A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD (Sightspire)

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.

Study Overview

• Status: Recruiting
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Device: Susvimo PDS Implant; Drug: Ranibizumab

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: MR45625 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S.); Email: global-roche-genentech-trials@gene.com

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medizinische Universität Innsbruck
  • Linz, Austria, 4021
    • Recruiting
    • Kepler Universitätskliniken GmbH - Med Campus III
  • Mistelbach, Austria, 2130
    • Recruiting
    • Landesklinikum Mistelbach
• Czechia
  • Mladá Boleslav, Czechia, 293 50
    • Recruiting
    • Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt
  • Ostrava, Czechia, 708 52
    • Recruiting
    • Faculty Hospital Ostrava
• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Aarhus Universitetshospital
  • Glostrup Municipality, Denmark, 2600
    • Recruiting
    • Rigshospitalet Glostrup
• France
  • Lyon, France, 69003
    • Recruiting
    • Hopital Edouard Herriot - CHU Lyon
  • Montauban, France, 82000
    • Recruiting
    • Clinique Honore Cave
  • Paris, France, 75012
    • Recruiting
    • CHNO des Quinze Vingts
  • Poitiers, France, 86021
    • Recruiting
    • CHU Poitiers - CHR La Miletrie
  • Strasbourg, France, 67091
    • Recruiting
    • CHU Strasbourg - Nouvel Hopital Civil
  • Paris
    • Nantes, Paris, France, 44300
      • Recruiting
      • Institut Ophtalmologique De l Ouest Jules Verne
• Germany
  • Chemnitz, Germany, 09116
    • Recruiting
    • Klinikum Chemnitz gGmbH
  • Düsseldorf, Germany, 40225
    • Recruiting
    • Universitätkslinikum Düsseldorf, Augenklinik
  • Göttingen, Germany, 37075
    • Recruiting
    • Universitätsmedizin Göttingen Georg-August-Universität
  • Hanover, Germany, 30625
    • Recruiting
    • Medizinische Hochschule Hannover, Klinik für Augenheilkunde
  • Rostock, Germany, 18057
    • Recruiting
    • Universitätsmedizin Rostock
  • Würzburg, Germany, 97080
    • Recruiting
    • Universitätsklinikum Würzburg, Augenklinik und Poliklinik
• Greece
  • Chaïdári, Greece, 124 62
    • Recruiting
    • Attikon University General Hospital
  • Heraklon, Greece, 711 10
    • Recruiting
    • University General Hospital of Heraklion
  • Larissa, Greece, 412 21
    • Recruiting
    • University Hospital of Larissa
  • Attica
    • Athens, Attica, Greece, 115 27
      • Recruiting
      • "G.Gennimatas" General Hospital of Athens
• Italy
  • Campania
    • Naples, Campania, Italy, 80131
      • Recruiting
      • Ospedale Monaldi - AORN dei Colli
  • Emilia-Romagna
    • Cona (Ferrara), Emilia-Romagna, Italy, 44122
      • Recruiting
      • Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna, Sede Ospedale di Cona;UO di Clinica Oculistica
  • Lazio
    • Rome, Lazio, Italy, 00186
      • Recruiting
      • Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica
  • Lombardy
    • Milan, Lombardy, Italy, 20142
      • Recruiting
      • ASST SANTI PAOLO E CARLO - Presidio San Paolo;SC Oculistica
  • Piedmont
    • Novara, Piedmont, Italy, 28100
      • Recruiting
      • Azienda Ospedaliero-Universitaria Ospedale Maggiore della Carità;S.C.D.U. Oftalmologia
  • Sicily
    • Palermo, Sicily, Italy, 90142
      • Recruiting
      • A.O.U. Policlinico Paolo Giaccone;Oculistica
• Poland
  • Bielsko-Biala, Poland, 43-309
    • Recruiting
    • Szpital sw. Lukasza
  • Bydgoszcz, Poland, 85-631
    • Recruiting
    • OFTALMIKA Sp. z o.o
  • Bydgoszcz, Poland, 85-316
    • Recruiting
    • Specjalistyczny O?rodek Okulistyczny Oculomedica
  • Gliwice, Poland, 44-100
    • Recruiting
    • Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
  • Lublin, Poland, 20-079
    • Recruiting
    • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie;Klinika Chirurgii Siatkówki i Cia?a Szklistego
  • Lódz, Poland, 91-134
    • Recruiting
    • Klinika Okulistyczna Jasne Błonia Sp. z o. o.
  • Olsztyn, Poland, 10-424
    • Recruiting
    • Centrum Diagnostyki i Mikrochirurgii Oka LENS
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31 416
      • Recruiting
      • MW-med
• South Korea
  • Daegu, South Korea, 41944
    • Recruiting
    • Kyungpook National University Hospital
  • Gyeonggi-do, South Korea, 16499
    • Recruiting
    • Ajou University Medical Center
  • Seoul, South Korea, 03722
    • Recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 02841
    • Recruiting
    • Korea University Anam Hospital
  • Seoul, South Korea, 06591
    • Recruiting
    • Seoul St Mary's Hospital
  • Seoul, South Korea, 07441
    • Recruiting
    • Hallym University Kangnam Sacred Heart Hospital
  • Seoul, South Korea, 07061
    • Recruiting
    • Boramae Medical Center
• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46015
    • Recruiting
    • Hospital Arnau de Vilanova (Valencia)
• Switzerland
  • Bern, Switzerland, 3007
    • Recruiting
    • Berner Augenklinik
  • Olten, Switzerland, 4600
    • Recruiting
    • Pallas Klinik Olten
  • Sankt Gallen, Switzerland, 9007
    • Recruiting
    • Kantonsspital St. Gallen
• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10400
    • Recruiting
    • Rajavithi Hospital
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Maharaj Nakorn Chiangmai Hospital
  • Songkhla, Thailand, 90110
    • Recruiting
    • Songklanagarind Hospital
• United Kingdom
  • Gloucester, United Kingdom, GL1 3NN
    • Recruiting
    • Gloucestershire Royal Hospital
  • London, United Kingdom, EC1V 2PD
    • Recruiting
    • Moorfields Eye Hospital NHS Foundation Trust
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE1 5WW
      • Recruiting
      • Leicester Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

