geographic atrophy secondary to age-related macular degeneration
Conditions
Interventions
Patients that are participating are being treated with lampalizumab in a Q4W or
Q6W dosing schedule.
Macular degeneration
open label extention
Phase IIIb
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Willingness and ability to provide signed informed consent Additionally, at U.S. sites, patients must provide Health Insurance Portability and Accountability Act (HIPAA) authorization, and in other countries, as applicable according to national laws. • Willingness and ability to undertake all scheduled visits and assessments • Previous enrollment in and completion of study treatment and the Week 96 visit of either Study GX29185 or Study GX29176, without early treatment discontinuation (lampalizumab or sham) • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of
Exclusion criteria
Exclusion criteria: • Concurrent ocular conditions exclusion criterion History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of lampalizumab or that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications • Concurrent systemic conditions exclusion criteria History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of lampalizumab or that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications; Predisposition to or history of increased risk of infection (see Section 4.1.2 of the protocol); Requirement for continuous use of any medications or treatments indicated in the *Excluded Therapy* section of the protocol (see Section 4.4.2) Pregnancy or lactation, or intention to become pregnant during the study (see Section 4.1.2 of the protocol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Incidence and severity of ocular adverse events • Incidence and severity of systemic (non-ocular) adverse events | — |
Countries
The Netherlands
Outcome results
None listed