A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Korea, Republic of, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States (ICTRP)

Identifiant de l'essai ICTRP
EUCTR2020-004427-16 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (PORTAL) (BASEC)

Titre académique
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (PORTAL) - PORTAL (ICTRP)

Titre public
A Study to Evaluate Long-Term Safety and Tolerability of the Port Delivery System with Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration (Portal) (ICTRP)

Maladie en cours d'investigation
Neovascular Age-Related Macular Degeneration (nAMD)
MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] (ICTRP)

Intervention étudiée

Trade Name: Lucentis
Product Name: Ranibizumab
Product Code: [RO4893594]
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Current Sponsor code: na
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 1-

Product Name: RANIBIZUMAB
Product Code: [RO4893594]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Current Sponsor code: na
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

(ICTRP)

Type d'essai
Interventional clinical trial of medicinal product (ICTRP)

Plan de l'étude
Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Patients completed Phase II GX28228 , Phase III GR40548, Phase IIIb WR42221 or completed W24 If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 7 (ICTRP)

Critères d'inclusion/exclusion
Gender:
Female: yes
Male: yes

Inclusion criteria:
- Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study (monthly intravitreal ranibizumab 0.5 mg or implant arms) OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)
- Ability and willingness to undertake all scheduled visits and assessments
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 145
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 890
(ICTRP)

Exclusion criteria:
- Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab
- History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
- History of other diseases, 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 that renders the patient at high risk of treatment complications
- Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"



Critères d'évaluation principaux et secondaires
Main Objective: To evaluate the long-term safety and tolerability of ranibizumab delivered via the Port Delivery System with ranibizumab (PDS) every 24 weeks (Q24W) or every 36 weeks (Q36W) with the 100 mg/mL formulation;Secondary Objective: - To evaluate the efficacy of ranibizumab delivered via the PDS Q24W or Q36W with the 100 mg/mL formulation, as assessed by visual acuity
- To evaluate the efficacy of ranibizumab, delivered via the PDS Q24W or Q36W with the 100-mg/mL formulation, as assessed by center point thickness (CPT) on optical coherence tomography (OCT)
- To evaluate the proportion of patients who undergo supplemental treatment with intravitreal ranibizumab 0.5 mg
;Primary end point(s): 1. Incidence and severity of ocular and systemic (non-ocular) adverse events (AEs)
2. Incidence, severity, and duration of adverse event of special interest (AESIs)
3. Incidence, severity, and duration of ocular AESIs during the postoperative period (up to 37 days of initial implantation) and follow-up period (>37 days after implantation surgery) for patients who receive the implant in the study
4. Incidence and severity of adverse device effects
5. Incidence, causality, severity, and duration of anticipated serious adverse device effects
;Timepoint(s) of evaluation of this end point: 1-5 for cohorts 1-4: up to week 240; for cohorts 5-7: up to week 144 (ICTRP)

Secondary end point(s): 1. Change in best-corrected visual acuity (BCVA) score from baseline over time, as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart at a starting distance of 4 meters
2. Percentage of patients who lose < 15, < 10, or < 5 letters in BCVA score from baseline over time
3. Percentage of patients with BCVA score of 38 letters (of 20/200 approximate Snellen equivalent) or worse over time
4. Percentage of patients with BCVA score of 69 letters (20/40 approximate Snellen equivalent) or better over time
5. Change from baseline in CPT over time
6. Percentage of patients who undergo supplemental treatment with intravitreal ranibizumab 0.5 mg during each refill-exchange interval
;Timepoint(s) of evaluation of this end point: 1. for cohorts 1-4: Baseline to Week 240; for cohorts 5-7: baseline to week 144
2-4. for cohorts 1-4:Up to Week 240; for cohorts 5-7: Up to Week 144
5. for cohorts 1-4:Baseline to Week 240; for cohorts 5-7:Baseline to Week 144
6. for cohorts 1-4:baseline to week 240; for cohorts 5-7: baseline to week 144 (ICTRP)

Date d'enregistrement
29.04.2022 (ICTRP)

Inclusion du premier participant
11.07.2022 (ICTRP)

Sponsors secondaires
non disponible

Contacts supplémentaires
Trial Information Support Line-TISL, global.rochegenentechtrials@roche.com, F. Hoffman-La Roche Ltd (ICTRP)

ID secondaires
GR40549, 2020-004427-16-ES (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004427-16 (ICTRP)