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.
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
There are no exclusion criteria for this LTE study
Parallel
JNJ-81201887
DrugNo study intervention will be administered as part of this LTE study.
Sham Procedure
Other interventionNo study intervention will be administered as part of this LTE study.
Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs)
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
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
Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography) and eye examinations will be reported.
Change from Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score
BCVA will be assessed using the ETDRS chart at a starting distance of 4 meters. The ETDRS score ranges from 0 to 100 letters, where an increase in the number of letters read correctly means that visual acuity has improved and vice-versa.
Click on the lead sponsor to view all of their trials.
