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Port Delivery System with ranibizumab refilled every 36 weeks for neovascular (wet) AMD

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

Phase 3 Interventional Hoffmann-La Roche · NCT06847542

This trial tests whether a refillable eye implant that delivers ranibizumab every 36 weeks works and is safe for people with recent neovascular (wet) age-related macular degeneration who responded to prior anti-VEGF injections.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment250 (estimated)
Ages50 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsranibizumab, brolucizumab
Locations56 sites (Innsbruck and 55 other locations)
Trial IDNCT06847542 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial uses the Susvimo port delivery system (PDS) implanted in the eye and filled with ranibizumab 100 mg/mL, with planned refill exchanges every 36 weeks. Participants must have been diagnosed with nAMD within the past 24 months, have received at least three prior anti-VEGF intravitreal injections with demonstrated response, and have baseline visual acuity of 34 ETDRS letters or better. The study will collect measures of effectiveness, safety, and patient-reported outcomes over the treatment period and will require regular clinic visits for implant procedures, refills, and imaging. Key exclusions include prior vitrectomy, prior intraocular device implantation, or prior intraocular corticosteroid injection in the study eye.

Who should consider this trial

Good fit: Ideal candidates are people with neovascular AMD diagnosed within 24 months who have shown a response to prior anti-VEGF injections, have available historical OCT and visual acuity data, and meet the minimum visual acuity criteria.

Not a fit: Patients with a history of vitrectomy, prior intraocular devices, prior intraocular corticosteroid injections, or those who did not respond to anti-VEGF therapy are less likely to benefit from this implant approach.

Why it matters

Potential benefit: If successful, the implant could substantially reduce injection frequency and clinic visits by providing longer-term drug delivery while maintaining vision.

How similar studies have performed: Previous PDS trials (for example earlier Phase 3 programs) have shown that ranibizumab delivered via an implant can maintain vision with fewer clinic visits, although device-related complications have also been reported.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Innsbruck and 55 other locations

+6 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neovascular Age-related Macular Degeneration
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.