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Macular DegenerationPhase 1/2BURGUNDYNCT04567303

Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration

A Phase 1/2 study testing Zifibancimig, Ranibizumab and Port Delivery Platform in people with Macular Degeneration, run by Hoffmann-La Roche at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a first in-human study to investigate the safety, tolerability and efficacy of zifibancimig administered through intravitreal (IVT) injections and via the port delivery (PD) implant in participants with neovascular age-related macular degeneration (nAMD). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Zifibancimig, Ranibizumab and Port Delivery Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
37 sitesin 2 countries
Study dates
28 Oct 2020to 25 Aug 2026
Phase
Phase 1/2
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

  • Willing to allow AH collection
  • Part 1 and Part 2
  • Ocular Inclusion Criteria for Study Eye:
  • Choroidal neovascularization (CNV) exclusively due to age-related macular degeneration (AMD)
  • Anti-vascular endothelial growth factor (VEGF) or anti-VEGF/Angiopoietin-2 (Ang-2) IVT treatment-naïve, or pre-treated with anti-VEGF or anti-VEGF/Ang-2 no less than two months prior to Day 1
  • Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), fundus autofluorescence (FAF), and spectral domain optical coherence tomography (SD-OCT) images
Show all 33Show fewer
  • Decreased BCVA attributable primarily to nAMD, with BCVA letter score of 78 to 34 letters (inclusive) on ETDRS-like charts at screening. In case both eyes of a participant are eligible, the eye with the lower BCVA score should become the study eye
  • Part 3
  • Ocular Inclusion Criteria for Study Eye:
  • CNV exclusively due to AMD
  • Diagnosis of nAMD within 36 months prior to the screening visit
  • Previous treatment with at least one IVT anti-VEGF or anti-VEGF/Ang-2 administrations IVT for nAMD. The last IVT administration must have occurred at least 21 days prior to the screening visit
  • Demonstrated response to prior IVT anti-VEGF or anti-VEGF/Ang-2 treatment since diagnosis
  • Availability of historical VA data prior to the first anti-VEGF or anti-VEGF/Ang-2 treatment for nAMD
  • Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading
  • Decreased BCVA attributable primarily to nAMD with letter score of 78 to 34 letters (inclusive) or better on ETDRS-like charts
  • Ocular Exclusion Criteria for Study Eye:
  • History of vitrectomy surgery, submacular surgery, other intraocular surgery, or any planned surgical intervention during the study period
  • Cataract surgery without complications within three months preceding the screening visit or planned during the study period
  • 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 laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
  • Prior macular treatment with verteporfin, external beam radiation therapy, transpupillary thermotherapy, or any type of laser photocoagulation
  • Prior treatment with IVT corticosteroids or implant (e.g., triamcinolone, ozurdex, iluvien)
  • Subretinal hemorrhage >50% of the total lesion area and/or involving the fovea
  • Subfoveal fibrosis or subfoveal atrophy
  • Retinal pigment epithelial tear involving the macula
  • History of vitreous hemorrhage, rhegmatogenous retinal detachment, glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery, and corneal transplant
  • History of rhegmatogenous retinal tears or peripheral retinal breaks within three months prior to the screening visit
  • Actual or history of myopia >-8 diopters
  • Uncontrolled ocular hypertension or glaucoma (defined as intraocular pressure [IOP] >25 millimeters of mercury (mm Hg) or a cup to disc ratio >0.8, despite treatment with antiglaucoma medication) and any such condition the Investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study
  • Concurrent intraocular conditions (e.g., cataract, diabetic retinopathy, epiretinal membrane with traction, macular hole) that, in the opinion of the Investigator, could either: require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition; or likely contribute to loss of BCVA over the study period if allowed to progress untreated; or preclude any visual improvement due to substantial structural damage
  • 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 PD implant
  • Prior treatment with any medication for geographic atrophy (GA) during the last 3 months prior to screening
  • Prior treatment with any anti-VEGF-C or anti-VEGF-D inhibitors

Who cannot join

  • BCVA letter score using ETDRS charts of < 34 letters
  • Treatment with IVT anti-VEGF or anti-VEGF/Ang-2 agents within one week prior to Day 1 (concurrent treatment with SUSVIMO^TM in the fellow eye is not exclusionary)
  • CNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, uveitis or central serous chorioretinopathy
  • Prior participation in a clinical trial involving anti-VEGF drugs within six months prior to the screening visit, other than ranibizumab, aflibercept, or faricimab including approved biosimilars
  • Active intraocular inflammation (grade trace or above), infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
  • History of uveitis, including history of any intraocular inflammation following intravitreal therapy
  • Prior treatment with brolucizumab
  • Prior gene therapy for nAMD

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States36 sites

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • Johns Hopkins Med

    Baltimore, Maryland, 21287

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • OSU Eye Physicians & Surgeons

    Columbus, Ohio, 43212

  • Southwest Retina Consultants

    Durango, Colorado, 81303

  • Duke Eye Center

    Durham, North Carolina, 27705

  • The Retina Partners

    Encino, California, 91436

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Graystone Eye

    Hickory, North Carolina, 28602

  • Retina Consultants of Texas

    Houston, Texas, 77030

  • Southeastern Retina Associates

    Knoxville, Tennessee, 37922

  • Retina Vit Surgeons/Central NY

    Liverpool, New York, 13088

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona, 85206

  • Carolina Eyecare Physicians

    Mt. Pleasant, South Carolina, 29464

  • Tennessee Retina PC.

