Neovascular Age-Related Macular DegenerationPhase 3DiagridNCT05126966
A Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration
A Phase 3 study testing Ranibizumab, Aflibercept and Port Delivery System with ranibizumab (PDS) in people with Neovascular Age-Related Macular Degeneration, run by Hoffmann-La Roche at 10 sites in 7 countries.
Trial summary
This study will evaluate the effectiveness and safety of a 36-week refill regimen for the Port Delivery System with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per treat-and-extend (aflibercept T\&E) in subjects with neovascular (wet) age-related macular… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration
- What is being tested?
- Ranibizumab, Aflibercept and Port Delivery System with ranibizumab (PDS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 29 Dec 2023to 30 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Age ≥ 50 years, at time of signing Informed Consent Form
- 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
- Ocular Inclusion Criteria:
- Initial diagnosis of nAMD within 9 months prior to the screening visit
Show all 13Show fewer
- Previous treatment with at least three anti-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 obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
- Availability of historical SD-OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
- BCVA of 34 letters or better (20/200 or better approximate Snellen equivalent), using ETDRS chart at a starting distance of 4 meters (see the BCVA manual for additional details) at screening and randomization visits
- With any subtype of nAMD lesions (i.e., type I, type II, type III, or mixed forms per OCT classification, including polypoidal choroidal vasculopathy and retinal angiomatous proliferation)
- Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of fundus photography (FP), FA, fundus autofluorescence (FAF) image, and SD-OCT images
Who cannot join
- Prior Ocular Treatment - Study Eye
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
- Prior pars plana vitrectomy surgery
- Prior treatment with Visudyne® (verteporfin for injection), external-beam radiation therapy, or transpupillary thermotherapy
- Previous treatment with corticosteroid intravitreal injection
- Previous intraocular device implantation (not including intraocular lens implants)
Show all 74Show fewer
- Previous intraocular surgery (including cataract surgery) within 3 months of randomization
- Previous laser (any type) used for AMD or diabetic retinopathy treatment
- History of vitreous hemorrhage
- History of rhegmatogenous retinal detachment
- Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
- History of corneal transplant
- History of conjunctival surgery in the superotemporal quadrant (including pterygium surgery)
- Prior Ocular Treatment 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 (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations used by a subject during the study
- Any contraindication to aflibercept as per local label
- Prior participation in a clinical trial involving any anti-VEGF drugs within 6 months prior to the randomization visit
- Prior treatment with brolucizumab (at any time prior to the screening visit)
- Prior treatment with external-beam radiation therapy or brachytherapy
- MNV (CNV) Lesion Characteristics Study Eye:
- Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area (1.27 mm^2) in size at screening
- Subfoveal fibrosis or subfoveal atrophy
- MNV (CNV) Lesion Characteristics Either Eye:
- CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio retinopathy, or pathologic myopia
- CNV masquerading lesions (e.g., cone dystrophy, adult vitelliform dystrophy, pattern dystrophy)
- Concurrent Ocular Conditions Study Eye :
- Subfoveal and/or juxtafoveal retinal pigment epithelial tear
- Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification)
- Conjunctival pathologies (e.g., pterygium, scarring, thinning, fibrosis) in the superotemporal quadrant
- Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, epiretinal membrane, amblyopia, or strabismus) 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
- Active intraocular inflammation (grade trace or above)
- Rhegmatogenous retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within 3 months prior to the randomization visit
- Aphakia or absence of the posterior capsule Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
- Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus exam
- Preoperative refractive error that exceeds 8 diopters of myopia, for subjects who have undergone prior refractive or cataract surgery in the study eye
- Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia
- Preoperative refractive error that exceeds 5 diopters of hyperopia, for subjects who have undergone prior refractive or cataract surgery
- Uncontrolled ocular hypertension or glaucoma (defined as intraocular pressure [IOP] > 25 mmHg or a cup to disc ratio > 0.8, despite treatment with anti-glaucoma medication) and any such condition the investigator determines may require a glaucoma-filtering surgery during a subject's participation in the study
- History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis
- Ectropion, entropion, ingrowing lashes, or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure
- Trichiasis
- Corneal neuropathy
- Lagophthalmos or incomplete blink
- Active or history of facial nerve palsy/paresis
- Concurrent Ocular Conditions Non-Study (Fellow) Eye
- Non-functioning non-study eye, defined as either:
- BCVA of hand motion or worse
- No physical presence of non-study eye (i.e., monocular)
- Legally blind in the subject's relevant jurisdiction
- Concurrent Ocular Conditions Either Eye
- Any active or history of uveitis (e.g., idiopathic, drug-associated, or autoimmune-associated uveitis)
- Active or history of keratitis, scleritis, endophthalmitis, or chronic blepharitis
- Suspected or active ocular or periocular infectious conjunctivitis or endophthalmitis
- Active or history of Sjogrens syndrome or keratoconjunctivitis sicca
- Active or history of floppy eyelid syndrome
- Active or history of chronic eye rubbing
- Active thyroid eye disease
- Concurrent Systemic Conditions:
- Inability to comply with study schedule or procedures as described in the study protocol
- Uncontrolled blood pressure (defined as systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg, while a subject is at rest) If a subject's initial measurement exceeds these values, a second reading should be taken ≥ 30 minutes after the first reading If the subject's blood pressure must be controlled by antihypertensive medication, the subject may become eligible if medication is taken continuously for at least 30 days prior to Day 1
- Active or history of autoimmune diseases, for example, rheumatoid arthritis, lupus, granulomatosis with polyangiitis (Wegner's)
- 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 (including uncontrolled diabetes), or clinical laboratory finding (after reviewing the results of the screening laboratory results) giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, aflibercept, or placement of the implant and that might affect interpretation of the results of the study or renders the subject at high risk of treatment complications in the opinion of the investigator
- Confirmed active systemic infection
- Use of any systemic anti-VEGF agents
- Chronic use of oral corticosteroids (> 10 mg/day of prednisone or equivalent)
- Active cancer within 12 months of randomization 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 (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
- Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the randomization visit
- Requirement for continuous use of any medications or treatments prohibited in the study
- Pregnant or breastfeeding, or intending to become pregnant 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-exchange procedure
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Denmark2 sites
Rigshospitalet Glostrup; Afdeling for Øjensygdomme
Glostrup Municipality, 2600
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
Roskilde, 4000
Hong Kong2 sites
Queen Mary Hospital; Department of Ophthalmology
Hong Kong
Hong Kong Eye Hospital; CUHK Eye Centre
Mong Kok
Thailand2 sites
King Chulalongkorn Memorial Hospital; Ophthalmology Department
Bangkok, 10330
Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department
Chiang Mai, 50200
Greece1 site
University Hospital of Larissa; Department of Ophthalmology
Larissa, 412 21
About this study
Official title: A Phase IIIb, Multicenter, Randomized, Visual Assessor-Masked Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration
This study will evaluate the effectiveness and safety of a 36-week refill regimen for the Port Delivery System with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per treat-and-extend (aflibercept T\&E) in subjects with neovascular (wet) age-related macular degeneration (nAMD).
- Being tested
- Ranibizumab, Aflibercept, Port Delivery System with ranibizumab (PDS)
- Keywords
- Wet AMD, neovascular AMD, exudative AMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Ranibizumab will be administered at a dose of 100 mg/mL delivered via the PDS.
