Geographic Atrophy, Age-Related Macular Degeneration
Conditions
Keywords
Geographic Atrophy;, Macular Degeneration;, ARC1905;, Avacincaptad pegol;, Zimura (previous name);, Izervay
Brief summary
The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 23 visit on study treatment (either avacincaptad pegol or Sham).
Interventions
Intravitreal Injection
Sponsors
Astellas Pharma Global Development, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment. * Patient must provide new written informed consent for this OLE trial prior to participation. * Patient must have the ability to return for all trial visits for the duration of the 18-month trial.
Exclusion criteria
* Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham). * Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible. * Patient did not enroll into this OLE trial within the 90 day enrollment period. * Patient who is pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Up to 18 Months | An AE is defined as any untoward medical occurrence in a participant including unfavorable and unintended signs, symptoms or disease temporally associated with the use of a medicinal product and which does not necessarily have to have a causal relationship to this treatment. AEs include illnesses with onset during the trial, or exacerbations of pre-existing illnesses. Exacerbation of pre existing illness is defined as a significant increase in the severity of the illness as compared to the start of the trial and should be considered when a participant requires new or additional treatment for that illness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Anti-Drug Antibody (ADA) status | Up to 18 Months | ADA will be recorded from the serum samples collected. Overall ADA status will be reported: ADA-negative, ADA positive, ADA-inconclusive and unevaluable sample. |
| Pharmacokinetics (PK) of avacincaptad pegol in plasma: concentration | Up to 18 Months | Concentration will be recorded from the PK plasma samples collected. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, France, Germany, Hungary, Israel, Italy, Latvia, Spain, United States
Contacts
STUDY_DIRECTORMedical Director
Astellas Pharma Global Development, Inc.
Outcome results
None listed