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/
CONTACT
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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
RECRUITINGRigshospitalet Glostrup
Glostrup Municipality, Denmark
RECRUITINGInstitut Ophtalmologique De l Ouest Jules Verne
Nantes, Paris, France
RECRUITINGHopital Edouard Herriot - CHU Lyon
Lyon, France
RECRUITINGClinique Honore Cave
Montauban, France
RECRUITINGCHNO des Quinze Vingts
Paris, France
RECRUITINGCHU Poitiers - CHR La Miletrie
Poitiers, France
RECRUITING...and 24 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