A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)

NCT06510816 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: ANX007-GA-022024-515022-88-00
• Study Type: interventional
• Target: 659
• Locations: 13 countries
• Sites: 130

Brief Summary

The primary purpose of the study is to determine if IVT injections of vonaprument every month reduce vision loss in participants with dry AMD with GA.

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits

  Baseline through Month 15

Secondary Outcomes (4)

• Time to Confirmed BCVA ≥15-letter Loss

  Baseline to Month 15 and Baseline to Month 24

• Proportion of Participants Experiencing a Confirmed BCVA ≥15-letter Loss

  Baseline through Month 24

• Proportion of Participants with Low-luminance BCVA (LLVA) ≥15-letter Loss

  Baseline through Month 15 and Baseline through Month 24

• Change from Baseline in Area of Total Loss of the Ellipsoid Zone (EZ) Layer

  Baseline, Month 15 and 24

Study Arms (2)

Vonaprument

EXPERIMENTAL

Participants will receive vonaprument IVT injections every month during the 24-month treatment period.

Drug: Vonaprument

Sham Group

SHAM COMPARATOR

Participants will receive Sham IVT injections every month during the 24-month treatment period.

Other: Sham Administration

Interventions

Sham Administration OTHER

Form and Route of Administration: to mimic IVT injection (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to stimulate the pressure of an injection).

Sham Group

Vonaprument DRUG

Form: solution for injection; Route of Administration: IVT injection

Also known as: ANX007

Vonaprument

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of dry AMD with GA as determined by the Investigator and confirmed by the independent Central Reading Center.

You may not qualify if:

• Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil maculopathy) in either eye.

Sponsors & Collaborators

• Annexon, Inc.: lead

Study Sites (132)

Retina Macula Institute of Arizona

Scottsdale, Arizona, 85255, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Retinal Consultants of Orange County Clinical Research Institute Inc

Fullerton, California, 92835, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

Retina Consultants Medical Group

Modesto, California, 95356, United States

Location

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California, 94040, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95825, United States

Location

Macula Retina Vitreous Research Institute

Torrance, California, 90503, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Retina Consultants of Southern Colorado PC

Colorado Springs, Colorado, 80909, United States

Location

RSC Research, LLC

Denver, Colorado, 80222, United States

Location

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Florida Retina Institute

Orlando, Florida, 32806, United States

Location

Fort Lauderdale Eye Institute

Plantation, Florida, 33324, United States

Location

Retina Group of Florida

Sarasota, Florida, 34232, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Retina Associates of Florida

Tampa, Florida, 33609, United States

Location

Georgia Retina PC

Marietta, Georgia, 30060, United States

Location

Retina Consultants of Hawaii

‘Aiea, Hawaii, 96701, United States

Location

Retina Associates Ltd

Elmhurst, Illinois, 60126, United States

Location

University Retina

Oak Forest, Illinois, 60452, United States

Location

Springfield Clinic LLP

Springfield, Illinois, 62703, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Maine Eye Center

Portland, Maine, 04101, United States

Location

Retina Group of Washington

Chevy Chase, Maryland, 20815, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Mid Atlantic Retina Specialists

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Retina Research Institute at New England Retina Consultants

Springfield, Massachusetts, 01107, United States

Location

Retina Consultants of Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Envision Ocular, LLC

Bloomfield, New Jersey, 07003, United States

Location

Mid Atlantic Retina New Jersey

Cherry Hill, New Jersey, 08054, United States

Location

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

Long Island Vitreoretinal Consultants

Hauppauge, New York, 11788, United States

Location

Asheville Eye Associates - Retina Division

Asheville, North Carolina, 28803, United States

Location

North Carolina Retina Associates

Cary, North Carolina, 27511, United States

Location

North Carolina Retina Associates

Wake Forest, North Carolina, 27587, United States

Location

Piedmont Retina Specialists

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Retina Vitreous Center

Edmond, Oklahoma, 73013, United States

Location

Tulsa Retina Consultants

Tulsa, Oklahoma, 74114, United States

Location

Verum Research, LLC

Eugene, Oregon, 97401, United States

Location

Eyehealth Northwest Portland

Portland, Oregon, 97209, United States

Location

Cascade Medical Research Institute

Springfield, Oregon, 97477, United States

Location

Erie Retina Research, LLC

Erie, Pennsylvania, 16507, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

Palmetto Retina Center

Aiken, South Carolina, 29802, United States

Location

Retina Consultants of Charleston

Beaufort, South Carolina, 29901, United States

Location

Charleston Neuroscience Center

Charleston, South Carolina, 29414, United States

Location

Southeastern Retina Associates

Johnson City, Tennessee, 37604, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Southwest Retina Specialists

Amarillo, Texas, 79106, United States

Location

Texas Retina Associates- Arlington

Arlington, Texas, 76012, United States

Location

Austin Research Center for Retina

Austin, Texas, 78705, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Austin Clinical Research, LLC

