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New drug aims to slow vision loss in rare eye disease

NCT ID NCT03364153

Disease control Sponsor: Astellas Pharma Global Development, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested an experimental drug called Zimura in 121 people with Stargardt disease, a genetic condition that causes vision loss. Participants received either Zimura injections or a sham procedure. The goal was to see if Zimura could safely slow damage to the retina over 18 months. The trial is complete, and results will help determine if further testing is warranted.

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

121 people

The number who actually took part.

Started

Jan 2018

Finished

Mar 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 to 60 years

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: * At least two pathogenic mutations of ATP-Binding Cassette (ABC)A4 gene confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory * Best corrected visual acuity in the study eye between 20/20 - 20/200 Snellen equivalent, inclusive Exclusion Criteria: * Macular atrophy secondary to any condition other than STGD1 in either eye * Any prior treatment for STGD1 including gene therapy, stem cell therapy or any prior intravitreal treatment for any indication in either eye * Participation in an interventional study of a vitamin A derivative \</= 3 months prior to screening * Presence of intraocular inflammation, macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-macular traction, vitreous hemorrhage or aphakia * Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region * Diabetes mellitus * Hemoglobin A1c (HbA1c) value of \>/=6.5% * Stroke within 12 months of trial entry * Any major surgical procedure within one month of trial entry or anticipated during the trial * Any treatment with an investigational agent in the past 60 days for any condition * Women who are pregnant or nursing * Known serious allergies to the fluorescein dye used in angiography, povidone iodine, or to the components of the avacincaptad pegol formulation

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Conditions

The condition(s) this trial relates to.

severe early-childhood-onset retinal dystrophy Stargardt disease

As listed by the trial registrant

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

Stargardt's macular dystrophy

Contacts and locations

Locations

  • AOU Policlinico Sant'Orsola Malpighi, U.O. Oftalmologia,

    Bologna, 40138, Italy

  • Augenklinik der LMU München

    München, 80336, Germany

  • Austin Retina Associates

    Austin, Texas, 78705, United States

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50121, Italy

  • Budapest Retina Institute

    Budapest, 1133, Hungary

  • Casey Eye Institute/Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Centre ophtalmologique des Quinzes Vingts

    Paris, 75012, France

  • Creteil University Eye Clinic University Paris EST

    Créteil, 94010, France

  • Fondazione Policlinico Tor Vergata, UOSD Patologie Retiniche

    Rome, 00133, Italy

  • Ganglion Medical Center

    Pécs, 7621, Hungary

  • Hadassah University Hospital

    Jerusalem, 9112001, Israel

  • Hopital de la Croix-Rousse

    Lyon, Auvergne-Rhône-Alpes, 69004, France

  • Institut de la Macula

    Barcelona, 08022, Spain

  • Jules Stein Eye Institute/ David Geffen School of Medicine

    Los Angeles, California, 90095, United States

  • Kaplan Medical Center

    Rehovot, 7610001, Israel

  • Moorfields Eye Hospital

    London, EC1V 2PD, United Kingdom

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114, United States

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169, United States

  • Princess Alexandra Eye Pavillion

    Edinburgh, EH3 9HA, United Kingdom

  • Rabin Medical Center, Beilinson campus

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Retina Center of NJ, LLC.

    Bloomfield, New Jersey, 07003, United States

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231, United States

  • Retina Specialty Institute

    Pensacola, Florida, 32503, United States

  • Retinal Research Institute

    Phoenix, Arizona, 85053, United States

  • Semmelweis Egyetem

    Budapest, H-1083, Hungary

  • Strategic Clinical Research Group

    Willow Park, Texas, 76087, United States

  • Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont, Szemeszeti Klinika

    Szeged, 6720, Hungary

  • Tel-Aviv Sourasky Medical Center, Ichilov Hospital

    Tel Aviv, 6423906, Israel

  • The Retina Center

    Minneapolis, Minnesota, 55404, United States

  • UPMC Eye Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Bonn

    Bonn, 53127, Germany

  • University of Campania Luigi Vanvitelli Eye Clinic

    Naples, 80131, Italy

  • University of Debrecen DE KK Szemészeti Klinika

    Debrecen, 4032, Hungary

  • University of Michigan/Kellogg Eye Center

    Ann Arbor, Michigan, 48105, United States

  • University of Tuebingen

    Tübingen, 72076, Germany

  • University of Utah John A. Moran Eye Center

    Salt Lake City, Utah, 84132, United States

  • VitreoRetinal Associates

    Gainesville, Florida, 32607, United States

  • Wills Eye Hospital/Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107, United States

  • Wilmer Eye Institute, Johns Hopkins

    Baltimore, Maryland, 21287, United States