AfliberceptDrug
Aflibercept will be administered at a dose of 2 mg in the study eye per treat-and-extend. The decision to extend, maintain, or reduce the interval until next treatment will be per investigator judgment
Port Delivery System with ranibizumab (PDS)Device
PDS is an investigation intraocular drug delivery device designed to continuously deliver anti-VEGF therapy.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Subjects will have the implant (filled intra-operatively prior to implantation with approximately 20 µL of the 100-mg/mL formulation of ranibizumab [approximately 2-mg dose of ranibizumab]) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Subjects will have their implant refilled with ranibizumab at weeks 36 and 72. Receives: Drug: Ranibizumab; Device: Port Delivery System with ranibizumab (PDS) |
| Aflibercept | Active comparator | Subjects will receive intravitreal injections of aflibercept (2mg) administered in the study eye per treat-and-extend. The decision to extend, maintain, or reduce the interval until next treatment will be per investigator judgment. Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BCVA score at week 80 as assessed using the ETDRS visual acuity chart at a starting distance of 4 meters
*Depending on the T\&E schedule, some subjects in the comparator arm will have a visit at Week 76 and some at Week 78. All subjects in both arms will have a Week 80 visit
Measured: From baseline up to 80 weeks
Treatment burden as assessed by the treatment frequency up to Week 80
Treatments include injections and refills.
Measured: From baseline up to 80 weeks
Secondary outcomes (11)
Proportion of subjects with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Weeks 76 (or 78*) and 80
*Depending on the T\&E schedule, some subjects in the comparator arm will have a visit at Week 76 and some at Week 78. All subjects in both arms will have a Week 80 visit
Measured: Baseline, Week 76, Week 78, Week 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
*Depending on the T\&E schedule, some subjects in the comparator arm will have a visit at Week 76 and some at Week 78. All subjects in both arms will have a Week 80 visit
Measured: Baseline, Week 76, Week 78, Week 80
Proportion of subjects who lose < 15, < 10, or < 5 letters in BCVA score from baseline averaged over Weeks 76 (or 78*) and 80
*Depending on the T\&E schedule, some subjects in the comparator arm will have a visit at Week 76 and some at Week 78. All subjects in both arms will have a Week 80 visit
Measured: Baseline, Week 76, Week 78, Week 80
Change from baseline in center point thickness (CPT) at Week 80
*CPT defined as the retinal thickness in the center point of the fovea measured between the internal limiting membrane and the inner third of the retinal pigment epithelium layer, on spectral-domain optical coherence tomography (SD-OCT)
Measured: Baseline, Week 80
Change from baseline in center subfield thickness (CST), defined as the average thickness of the central 1 mm circle of the ETDRS grid centered on the fovea measured between the internal limiting membrane and the Bruch's membrane, on SD-OCT at Week 80
Measured: Baseline, Week 80
Proportion of subjects randomized to PDS Q36W who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure
Measured: Baseline, Week 80
Incidence and severity of ocular and systemic (non-ocular) adverse events
Measured: Baseline, Week 80
Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest
Measured: Baseline, Week 80
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)
Measured: Baseline, Week 80
Incidence and severity of adverse device effects with PDS Q36W
Measured: Baseline, Week 80
Incidence, causality, severity, and duration of anticipated serious adverse device effects with PDS Q36W
Measured: Baseline, Week 80
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start29 Dec 2023 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Why it stopped: Roche/Genentech has initiated an immediate pause of all new PDS implantations because the implants from commercial supply in the clinical studies did not meet the filed specifications for the intended use
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126966
- Sponsor's protocol ID
- MR42410
- Other IDs
- 2021-003226-71
- Acronym
- Diagrid
- Status last verified
- Jan 2024
- First submitted
- 28 Oct 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Multicenter, Randomized, Visual Assessor-Masked Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05126966
- Acronym / sponsor ID
- Diagrid / MR42410
- Keywords
- Wet AMD, neovascular AMD, exudative AMD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Roche/Genentech has initiated an immediate pause of all new PDS implantations because the implants from commercial supply in the clinical studies did not meet the filed specifications for the intended use