Austin, Texas, 78750, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Texas Retina Associates

Fort Worth, Texas, 76104, United States

Location

Retina Consultants of Texas

Katy, Texas, 77494, United States

Location

Tennessee Retina PC

Nashville, Texas, 37203, United States

Location

Retina Consultants of Texas San Antonio

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

Rocky Mountain Retina Consultants

Salt Lake City, Utah, 84107, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Eye Clinic of Wisconsin

Wausau, Wisconsin, 54403, United States

Location

Eye Clinic Albury Wodonga

Albury, New South Wales, 2640, Australia

Location

Marsden Eye Specialists

Parramatta, New South Wales, 2150, Australia

Location

Strathfield Retina Clinic

Strathfield, New South Wales, 2135, Australia

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, 2000, Australia

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Kepler Universitätsklinikum

Linz, 4020, Austria

Location

Calgary Retina Consultants

Calgary, Alberta, T2H 0C8, Canada

Location

Alberta Retina Consultants

Edmonton, Alberta, T5H 0X5, Canada

Location

Ivey Eye Institute

London, Ontario, N6A 4V2, Canada

Location

Retina Centre of Ottawa

Ottawa, Ontario, K2B 7E9, Canada

Location

Fakultní nemocnice Královské Vinohrady

Prague, 100 34, Czechia

Location

Všeobecná fakultní nemocnice V Praze

Prague, 128 08, Czechia

Location

Axon Clinical, s.r.o. Ocni Klinika

Prague, 150 00, Czechia

Location

Groupe Hospitalier Pellegrin - CHU de Bordeaux

Bordeaux, 33076, France

Location

Centre Hospitalier Intercommunal De Créteil

Créteil, 94000, France

Location

CHU Dijon Bourgogne - Hôpital François Mitterrand

Dijon, 21079, France

Location

Centre Ophtalmologique Pôle Vision Val d'Ouest

Écully, France

Location

Centre Monticelli Paradis d'Ophtalmologie

Marseille, France

Location

Centre Hospitalier Universitaire de Nice

Nice, 06001, France

Location

Hôpital Lariboisière - Service d'ophtalmologie

Paris, 75010, France

Location

Centre Ophtalmologique Maison Rouge

Strasbourg, 67000, France

Location

Dietrich Bonhoeffer Klinikum Klinik für Augenheilkunde

Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

Location

Augenzentrum am St. Franziskus-Hospital

Münster, North Rhine-Westphalia, 48145, Germany

Location

Universitäts-Klinikum Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Tübingen, Department für Augenheilkunde

Tübingen, 72076, Germany

Location

Ganglion Medical Center

Pécs, Baranya, 7621, Hungary

Location

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Semmelweis Egyetem

Budapest, 1085, Hungary

Location

Budapesti Bajcsy-Zsilinszky Kórház és Rendelőintézet Szemészet Osztály

Budapest, 1106, Hungary

Location

Budapest Retina Associates

Budapest, 1133, Hungary

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

IRCCS MultiMedica

Milan, 20123, Italy

Location

ASST Fatebenefratelli Sacco

Milan, 20157, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia - Presidio

Roma, 00184, Italy

Location

Fondazione PTV Policlinico Tor Vergata

Rome, 00133, Italy

Location

Fondazione Policlinico Agostino Gemelli

Rome, 00168, Italy

Location

Elisabeth Hospital (ETZ) - location TweeSteden ziekenhuis

Tilburg, 5042 AD, Netherlands

Location

Southern Eye Specialists

Christchurch, Canterbury, 8013, New Zealand

Location

Capital Eye Specialists

Te Aro, Wellington Region, 6011, New Zealand

Location

Oftalmika Sp.Zo.O.

Bydgoszcz, 85-631, Poland

Location

Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. Z O.O.

Olsztyn, 10-424, Poland

Location

Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o.

Rzeszów, 35-017, Poland

Location

Caminomed Sp. Z O.O.

Tarnowskie Góry, 42-600, Poland

Location

Warszawski Szpital Okulistyczny

Warsaw, 01-258, Poland

Location

Oftalvist IMED Burjassot

Valencia, Burjassot, 46100, Spain

Location

Institut Català de Retina

Barcelona, 08017, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Arruzafa - Metavisión Arruzafa

Córdoba, 14012, Spain

Location

Clínica Baviera

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, 28222, Spain

Location

Hospital Universitari General de Catalunya - Valles Ophthalmology Research - OMIQ Research

Sant Cugat del Vallès, 08195, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Moorfields Eye Hospital NHS foundation Trust

Greater London, London, EC1V 2PD, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

The Retina Clinic London

London, W1G 9AX, United Kingdom

Location

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Clinical Trials

  Annexon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-masked

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10); NZ (2); GB (3); CA (4); CZ (3); HU (5); IT (8); DE (5); FR (8); PL (5); US (71); AU (5); NL (1)