A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥50 years, at time of signing Informed Consent Form
Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) within 9 months prior to the screening visit
Previous treatment with at least three anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
Best-corrected visual acuity (BCVA) of 34 letters or better
You may not be if
Subfoveal fibrosis or subfoveal atrophy in study eye
Subretinal hemorrhage that involves the center of the fovea in study eye
History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye
Previous intraocular device implantation in study eye
Previous laser (any type) used for AMD treatment in study eye
Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the randomization visit, other than ranibizumab in either eye
CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia in either eye
Uncontrolled blood pressure
History of stroke within the last 3 months prior to informed consent
Uncontrolled atrial fibrillation within 3 months of informed consent
History of myocardial infarction within the last 3 months prior to informed consent
History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications in the opinion of the investigator
Current systemic treatment for a confirmed active systemic infection
Chronic use of oral corticosteroids
Active cancer within 12 months of randomization
Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
Clareo Health | A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration