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2023 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness and safety of a 36-week refill regimen for the Port Delivery System with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per treat-and-extend (aflibercept T\&E) in subjects with neovascular (wet) age-related macular degeneration (nAMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: Ranibizumab, Device: Port Delivery System with ranibizumab (PDS)Subjects will have the implant (filled intra-operatively prior to implantation with approximately 20 µL of the 100-mg/mL formulation of ranibizumab [approximately 2-mg dose of ranibizumab]) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Subjects will have their implant refilled with ranibizumab at weeks 36 and 72. |
| Aflibercept | Active comparator | Drug: AfliberceptSubjects will receive intravitreal injections of aflibercept (2mg) administered in the study eye per treat-and-extend. The decision to extend, maintain, or reduce the interval until next treatment will be per investigator judgment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed Informed Consent Form
- Age ≥ 50 years, at time of signing Informed Consent Form
- 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
- Initial diagnosis of nAMD within 9 months prior to the screening visit
Key exclusion criteria (74 listed)
- Prior Ocular Treatment - Study Eye
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
- Prior pars plana vitrectomy surgery
- Prior treatment with Visudyne® (verteporfin for injection), external-beam radiation therapy, or transpupillary thermotherapy
- Previous treatment with corticosteroid intravitreal injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanibizumabRanibizumab will be administered at a dose of 100 mg/mL delivered via the PDS. | Drug | Ranibizumab |
| AfliberceptAflibercept will be administered at a dose of 2 mg in the study eye per treat-and-extend. The decision to extend, maintain, or reduce the interval until next treatment will be per investigator judgment | Drug | Aflibercept |
| Port Delivery System with ranibizumab (PDS)PDS is an investigation intraocular drug delivery device designed to continuously deliver anti-VEGF therapy. | Device | Ranibizumab |
Primary outcome
Change from baseline in BCVA score at week 80 as assessed using the ETDRS visual acuity chart at a starting distance of 4 meters
Time frame: From baseline up to 80 weeks
*Depending on the T\&E schedule, some subjects in the comparator arm will have a visit at Week 76 and some at Week 78. All subjects in both arms will have a Week 80 visit
Treatment burden as assessed by the treatment frequency up to Week 80
Time frame: From baseline up to 80 weeks
Treatments include injections and refills.
11 secondary outcomes
Proportion of subjects with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better averaged over Weeks 76 (or 78*) and 80
Time frame: Baseline, Week 76, Week 78, Week 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
Time frame: Baseline, Week 76, Week 78, Week 80
Proportion of subjects who lose < 15, < 10, or < 5 letters in BCVA score from baseline averaged over Weeks 76 (or 78*) and 80
Time frame: Baseline, Week 76, Week 78, Week 80
Change from baseline in center point thickness (CPT) at Week 80
Time frame: Baseline, Week 80
Change from baseline in center subfield thickness (CST), defined as the average thickness of the central 1 mm circle of the ETDRS grid centered on the fovea measured between the internal limiting membrane and the Bruch's membrane, on SD-OCT at Week 80
Time frame: Baseline, Week 80
Proportion of subjects randomized to PDS Q36W who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure
Time frame: Baseline, Week 80
Incidence and severity of ocular and systemic (non-ocular) adverse events
Time frame: Baseline, Week 80
Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest
Time frame: Baseline, Week 80
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)
Time frame: Baseline, Week 80
Incidence and severity of adverse device effects with PDS Q36W
Time frame: Baseline, Week 80
Incidence, causality, severity, and duration of anticipated serious adverse device effects with PDS Q36W
Time frame: Baseline, Week 80
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ranibizumab, Aflibercept and Port Delivery System with ranibizumab (PDS) in people with Neovascular Age-Related Macular Degeneration, run by Hoffmann-La Roche at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 74 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark, Hong Kong, Thailand, Argentina, Greece and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in BCVA score at week 80 as assessed using the ETDRS visual acuity chart at a starting distance of 4 meters (time frame: From baseline up to 80 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.