A Phase 3 interventional study of Susvimo PDS Implant and Ranibizumab in Neovascular Age-related Macular Degeneration, sponsored by Hoffmann-La Roche. Recruiting at 64 sites in 13 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's planned enrollment of 250 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A. Prior Ocular Treatment
Study Eye:
Either Eye:
B. Macular Neovascularization/Choroidal Neovascularization (MNV/CNV) Lesion Characteristics:
Study Eye:
Either Eye:
C. Concurrent Ocular Conditions:
Study Eye:
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:
D. Concurrent Systemic Conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Ranibizumab
Ranizumab will be administered via a PDS implant per the schedule described in the arm.
Also known as: RO4893594
Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.
Also known as: RO4893594
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).
Time frame: Baseline, Week 68, Week 72
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.
Time frame: 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.
Time frame: From baseline up to Week 72
Change From Baseline in Center Point Thickness (CPT)
Time frame: From baseline up to Week 72
Change From Baseline in Central Subfield Thickness (CST)
Time frame: From baseline up to Week 72
Proportion of Participants Who do not Undergo Supplemental Treatment With IVT Ranibizumab Before Each Refill-exchange Procedure
Time frame: Up to Week 72
Number of Supplemental Treatments Participants Received in Each Refill Cycle
Time frame: Up to Week 72
Frequency of Study Visits in Each Refill Cycle
Time frame: 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
Time frame: 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
Time frame: Weeks 24, 36 and 72
Number of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs)
Time frame: Up to approximately 19 months
Number of Participants With Adverse Events of Special Interests (AESIs) and their Severity, Including Ocular AESIs
Time frame: Up to approximately 19 months
Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Post-operative and Follow-up Period
Time frame: 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
Time frame: Up to approximately 19 months
Number of Participants With Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs With PDS
Time frame: Up to approximately 19 months
Not enrolling at this site — choose another above.
Plan to share: 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
Started Nov 2025 (actual). Primary completion is estimated for Nov 2028, 35 months after the start.
Of 77 industry-sponsored phase 3 interventional studies under Macular Degeneration, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 33. This study's planned 35 months is above that.
Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 20 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ranibizumab