Geographic Atrophy, Macular Degeneration
Conditions
Brief summary
The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.
Interventions
DRUGJNJ-81201887
No study intervention will be administered as part of this LTE study.
OTHERSham Procedure
No study intervention will be administered as part of this LTE study.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Long-term safety study of a single intravitreal dose of JNJ-81201887 administered during parent studies (81201887MDG2001: Randomized trial; 81201887MDG1003: Non-randomized trial)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003) * Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contraception in this LTE study * Must sign an informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs) | Upto 5 Years | Number of participants with ocular and systemic TEAEs will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any adverse event occurring at or after the administration of study intervention. |
| Number of Participants with Abnormal Findings in Clinical Laboratory Assessments | Upto 5 Years | Number of participants with abnormal findings in clinical laboratory Assessments (including hematology and clinical chemistry) will be reported. |
| Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations | Upto 5 Years | Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography, Color Fundus Photography) and eye examinations will be reported. |
Countries
Australia, Belgium, Canada, China, Czechia, Denmark, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed