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New eye injection shows promise for Diabetes-Related vision loss

NCT ID NCT05151731

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a new drug called vamikibart, given as an eye injection, for people with diabetic macular edema—a condition where diabetes causes fluid buildup in the center of the retina, leading to vision loss. The study involved 394 participants and compared vamikibart to an existing treatment (ranibizumab) or a sham procedure. The main goal was to see if vamikibart could improve vision over 48 weeks, while also checking for side effects.

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), an eye injection
What this could lead to
If it works, this could offer a new treatment option for diabetic macular edema, potentially improving vision with fewer injections.
What could go wrong
This is an early-phase trial with only 394 participants, so results may not apply to everyone. The drug is injected directly into the eye, which carries risks like infection or inflammation.

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

394 people

The number who actually took part.

Started

Dec 2021

Finished

Apr 2025

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

  • AXON Clinical

    Prague, Czechia

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Austin Clinical Research LLC

    Austin, Texas, 78750, United States

  • Bay Area Retina Associates

    Walnut Creek, California, 94598, United States

  • Black Hills Eye Institute

    Rapid City, South Dakota, 57701, United States

  • Bristol Eye Hospital

    Bristol, BS1 2LX, United Kingdom

  • Buenos Aires Mácula

    Ciudad Autonoma Buenos Aires, C1061AAE, Argentina

  • Butchertown Clinical Trials

    Louisville, Kentucky, 40206, United States

  • Caminomed

    Tarnowskie Góry, 42-600, Poland

  • Centro Oftalmologico Dr. Charles S.A.

    Capital Federal, C1116, Argentina

  • Centro Privado de Ojos Romagosa

    Córdoba, Argentina

  • Centro de ojos Loria

    Lomas de Zamora, Argentina

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    Olsztyn, 10-424, Poland

  • Centrum Medyczne UNO-MED

    Krakow, 31-070, Poland

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456, United States

  • Colorado Retina Associates, PC

    Lakewood, Colorado, 80228, United States

  • Cumberland Valley Retina PC

    Hagerstown, Maryland, 21740, United States

  • Deep Blue Retina PLLC

    Southaven, Mississippi, 38671, United States

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612, Puerto Rico

  • Emerson Clinical Research Institute LLC

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

  • Erie Retinal Surgery

    Erie, Pennsylvania, 16507, United States

  • Eye Care Specialists, PC

    Kingston, Pennsylvania, 18704, United States

  • EyeHealth Northwest

    Portland, Oregon, 97225, United States

  • Faculty Hospital Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Faculty Hospital Ostrava

    Ostrava, 708 52, Czechia

  • Florida Retina Institute

    Orlando, Florida, 32806-1101, United States

  • General Teaching Hospital Prague

    Prague, 128 08, Czechia

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucestershire, GL1 3NN, United Kingdom

  • Grupo Laser Vision

    Rosario, S2000DLA, Argentina

  • Hospital General de Catalunya

    Sant Cugat de Valles, Barcelona, 08190, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222, Spain

  • Institut De L'Oeil Des Laurentides

    Boisbriand, Quebec, J7H 0E8, Canada

  • Kim's Eye Hospital

    Seoul, 07301, South Korea

  • LensClinic

    Rybnik, 44-203, Poland

  • Meridian Clinical Research

    Cincinnati, Ohio, 45219, United States

  • Microcirugía Ocular S.A

    Rosario, S2000CTC, Argentina

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD, United Kingdom

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912, United States

  • Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA

    Gliwice, 44-100, Poland

  • Oftalmos

    Capital Federal, C1120AAN, Argentina

  • Oftalvist Valencia

    Burjassot, Valencia, 46100, Spain

  • Oftar

    Mendoza, M5500GGK, Argentina

  • Opthalmic Consultants of LI

    Lynbrook, New York, 11563, United States

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO, Argentina

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Rand Eye

    Deerfield Beach, Florida, 33064, United States

  • Retina Consultants of Nashville

    Nashville, Tennessee, 37203, United States

  • Retina Consultants of Texas

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Texas

    The Woodlands, Texas, 78240, United States

  • Retina Consultants, San Diego

    Poway, California, 92064, United States

  • Retina Institute of Ottawa

    Ottawa, Ontario, K2B 7E9, Canada

  • Retina Specialists of Tampa

    Wesley Chapel, Florida, 33544, United States

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33607, United States

  • Retinal Consultants Med Group

    Sacramento, California, 95825, United States

  • Royal Surrey County Hospital

    Guildford, GU2 7XX, United Kingdom

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • SPSK nr 1 w Lublinie

    Lublin, 20-079, Poland

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Sewickley Eye Group

    Sewickley, Pennsylvania, 15143, United States

  • Sierra Eye Associates

    Reno, Nevada, 89502, United States

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087, United States

  • Texas Retina Associates

    Arlington, Texas, 75075, United States

  • Toronto Retina Institute

    Toronto, Ontario, M3C 0G9, Canada

  • University of Rochester Flaum Eye Institute

    Rochester, New York, 14642, United States

  • Uniwersyteckie Centrum Kliniczne

    Katowice, 40-514, Poland

  • Valley Retina Institute P.A.

    McAllen, Texas, 78503, United States

  • Verum Research LLC

    Eugene, Oregon, 97401, United States

  • Wagner Macula & Retina Center

    Norfolk, Virginia, 23502, United States

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803, United States

  • Win Retina

    Arcadia, California, 91006, United States

  • Yeungnam University Medical Center

    Daegu, 42415, South Korea

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