Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Global Development, Inc.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)