Cure My Disease

Don't miss your cure!

 Log in / Sign up

New eye drug implant could reduce injections for wet AMD

NCT ID NCT04567303

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 3 times

Summary

This study tests a new drug called zifibancimig for people with wet age-related macular degeneration (AMD), a leading cause of vision loss. The drug is given either as an eye injection or through a small implant placed in the eye that releases the drug over time. The trial involves 177 participants and aims to check safety and how well the drug works.

What this could mean

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

Active substance
zifibancimig (a drug given as an eye injection or through an eye implant)
What this could lead to
If it works, this could lead to a new treatment option for wet age-related macular degeneration that requires fewer eye injections.
What could go wrong
This is an early phase 1/2 trial with only 177 people, so it is not yet proven safe or effective. Side effects from the eye implant or injections are possible.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

177 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Aug 2026

An estimate. End dates often move.

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

50 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.

Part 1, Part 2 and Part 3 Inclusion Criteria: * Willing to allow AH collection Part 1 and Part 2 Ocular Inclusion Criteria for Study Eye: * Choroidal neovascularization (CNV) exclusively due to age-related macular degeneration (AMD) * Anti-vascular endothelial growth factor (VEGF) or anti-VEGF/Angiopoietin-2 (Ang-2) IVT treatment-naïve, or pre-treated with anti-VEGF or anti-VEGF/Ang-2 no less than two months prior to Day 1 * Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), fundus autofluorescence (FAF), and spectral domain optical coherence tomography (SD-OCT) images * Decreased BCVA attributable primarily to nAMD, with BCVA letter score of 78 to 34 letters (inclusive) on ETDRS-like charts at screening. In case both eyes of a participant are eligible, the eye with the lower BCVA score should become the study eye Part 3 Ocular Inclusion Criteria for Study Eye: * CNV exclusively due to AMD * Diagnosis of nAMD within 36 months prior to the screening visit * Previous treatment with at least one IVT anti-VEGF or anti-VEGF/Ang-2 administrations IVT for nAMD. The last IVT administration must have occurred at least 21 days prior to the screening visit * Demonstrated response to prior IVT anti-VEGF or anti-VEGF/Ang-2 treatment since diagnosis * Availability of historical VA data prior to the first anti-VEGF or anti-VEGF/Ang-2 treatment for nAMD * Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading * Decreased BCVA attributable primarily to nAMD with letter score of 78 to 34 letters (inclusive) or better on ETDRS-like charts Ocular Exclusion Criteria for Study Eye: * History of vitrectomy surgery, submacular surgery, other intraocular surgery, or any planned surgical intervention during the study period * Cataract surgery without complications within three months preceding the screening visit or planned during the study period * Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also an exclusion criterion, unless it occurred as a result of yttrium-aluminum garnet laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation * Prior macular treatment with verteporfin, external beam radiation therapy, transpupillary thermotherapy, or any type of laser photocoagulation * Prior treatment with IVT corticosteroids or implant (e.g., triamcinolone, ozurdex, iluvien) * Subretinal hemorrhage \>50% of the total lesion area and/or involving the fovea * Subfoveal fibrosis or subfoveal atrophy * Retinal pigment epithelial tear involving the macula * History of vitreous hemorrhage, rhegmatogenous retinal detachment, glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery, and corneal transplant * History of rhegmatogenous retinal tears or peripheral retinal breaks within three months prior to the screening visit * Actual or history of myopia \>-8 diopters * Uncontrolled ocular hypertension or glaucoma (defined as intraocular pressure \[IOP\] \>25 millimeters of mercury (mm Hg) or a cup to disc ratio \>0.8, despite treatment with antiglaucoma medication) and any such condition the Investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study * Concurrent intraocular conditions (e.g., cataract, diabetic retinopathy, epiretinal membrane with traction, macular hole) that, in the opinion of the Investigator, could either: require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition; or likely contribute to loss of BCVA over the study period if allowed to progress untreated; or preclude any visual improvement due to substantial structural damage * Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PD implant * Prior treatment with any medication for geographic atrophy (GA) during the last 3 months prior to screening * Prior treatment with any anti-VEGF-C or anti-VEGF-D inhibitors Exclusion Criteria for Fellow Eye * BCVA letter score using ETDRS charts of \< 34 letters * Treatment with IVT anti-VEGF or anti-VEGF/Ang-2 agents within one week prior to Day 1 (concurrent treatment with SUSVIMO\^TM in the fellow eye is not exclusionary) Exclusion Criteria for Either Eye * CNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, uveitis or central serous chorioretinopathy * Prior participation in a clinical trial involving anti-VEGF drugs within six months prior to the screening visit, other than ranibizumab, aflibercept, or faricimab including approved biosimilars * Active intraocular inflammation (grade trace or above), infectious conjunctivitis, keratitis, scleritis, or endophthalmitis * History of uveitis, including history of any intraocular inflammation following intravitreal therapy * Prior treatment with brolucizumab * Prior gene therapy for nAMD

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Macular degeneration are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

macular degeneration wet macular degeneration

As listed by the trial registrant

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

Macular degeneration

Contacts and locations

Locations

  • Associated Retina Consultants

    Phoenix, Arizona, 85020, United States

  • Associated Retinal Consultants

    Royal Oak, Michigan, 48073, United States

  • Austin Clinical Research LLC

    Austin, Texas, 78750, United States

  • Austin Research Center for Retina

    Austin, Texas, 78705, United States

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona, 85206, United States

  • Carolina Eyecare Physicians

    Mt. Pleasant, South Carolina, 29464, United States

  • Charles Retina Institute

    Germantown, Tennessee, 38138, United States

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • Duke Eye Center

    Durham, North Carolina, 27705, United States

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612, Puerto Rico

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003, United States

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546, United States

  • Graystone Eye

    Hickory, North Carolina, 28602, United States

  • Johns Hopkins Med

    Baltimore, Maryland, 21287, United States

  • Maine Eye Center

    Portland, Maine, 04101, United States

  • Mid Atlantic Retina - Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • OSU Eye Physicians & Surgeons

    Columbus, Ohio, 43212, United States

  • Orange County Retina Med Group

    Santa Ana, California, 92705, United States

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Retina Associates of Florida, LLC

    Tampa, Florida, 33609, United States

  • Retina Center of Texas

    Southlake, Texas, 76092, United States

  • Retina Consultants of Texas

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Texas

    Houston, Texas, 77030, United States

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815, United States

  • Retina Vit Surgeons/Central NY

    Liverpool, New York, 13088, United States

  • Retina Vitreous Assoc of FL

    St. Petersburg, Florida, 33711, United States

  • Retinal Consultants Med Group

    Sacramento, California, 95841, United States

  • Sierra Eye Associates

    Reno, Nevada, 89502, United States

  • Southeast Retina Center

    Augusta, Georgia, 30909, United States

  • Southeastern Retina Associates

    Knoxville, Tennessee, 37922, United States

  • Southern Vitreoretinal Assoc

    Tallahassee, Florida, 32308, United States

  • Southwest Retina Consultants

    Durango, Colorado, 81303, United States

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204, United States

  • Tennessee Retina PC.

    Nashville, Tennessee, 37203, United States

  • The Retina Institute

    St Louis, Missouri, 63128, United States

  • The Retina Partners

    Encino, California, 91436, United States

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452, United States

  • VitreoRetinal Surgery, PLLC.

    Saint Louis Park, Minnesota, 55416, United States

More trials for these conditions

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