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

Korábbi kezelés

• 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
• Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region
• 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

Más betegség

• Macular atrophy secondary to any condition other than STGD1 in either eye
• Presence of intraocular inflammation, macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-macular traction, vitreous hemorrhage or aphakia
• Diabetes mellitus
• Stroke within 12 months of trial entry
• Known serious allergies to the fluorescein dye used in angiography, povidone iodine, or to the components of the avacincaptad pegol formulation

Laborértékek

• Hemoglobin A1c (HbA1c) value of \>/=6.5%

Egyéb

• Women who are pregnant or nursing

• 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