This study will evaluate the effectiveness and safety of a 36-week refill regimen for the PDS with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per a treat-and-extend regimen (aflibercept…
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective for this study is to evaluate the effectiveness of PDS
Q36W compared with aflibercept T&E through the co-primary endpoints:
- Change from baseline in BCVA score averaged over Weeks 76 (or 78) and 80, as
assessed using the ETDRS visual acuity chart at a starting distance of 4 meters
- Treatment burden as assessed by the treatment frequency up to Week 80
Secondary outcome
The secondary objective for this study is to evaluate the effectiveness of PDS
Q36W compared with aflibercept T&E on the basis of the following endpoints:
- Proportion of subjects with BCVA score of 69 letters (approximate 20/40
Snellen equivalent) or better averaged over Weeks 76 (or 78) and 80
- Proportion of subjects with BCVA score of 38 letters (approximate 20/200
Snellen equivalent) or worse averaged over Weeks 76 (or 78) and 80
See protocol section 2.1.2 for all secondary objectives
Background summary
Neovascular age-related macular degeneration (nAMD), also known as wet AMD or
choroidal neovascularization (CNV) secondary to AMD, is a form of advanced AMD
that causes rapid and severe visual loss, and remains a leading cause of visual
impairment.
The PDS is an innovative, investigational, intraocular drug delivery system
that allows clinicians to use ranibizumab with a continuous drug delivery
profile. It consists of investigational devices, including an intraocular
implant, four ancillary devices (insertion tool assembly, initial fill needle,
refill needle, and explant tool), and a customized formulation of ranibizumab
tailored for continuous delivery.
Study objective
This study will evaluate the effectiveness and safety of a 36-week refill
regimen for the PDS with ranibizumab 100 mg/mL (PDS Q36W) compared with
intravitreal injections of aflibercept (2 mg) administered per a
treat-and-extend regimen (aflibercept T&E) in subjects with nAMD.
Study design
Study MR42410 is a Phase IIIb, multicenter, randomized, two-arm, visual
assessor-masked trial designed to evaluate the effectiveness and safety of PDS
Q36W compared with aflibercept T&E in subjects with nAMD.
Intervention
One group will receive the implant with ranibizumab and refills every 36 weeks,
the other group will receive aflibercept with an treat-and-extend regimen of
4/8/12 weeks
Study burden and risks
Patients in the implant arm will need surgery and possible surgery to remove
the implant. These surgeries have risks. Patients need to come to site for
checks every 4/8/12 weeks.
Patients in comparator arm will follow a similar regime as they would have in
standard of care. Visits will be longer as more assessments are done that in
standard care.
All patients will have 3 moments where there will be interviewer-administered
questionnaires about their visual function and treatment preference.
At randomisation and at week 80 an aqueous humor sample will be taken.
Beneluxlaan 2a
Woerden 3446 GR
NL
Beneluxlaan 2a
Woerden 3446 GR
NL
Listed location countries
Age
Inclusion criteria
General inclusion criteria
•Age =>50 years, at time of signing Informed Consent Form
•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 3 months after the final intravitreal
injection of ranibizumab or aflibercept, or 1 year after the last implant
refill of ranibizumab
Ocular Inclusion Criteria
•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, as evidenced by the following: a) Overall decrease in nAMD disease
activity detected on SD-OCT, as assessed by the investigator and confirmed by
the central reading center and b) Stable or improved BCVA at randomization
See section 4.1.1 of the protocol for all inclusion criteria
Exclusion criteria
Study Eye
•History of vitrectomy surgery, submacular surgery, or other surgical
intervention for AMD
•Subretinal hemorrhage that involves the center of the fovea
•Subfoveal fibrosis or subfoveal atrophy
Either Eye
•History of a severe allergic reaction or anaphylactic reaction to a biologic
agent or known hypersensitivity to any component of the ranibizumab or
aflibercept injections, study-related procedure preparations, dilating drops,
or any of the anesthetic and antimicrobial preparations used by a subject
•Any contraindication to aflibercept
•Prior participation in a clinical trial involving any anti-VEGF drugs within 6
mths prior to the randomization visit
•CNV due to other causes, such as ocular histoplasmosis, trauma, central serous
chorio-retinopathy, or pathologic myopia
•CNV masquerading lesions
See section 4.1.2 of the protocol for all exclusion criteria
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-003226-71-NL |
| ClinicalTrials.gov | NCT05126966 |
| CCMO | NL78857.100.21 |