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

Purpose

The purpose of this study is to evaluate the safety and efficacy of avacincaptad pegol intravitreal injection compared to Sham in participants with autosomal recessive Stargardt disease 1 (STGD1).

Condition

Stargardt's Macular Dystrophy

Eligibility

Eligible Ages: Between 18 Years and 60 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental avacincaptad pegol	Participants will receive avacincaptad pegol monthly for up to 17 Months.	Drug: avacincaptad pegol Intravitreal Injection Other names: Zimura (previous name) ARC1905 Izervay
Sham Comparator Sham	Participants will receive a matching sham monthly for up to 17 Months.	Drug: Sham Intravitreal Injection

Recruiting Locations

More Details

NCT ID: NCT03364153
Status: Active, not recruiting
Sponsor: Astellas Pharma Global Development, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.