Neovascular Age-related Macular DegenerationPhase 3SightspireNCT06847542
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
A Phase 3 study testing Susvimo PDS Implant and Ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Hoffmann-La Roche at 61 sites in 13 countries.
Trial summary
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. 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?
- Susvimo PDS Implant and Ranibizumab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 61 sitesin 13 countries
- Study dates
- 27 Nov 2025to 15 Nov 2028
- Phase
- Phase 3
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
- Initial diagnosis of nAMD within 24 months prior to screening
- Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening
- Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
- Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
- Availability of historical 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 using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits
Who cannot join
- Prior Ocular Treatment
- Study Eye:
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
- Previous treatment with corticosteroid intravitreal injection
- Previous intraocular device implantation
- History of vitreous hemorrhage
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- History of rhegmatogenous retinal detachment
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
- History of corneal transplant
- Either Eye:
- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the ranibizumab injections, study-related procedure preparations (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study
- Prior participation in a clinical trial involving any experimental therapies for nAMD
- Prior treatment with brolucizumab or gene therapy for nAMD
- Macular Neovascularization/Choroidal Neovascularization (MNV/CNV) Lesion Characteristics:
- Study Eye:
- Subretinal hemorrhage that involves the center of the fovea
- Subfoveal fibrosis or subfoveal atrophy
- Either Eye:
- CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorioretinopathy, or pathologic myopia
- CNV masquerading lesions
- Concurrent Ocular Conditions:
- Study Eye:
- Subfoveal and/or juxtafoveal retinal pigment epithelial tear
- 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
- Active intraocular inflammation
- Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated or treated within 3 months prior to the enrollment visit
- Aphakia or absence of the posterior capsule
- Uncontrolled ocular hypertension or glaucoma
- History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis
- Trichiasis
- Corneal neuropathy
- Lagophthalmos or incomplete blink
- Active or history of facial nerve palsy/paresis
- Fellow (Non-study) Eye:
- Non-functioning non-study eye defined as either: BCVA of hand motion or worse OR no physical presence of non-study eye (i.e., monocular)
- Either Eye:
- Any active or history of 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 floppy eyelid syndrome
- Active thyroid eye disease
- Concurrent Systemic Conditions:
- Uncontrolled blood pressure
- Active or history of autoimmune diseases
- 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 (MI) within the last 3 months prior to informed consent
- Confirmed active systemic infection
- 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
- Use of any systemic anti-VEGF agents
- Chronic use of oral corticosteroids
- Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer
Trial locations and contacts
61 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: MR45625 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
61 sites in 13 countries
Poland9 sites, 9 recruiting
- Recruiting
Szpital sw. Lukasza
Bielsko-Biala, 43-309
- Recruiting
Specjalistyczny O?rodek Okulistyczny Oculomedica
Bydgoszcz, 85-316
- Recruiting
OFTALMIKA Sp. z o.o
Bydgoszcz, 85-631
- Recruiting
Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
Gliwice, 44-100
- Recruiting
MW-med
Krakow, Lesser Poland Voivodeship, 31 416
- Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, 31-501
- Recruiting
Klinika Okulistyczna Jasne Błonia Sp. z o. o.
Lódz, 91-134
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie;Klinika Chirurgii Siatkówki i Cia?a Szklistego
Lublin, 20-079
- Recruiting
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, 10-424
South Korea7 sites, 6 recruiting
- Recruiting
Kyungpook National University Hospital
Daegu, 41944
- Recruiting
Ajou University Medical Center
Gyeonggi-do, 16499
- Withdrawn
Korea University Anam Hospital
Seoul, 02841
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Seoul St Mary's Hospital
Seoul, 06591
- Recruiting
Boramae Medical Center
Seoul, 07061
- Recruiting
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
France6 sites, 6 recruiting
- Recruiting
Hopital Edouard Herriot - CHU Lyon
Lyon, 69003
- Recruiting
Clinique Honore Cave
Montauban, 82000
- Recruiting
Institut Ophtalmologique De l Ouest Jules Verne
Nantes, Paris, 44300
- Recruiting
CHNO des Quinze Vingts
Paris, 75012
- Recruiting
CHU Poitiers - CHR La Miletrie
Poitiers, 86021
- Recruiting
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091
Germany6 sites, 6 recruiting
- Recruiting
Klinikum Chemnitz gGmbH
Chemnitz, 09116
- Recruiting
Universitätkslinikum Düsseldorf, Augenklinik
Düsseldorf, 40225
- Recruiting
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, 37075
- Recruiting
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, 30625
- Recruiting
Universitätsmedizin Rostock
Rostock, 18057
- Recruiting
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Würzburg, 97080
Italy6 sites, 6 recruiting
- Recruiting
Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna, Sede Ospedale di Cona;UO di Clinica Oculistica
Cona (Ferrara), Emilia-Romagna, 44122
