Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)

A Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects With Autosomal Recessive Stargardt Disease

Sponsors

Lead Sponsor: IVERIC bio, Inc.

Source IVERIC bio, Inc.
Brief Summary

To evaluate the safety and efficacy of Zimura™ (complement factor C5 inhibitor) compared to Sham in subjects with autosomal recessive Stargardt disease 1 (STGD1).

Overall Status Recruiting
Start Date 2018-01-12
Completion Date 2024-09-01
Primary Completion Date 2024-09-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Spectral Domain-Optical Coherence Tomography (SD-OCT) 18 months
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Zimura

Description: Zimura Intravitreal Injection

Arm Group Label: Cohort 1

Other Name: avacincaptad pegol

Intervention Type: Other

Intervention Name: Sham

Description: Sham Intravitreal Injection

Arm Group Label: Cohort 2

Eligibility

Criteria:

Inclusion Criteria: - At least two pathogenic mutations of ABCA4 gene confirmed by a 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 - 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 Zimura formulation

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Sonia Cruz

Phone: 347-322-8722

Email: [email protected]

Location
Facility: Status: Contact:
Retinal Consultants of Arizona | Phoenix, Arizona, 85053, United States Recruiting 602-222-2221
Jules Stein Eye Institute/ David Geffen School of Medicine | Los Angeles, California, 90095, United States Recruiting 310-267-5278
VitreoRetinal Associates | Gainesville, Florida, 32607, United States Recruiting 352-300-8412
Retinal Specialty Institute | Pensacola, Florida, 32503, United States Recruiting
Wilmer Eye Institute, Johns Hopkins | Baltimore, Maryland, 21287, United States Completed
Ophthalmic Consultants of Boston | Boston, Massachusetts, 02114, United States Completed
Kellogg Eye Center | Ann Arbor, Michigan, 48105, United States Recruiting 734-936-9798
Retina Center P.A. | Minneapolis, Minnesota, 55404, United States Recruiting 612-747-5644
Envision Ocular, LLC | Bloomfield, New Jersey, 07003, United States Recruiting 973-707-5632
Oregon Health & Science University | Portland, Oregon, 97239, United States Recruiting 503-494-3115
Mid Atlantic Retina | Philadelphia, Pennsylvania, 19107, United States Recruiting 215-928-3092
UPMC Eye Center | Pittsburgh, Pennsylvania, 15213, United States Completed
Palmetto Retina Center | West Columbia, South Carolina, 29169, United States Recruiting 803-404-5038
Austin Retina Associates | Austin, Texas, 78705, United States Recruiting 512-451-0103
Retina Foundation of the Southwest | Dallas, Texas, 75231, United States Recruiting 214-363-3911
Strategic Clinical Research Group | Willow Park, Texas, 76087, United States Recruiting 682-703-4324
University of Utah John A. Moran Eye Center | Salt Lake City, Utah, 84132, United States Recruiting 801-581-6265
Montreal Children's Hospital | Montréal, H4A 3J1, Canada Withdrawn
Hopital de la Croix-Rousse | Lyon, Rhone-Alpes, 69317, France Completed
Hopital Intercommunal de Verdun, University Paris Est | Créteil, 94000, France Completed
Centre ophtalmologique des Quinzes Vingts | Paris, 75012, France Completed
University of Bonn | Bonn, 53127, Germany Completed
Augenklinik und Poliklinik des Klinikums der Universitat München | München, 80336, Germany Completed
Universitätsklinikum Tübingen | Tübingen, 72076, Germany Completed
Budapest Retina Associates | Budapest, 1133, Hungary Completed
Semmelweis University, Ophthalmology Clinics | Budapest, H-1085, Hungary Completed
Debreceni Egyetem Klinikai Kozpont Szemklinika | Debrecen, 4032, Hungary Completed
Ganglion Medical Center | Pécs, 7621, Hungary Completed
Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont, Szemeszeti Klinika | Szeged, 6720, Hungary Completed
Rambam Health Care Campus | Haifa, 310960, Israel Completed
Hadassah Medical Center | Jerusalem, 91120, Israel Completed
Rabin Medical Center, Beilinson campus | Petah tikva, 4941492, Israel Completed
Kaplan Medical Center | Reẖovot, 7610001, Israel Completed
Tel-Aviv Sourasky Medical Center, Ichilov Hospital | Tel Aviv, 64239, Israel Completed
AOU Policlinico Sant'Orsola Malpighi, U.O. Oftalmologia, | Bologna, 40138, Italy Completed
AOU Careggi | Florence, 50134, Italy Completed
IRCCS Ospedale San Raffaele | Milano, 20132, Italy Completed
AOU Universita degli studi della Campania Luigi Vanvitelli - UOC Oculistica | Naples, 80131, Italy Completed
Foundation Policlinico Tor Vergata, UOSD Patologie Retiniche | Rome, 00133, Italy Completed
Institut de la Macula | Barcelona, 08022, Spain Completed
Princess Alexandra Eye Pavillion | Edinburgh, EH3 9HA, United Kingdom Completed
Moorfields Eye Hospital | London, EC1V 2PD, United Kingdom Completed
Location Countries

Canada

France

Germany

Hungary

Israel

Italy

Spain

United Kingdom

United States

Verification Date

2022-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Cohort 1

Type: Experimental

Description: Zimura dose group

Label: Cohort 2

Type: Sham Comparator

Description: Sham dose group

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stargardt Disease 1

Clinical Trials on Zimura