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 * Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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 was considered when a participant requires new or additional treatment for that illness. Lack of or insufficient clinical response or efficacy was not recorded as an AE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-drug Antibody (ADA) | Up to 18 months | Number of participants with ADA = Post-baseline positive (in Baseline negative group) + treatment-boosted ADA positive (in Baseline positive group) / participants with a Baseline and at least one post-baseline sample. For participants whose ADA status is positive at Baseline, a post-baseline titer value that is \>= 4 times higher than the Baseline is considered treatment-boosted ADA. |
| Plasma Concentrations of ACP | Months 1, 2, 4, 7, 13, and 18 | Concentrations below the lower limit of quantification (3.36 ng/mL) are set to zero for calculation of summary statistics. |
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.
Participant flow
Recruitment details
Participants who completed study ISEE2008 (NCT04435366; GATHER2) through the Month 23 visit on assigned treatment (avacincaptad pegol \[ACP\] or sham) were enrolled in the study.
Pre-assignment details
Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 77.6 years STANDARD_DEVIATION 8.6 |
| Age, Customized Adolescents (12-17 years) | 0 Participants |
| Age, Customized Adults (18-64 years) | 9 Participants |
| Age, Customized Children (2-11 years) | 0 Participants |
| Age, Customized Elderly 85 years and over | 62 Participants |
| Age, Customized Elderly (From 65-84 years) | 193 Participants |
| Age, Customized Infants and toddlers (28 days-23 months) | 0 Participants |
| Age, Customized In Utero | 0 Participants |
| Age, Customized Newborns (0-27 days) | 0 Participants |
| Age, Customized Pre-term newborn - gestational age < 37 wk | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 39 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 19 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants |
| Race/Ethnicity, Customized White | 57 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 2 / 62 | 3 / 152 |
| other Total, other adverse events | 42 / 64 | 39 / 61 | 93 / 151 |
| serious Total, serious adverse events | 14 / 64 | 13 / 61 | 24 / 151 |
Outcome results
None listed