The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Ranizumab will be administered via a PDS implant per the schedule described in the arm.
Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 68 and 72, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at a Starting Distance of 4 Meters
BCVA letters were measured using EDTRS chart while participants were at a starting distance of 4 meter. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in visual acuity (VA).
Time frame: Baseline, Week 68, Week 72
Change From Baseline in BCVA Score Over Time
BCVA letters were measured using EDTRS chart while participants were at a starting distance of 4 meter. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
Time frame: From baseline up to Week 72
Percentage of Participants Who Lose ≤ 15, ≤ 10, ≤ 5, or Gain ≥ 0 Letters in BCVA Score From Baseline Over Time
BCVA letters were measured using EDTRS chart while participants were at a starting distance of 4 meter. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA.
Time frame: From baseline up to Week 72
Change From Baseline in Center Point Thickness (CPT)
Time frame: From baseline up to Week 72
Change From Baseline in Central Subfield Thickness (CST)
Time frame: From baseline up to Week 72
Proportion of Participants Who do not Undergo Supplemental Treatment With IVT Ranibizumab Before Each Refill-exchange Procedure
Time frame: Up to Week 72
Number of Supplemental Treatments Participants Received in Each Refill Cycle
Time frame: Up to Week 72
Reference Study ID Number: MR45625 https://forpatients.roche.com/ No attachments to email below.
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Medizinische Universität Innsbruck
Innsbruck, Austria
RECRUITINGKepler Universitätskliniken GmbH - Med Campus III
Linz, Austria
RECRUITINGLandesklinikum Mistelbach
Mistelbach, Austria
RECRUITINGKlaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt
Mladá Boleslav, Czechia
RECRUITINGFaculty Hospital Ostrava
Ostrava, Czechia
RECRUITINGFaculty Hospital Kralovske Vinohrady
Prague, Czechia
RECRUITINGUstredni vojenska nemocnice
Prague, Czechia
RECRUITINGAarhus Universitetshospital
Aarhus N, Denmark
RECRUITINGRigshospitalet Glostrup
Glostrup Municipality, Denmark
RECRUITINGInstitut Ophtalmologique De l Ouest Jules Verne
Nantes, Paris, France
RECRUITING...and 51 more locations
Frequency of Study Visits in Each Refill Cycle
Time frame: Up to Week 72
Proportion of Participants Who Report Preferring PDS Compared With IVT Ranibizumab Treatment as Measured by the PDS Patient Preference Questionnaire (PPPQ) at Weeks 24 and 72
Time frame: Weeks 24 and 72
Proportion of Participants With Bilateral Disease Who Report Preferring PDS Compared With IVT Ranibizumab Treatment Measured by the PPPQ at Weeks 24 and 72
Time frame: Weeks 24 and 72
Number of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs)
Time frame: Up to approximately 19 months
Number of Participants With Adverse Events of Special Interests (AESIs) and their Severity, Including Ocular AESIs
Time frame: Up to approximately 19 months
Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Post-operative and Follow-up Period
Time frame: Post-operative period: ≤ 37 days of initial implantation surgery Follow-up period: > 37 days after implantation surgery (up to 72 weeks)
Number of Participants With Adverse Device Effects (ADEs) and Severity of ADEs With PDS
Time frame: Up to approximately 19 months
Number of Participants With Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs With PDS
Time frame: Up to approximately 19 months