Neovascular age-related macular degeneration (nAMD) MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
F. Hoffman-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Inclusion criteria ?Age >= 50 years ?For women of childbearing potential: agreement to remain abstinent or use contraception and must remain abstinent or use contraceptive methods with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 380
Exclusion criteria
Exclusion criteria: Prior Ocular Treatment o Study Eye ? History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD ? Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy ? Previous treatment with corticosteroid intravitreal injection, intraocular device implantation, previous laser used for AMD treatment ? Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit ? Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant o Either Eye ?Prior treatment with brolucizumab (at any time prior to the screening visit) ?Prior gene therapy for nAMD ?Prior participation in a clinical trial involving any therapies for nAMD, within 9 months from the time of nAMD diagnosis, CNV Lesion Characteristics ? Patients who meet any of the following exclusion criteria related to CNV lesion o Study Eye ? Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area in size at screening ? Subfoveal fibrosis or subfoveal atrophy o Either Eye ? CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia Concurrent Ocular Conditions ? Patients who meet any of the following exclusion criteria related to concurrent ocular conditions o Study Eye ? Retinal pigment epithelial tear ? Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results ? Active intraocular inflammation ? History of vitreous hemorrhage, rhegmatogenous retinal detachment, pars plana vitrectomy surgery, rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit ? Aphakia or absence of the posterior capsule ? Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia ? Preoperative refractive error that exceeded 8 diopters of myopia, for patients who have undergone prior refractive or cataract surgery in the study eye ? Intraocular surgery within 3 months preceding the enrollment visit ? Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study ? History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery ? History of corneal transplant ? Non-functioning fellow (non-study) eye o Either Eye Patients who meet the following exclusion criterion for the either eye at both the screening and enrollment visits will be excluded from study entry ? Any history of uveitis requiring treatment ? Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis Concurrent Systemic Conditions ? Uncontrolled blood pressure ? History of stroke within the last 3 months prior to informed consent ? Atrial fibrillation diagnosed or worsened within the last 3 months prior to informed consent ? History of myocardial infarction within the last 3 months prior to informed consent, other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of ranibizumab 100 mg/mL delivered via the port delivery system with ranibizumab (PDS) every 36 weeks (Q36W) compared with every 24 weeks (Q24W) on the basis of change from baseline in best-corrected visual acuity (BCVA) score averaged over Weeks 68 and 72;Secondary Objective: ? Efficacy of ranibizumab 100 mg/mL delivered via PDS Q36W versus Q24W on basis of change from baseline in BCVA score over time, proportion of patients with BCVA score of 69 letters/better/ 38 letters/ worse over time, proportion of patients who prefer ranibizumab delivered via PDS compared with intravitreal treatment (IVT), proportion of patients with bilateral disease who report preferring ranibizumab delivered via PDS compared with fellow eye IVT, proportion of patients who lose = 0 letters in BCVA score from baseline over time, change from baseline in center point thickness (CPT), proportion of patients who do not undergo supplemental treatment with intravitreal ranibizumab, mean overall treatment satisfaction ? Safety, tolerability of ranibizumab delivered via PDS, and device and procedure related safety ? Pharmacokinetic profile of ranibizumab delivered via PDS ? Formation of anti-drug antibodies (ADAs) to ranibizumab delivered via PDS;Primary end point(s): Change from baseline in BCVA score averaged over Weeks 68 and 72, as assessed using the ETDRS chart starting at a distance of 4 meters;Timepoint(s) of evaluation of this end point: Weeks 68 and 72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in BCVA score over time (up to and including Week 72) 2. Proportion of patients with BCVA score of 69 letters or better averaged over Weeks 68 and 72 3. Proportion of patients with BCVA score of 69 letters or better over time 4. Proportion of patients with BCVA score of 38 letters or worse averaged over Weeks 68 and 72 5. Proportion of patients with BCVA score of 38 letters or worse over time 6. Proportion of patients who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PDS PPPQ at Weeks 24, 40 and 72 7. Proportion of patients with bilateral disease who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PPPQ at Weeks 24, 40 and 72 8. Mean overall treatment satisfaction at Week 40, as measured by the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ) total score in the Q36W arm compared with the Q24W arm 9. Proportion of patients who lose = 0 letters in BCVA score from baseline averaged over Weeks 68 and 72 10. Change from baseline in CPT up to and including Week 72 11. Change from baseline in central subfield thickness (CST) over time , up to and including Week 72 12. Proportion of patients who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure 13. Mean overall treatment satisfaction at Week 40, as measured by the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ) total score in the Q36W arm compared with the Q24W arm 14. Incidence and severity of ocular and systemic adverse events in Q36W and Q24W 15. Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period and follow-up period in all enrolled patients 16. Incidence and severity of adverse device effects in the Q36W and Q24W arms 17. Incidence, causality, severity, and duration of | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Korea, Republic of, Singapore, Spain, Switzerland, Taiwan, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffman-La Roche Ltd
Outcome results
None listed