- Recruiting
ASST SANTI PAOLO E CARLO - Presidio San Paolo;SC Oculistica
Milan, Lombardy, 20142
- Recruiting
Ospedale Monaldi - AORN dei Colli
Naples, Campania, 80131
- Recruiting
Azienda Ospedaliero-Universitaria Ospedale Maggiore della Carità;S.C.D.U. Oftalmologia
Novara, Piedmont, 28100
- Recruiting
A.O.U. Policlinico Paolo Giaccone;Oculistica
Palermo, Sicily, 90142
- Recruiting
Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica
Rome, Lazio, 00186
Thailand5 sites, 5 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
- Recruiting
Rajavithi Hospital
Bangkok, 10400
- Recruiting
Ramathibodi Hospital
Bangkok, 10400
- Recruiting
Maharaj Nakorn ChiangMai Hospital
Chiang Mai, 50200
- Recruiting
Songklanagarind Hospital
Songkhla, 90110
Czechia4 sites, 4 recruiting
- Recruiting
Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt
Mladá Boleslav, 293 50
- Recruiting
Faculty Hospital Ostrava
Ostrava, 708 52
- Recruiting
Faculty Hospital Kralovske Vinohrady
Prague, 100 34
- Recruiting
Ustredni vojenska nemocnice
Prague, 169 02
Greece4 sites, 4 recruiting
- Recruiting
"G.Gennimatas" General Hospital of Athens
Athens, Attica, 115 27
- Recruiting
Attikon University General Hospital
Chaïdári, 124 62
- Recruiting
University General Hospital of Heraklion
Heraklon, 711 10
- Recruiting
University Hospital of Larissa
Larissa, 412 21
Austria3 sites, 3 recruiting
- Recruiting
Medizinische Universität Innsbruck
Innsbruck, 6020
- Recruiting
Kepler Universitätskliniken GmbH - Med Campus III
Linz, 4021
- Recruiting
Landesklinikum Mistelbach
Mistelbach, 2130
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
- Recruiting
Hospital Arnau de Vilanova (Valencia)
Valencia, 46015
Switzerland3 sites, 3 recruiting
- Recruiting
Berner Augenklinik
Bern, 3007
- Recruiting
Pallas Klinik Olten
Olten, 4600
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen, 9007
United Kingdom3 sites, 3 recruiting
- Recruiting
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
- Recruiting
Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW
- Recruiting
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus Universitetshospital
Aarhus N, 8200
- Recruiting
Rigshospitalet Glostrup
Glostrup Municipality, 2600
About this study
Official title: A Phase IIIb, Multicenter, Single-arm Study Assessing the Effectiveness, Safety and Patient Reported Outcomes of a 36-week Refill Exchange Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration
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.
- Being tested
- Susvimo PDS Implant, Ranibizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Susvimo PDS ImplantDevice
Also called RO4893594
Ranizumab will be administered via a PDS implant per the schedule described in the arm.
RanibizumabDrug
Also called RO4893594
Participants will receive ranibizumab delivered through the PDS implant.
Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.
| Study group | Role | What they receive |
|---|---|---|
| Port Delivery System (PDS) | Experimental | Participants will have the PDS implant (pre-filled with 100 mg/mL of ranibizumab) [approximately 2-milligrams (mg) dose] surgically inserted in the study eye on Day 1. Participants who meet the disease activity criteria (DAC) at Week 24 or receive supplemental treatment with intravitreal (IVT) injections of ranibizumab prior to Week 24 will receive implant refill exchanges every 24 weeks (Q24W). Participants who do not meet the DAC at Week 24 and have not received supplemental treatment will receive PDS refill exchanges Q36W. Receives: Device: Susvimo PDS Implant; Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Week 68, Week 72
Secondary outcomes (14)
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.
Measured: 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.
Measured: From baseline up to Week 72
Change From Baseline in Center Point Thickness (CPT)
Measured: From baseline up to Week 72
Change From Baseline in Central Subfield Thickness (CST)
Measured: From baseline up to Week 72
Proportion of Participants Who do not Undergo Supplemental Treatment With IVT Ranibizumab Before Each Refill-exchange Procedure
Measured: Up to Week 72
Number of Supplemental Treatments Participants Received in Each Refill Cycle
Measured: Up to Week 72
Frequency of Study Visits in Each Refill Cycle
Measured: 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) After First Refill (Week 24 or Week 36, Depending on Cohort) and at Week 72
Measured: Weeks 24, 36 and 72
Proportion of Participants With Bilateral Disease Who Report Preferring PDS Compared With IVT Ranibizumab Treatment Measured by the PPPQ After First Refill (Week 24 or Week 36, Depending on Cohort) and at Week 72
Measured: Weeks 24, 36 and 72
Number of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs)
Measured: Up to approximately 19 months
Number of Participants With Adverse Events of Special Interests (AESIs) and their Severity, Including Ocular AESIs
Measured: Up to approximately 19 months
Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Post-operative and Follow-up Period
Measured: 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
Measured: Up to approximately 19 months
Number of Participants With Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs With PDS
Measured: Up to approximately 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start27 Nov 2025
- Primary completion15 Nov 2028 (estimated)
- Study completion15 Nov 2028 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a Phase 3b study.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847542
- Sponsor's protocol ID
- MR45625
- Other IDs
- 2024-516924-32-00
- Acronym
- Sightspire
- Status last verified
- Oct 2026
- First submitted
- 21 Feb 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing