A GLOBAL, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR-MASKED PHASE IIIB STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF A 36-WEEK REFILL SCHEME FOR THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Argentina, Australia, Austria, Belgium, Brazil, France, Germany, Israel, Italy, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (T�rkiye), United Kingdom (ICTRP)

ID di studio ICTRP
NCT04657289 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
A PHASE IIIb, GLOBAL, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR−MASKED STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF A 36-WEEK REFILL REGIMEN FOR THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR (BASEC)

Titolo accademico
A Phase IIIb, Global, Multicenter, Randomized, Visual Assessor-Masked Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) (ICTRP)

Titolo pubblico
A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) (ICTRP)

Malattie studiate
Neovascular Age-related Macular Degeneration (nAMD) (ICTRP)

Intervento studiato
Drug: RanibizumabDevice: Port Delivery System with Ranibizumab (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
Inclusion Criteria:

- Age = 50 years at time of signing Informed Consent Form

- Initial diagnosis of nAMD within 9 months prior to the screening visit

- Previous treatment with at least three anti- vascular endothelial growth factor
(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

- Availability of historical visual acuity data prior to the first anti-VEGF treatment
for nAMD until the time of study enrollment

- BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better

Exclusion Criteria:

- 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 treatment with corticosteroid intravitreal injection, intraocular device
implantation, 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
enrollment visit in study eye

- 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

- Prior treatment with brolucizumab (at any time prior to the screening visit) in
either eye

- Prior participation in a clinical trial involving any anti-VEGF drugs, within 9
months prior to the enrollment visit in either eye

- Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is
>0.5 disc area at screening in study eye

- Subfoveal fibrosis or subfoveal atrophy in study eye

- Choroidal neovascularization (CNV) due to other causes, such as ocular
histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia in
either eye

- Retinal pigment epithelial tear in study eye

- 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 in study eye

- Active intraocular inflammation in study eye

- History of vitreous hemorrhage in study eye

- History of rhegmatogenous retinal detachment in study eye

- History of retinal tears or peripheral retinal breaks within 3 months prior to the
enrollment visit in study eye

- History of pars plana vitrectomy surgery

- Aphakia or absence of the posterior capsule in study eye

- Spherical equivalent of the refractive error demonstrating more than 8 diopters of
myopia in study eye

- Preoperative refractive error that exceeded 8 diopters of myopia, for Participants
who have undergone prior refractive or cataract surgery in study eye

- Intraocular surgery within 3 months preceding the enrollment visit in study eye

- Uncontrolled ocular hypertension or glaucoma and any such condition the investigator
determines may require a glaucoma-filtering surgery during a participant's
participation in the study in study eye

- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma
surgery in study eye

- History of corneal transplant in study eye

- Any history of uveitis requiring treatment in either eye

- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either
eye

- 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,

- 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

- Confirmed active systemic infection

- Use of any systemic anti-VEGF agents

- Active cancer within 12 months of enrollment except for appropriately treated
carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer
with a Gleason score of <= 6 and a stable prostate-specific antigen for > 12 months

- Previous participation in any non-ocular disease studies of investigational drugs
within 1 month preceding the informed consent

- Non-functioning non-study eye (ICTRP)

non disponibile

Endpoint primari e secondari
Change from baseline in Best-corrected visual acuity (BCVA) score averaged over Weeks 68 and 72, as assessed using the ETDRS chart starting at a distance of 4 meters (ICTRP)

Change from baseline in BCVA score over time;Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Weeks 68 and 72;Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better over time;Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse averaged over Weeks 68 and 72;Percentage of participants with BCVA score of 38 letters (approximate 20/200 Snellen equivalent) or worse over time;Percentage of participants who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at At Weeks 24, 40 and 72;Percentage of participants with bilateral disease who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PPPQ at At Weeks 24, 40 and 72;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;Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline averaged over Weeks 68 and 72;Percentage of participants who lose <10, <5, or gain >= 0 letters in BCVA score from baseline over time;Incidence and severity of ocular and systemic (non-ocular) adverse events in the Q36W and Q24W arms;Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in the Q36W and Q24W arms;Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period (= 37 days of initial implantation) and follow-up period (> 37 days after implantation surgery) in all enrolled participants;Incidence and severity of adverse device effects in the Q36W and Q24W arms;Incidence, causality, severity, and duration of anticipated serious adverse device effects in the Q36W and Q24W arms;Change from baseline in center point thickness (CPT) up to and including Week 72;Percentage of participants who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure;Observed serum concentration of ranibizumab at specified timepoints;Incidence of treatment-emergent ADAs during the study (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Clinical Trials;Reference Study ID Number: WR42221 https://forpatients.roche.com/, global-roche-genentech-trials@gene.com, 888-662-6728 (U.S. and Canada), Hoffmann-La Roche, (ICTRP)

ID secondari
2020-001313-20, CIV-21-02-035827, 2023-507130-24-00, WR42221 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT04657289 (ICTRP)