A. 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
• 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

B. 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

C. 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

D. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Port Delivery System (PDS); 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.

Device: Susvimo PDS Implant; Ranizumab will be administered via a PDS implant per the schedule described in the arm.; Other Names: RO4893594; Drug: Ranibizumab; Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.; Other Names: RO4893594

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Week 68, Week 72

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From baseline up to Week 72
Change From Baseline in Center Point Thickness (CPT)		From baseline up to Week 72
Change From Baseline in Central Subfield Thickness (CST)		From baseline up to Week 72
Proportion of Participants Who do not Undergo Supplemental Treatment With IVT Ranibizumab Before Each Refill-exchange Procedure		Up to Week 72
Number of Supplemental Treatments Participants Received in Each Refill Cycle		Up to Week 72
Frequency of Study Visits in Each Refill Cycle		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) at Weeks 24 and 72		Weeks 24 and 72
Proportion of Participants With Bilateral Disease Who Report Preferring PDS Compared With IVT Ranibizumab Treatment Measured by the PPPQ at Weeks 24 and 72		Weeks 24 and 72
Number of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs)		Up to approximately 19 months
Number of Participants With Adverse Events of Special Interests (AESIs) and their Severity, Including Ocular AESIs		Up to approximately 19 months
Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Post-operative and Follow-up Period		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		Up to approximately 19 months
Number of Participants With Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs With PDS		Up to approximately 19 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2025
• Primary Completion (Estimated): November 15, 2028
• Study Completion (Estimated): November 15, 2028

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Wet Macular Degeneration; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ranibizumab
• Other Study ID Numbers: MR45625; 2024-516924-32-00 (Ctis: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes