E8, Canada

  • Kaplan Medical Center

    Rehovot, 7660101, Israel

  • Kim's Eye Hospital

    Seoul, 07301, South Korea

  • Kings College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA

    Gliwice, 44-100, Poland

  • Oftalmos

    Capital Federal, C1120AAN, Argentina

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO, Argentina

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Rabin MC

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Retina Consultants of Texas

    Bellaire, Texas, 77401, United States

  • Retina Institute of Ottawa

    Ottawa, Ontario, K2B 7E9, Canada

  • Retina Vitreous Associates of Florida

    Tampa, Florida, 33617, United States

  • Royal Surrey County Hospital

    Guildford, GU2 7XX, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906, Israel

  • Texas Retina Associates

    Arlington, Texas, 76012, United States

  • Toronto Retina Institute

    Toronto, Ontario, M3C 0G9, Canada

  • Verum Research LLC

    Eugene, Oregon, 97401, United States

  • Win Retina

    Arcadia, California, 91006, United States

  • Yeungnam University Medical Center

    Daegu, 42415, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.