    Nashville, Tennessee, 37203

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • Mid Atlantic Retina - Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Maine Eye Center

    Portland, Maine, 04101

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Associated Retinal Consultants

    Royal Oak, Michigan, 48073

  • Retinal Consultants Med Group

    Sacramento, California, 95841

  • VitreoRetinal Surgery, PLLC.

    Saint Louis Park, Minnesota, 55416

  • Orange County Retina Med Group

    Santa Ana, California, 92705

  • Retina Center of Texas

    Southlake, Texas, 76092

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • The Retina Institute

    St Louis, Missouri, 63128

  • Retina Vitreous Assoc of FL

    St. Petersburg, Florida, 33711

  • Southern Vitreoretinal Assoc

    Tallahassee, Florida, 32308

Other trials in United States

Puerto Rico1 site

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612

Other trials in Puerto Rico

About this study

Official title: A Three-part, Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Zifibancimig Following Intravitreal Administration of Multiple Ascending Doses and Continuous Delivery From the Port Delivery in Patients With Neovascular Age-related Macular Degeneration

This is a first in-human study to investigate the safety, tolerability and efficacy of zifibancimig administered through intravitreal (IVT) injections and via the port delivery (PD) implant in participants with neovascular age-related macular degeneration (nAMD).

Being tested
Zifibancimig, Ranibizumab, Port Delivery Platform
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZifibancimigDrug

    Also called RO7250284

    Part 1: multiple ascending doses by IVT injection. Each participant will receive zifibancimig at a constant volume of 50 microliter (µL) in the study eye.

    Part 2: participants will be randomized to one of two dose levels of zifibancimig in the PD implant.

    Part 3: Participants will receive one of the two dose levels of zifibancimig in the PD implant.

  • RanibizumabDrug

    Participants will receive ranibizumab 100 mg/mL through the PD implant

  • Port Delivery PlatformDevice

    Participants will receive intraocular refillable device that is surgically inserted into the eye for continuous delivery of drugs into the vitreous.

Study groups in NCT04567303
Study groupRoleWhat they receive
Part 1: IVT InjectionsExperimentalZifibancimig administered in multiple ascending dose levels through IVT injections.
Receives: Drug: Zifibancimig
Part 2: PD With High DoseExperimentalZifibancimig administered at a high dose through the PD implant, followed by ranibizumab, 100 milligrams per milliliter (mg/mL), administered through the PD implant.
Receives: Drug: Zifibancimig; Drug: Ranibizumab; Device: Port Delivery Platform
Part 2: PD With Low DoseExperimentalZifibancimig administered at a low dose through the PD implant, followed by ranibizumab, 100 mg/mL, administered through the PD implant.
Receives: Drug: Zifibancimig; Drug: Ranibizumab; Device: Port Delivery Platform
Part 3: PD With High DoseExperimentalZifibancimig administered at a high dose through the PD implant, followed by ranibizumab, 100 mg/mL, administered through PD implant.
Receives: Drug: Zifibancimig; Drug: Ranibizumab; Device: Port Delivery Platform
Part 3: PD With Low DoseExperimentalZifibancimig administered at a low dose through the PD implant, followed by ranibizumab, 100 mg/mL, administered through PD implant.
Receives: Drug: Zifibancimig; Drug: Ranibizumab; Device: Port Delivery Platform
Part 3: PD With RanibizumabActive comparator100 mg/mL of ranibizumab administered through the PD implant.
Receives: Drug: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs)

    Measured: Part 1: Baseline up to Week 24; Parts 2 & 3: Baseline up to Week 48

  2. Percentage of Participants With Ocular AEs During the Post-operative and Follow-up Periods

    Measured: Parts 2 and 3: From Day 1 to Week 4 and during follow-up period (up to Week 48)

  3. Percentage of Participants With Adverse Events of Special Interest (AESIs) Including Ocular AESIs

    Measured: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 48

  4. Percentage of Participants With Ocular AESIs During the Post-operative and Follow-up Periods

    Measured: Parts 2 and 3: From Day 1 to Week 4 and during follow-up period (up to Week 48)

  5. Duration of Ocular AESIs

    Measured: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 48

  6. Duration of Ocular AESIs During the Post-operative and Follow-up Periods

    Measured: Parts 2 and 3: From Day 1 to Week 4 and during follow-up period (up to Week 48)

  7. Percentage of Participants With Adverse Device Effects (ADEs)

    Measured: Parts 2 and 3: Baseline up to Week 48

  8. Duration of ADEs

    Measured: Parts 2 and 3: Baseline up to Week 48

  9. Percentage of Participants With Anticipated Serious ADEs (ASADEs)

    Measured: Parts 2 and 3: Baseline up to Week 48

  10. Duration of ASADEs

    Measured: Parts 2 and 3: Baseline up to Week 48

  11. Change From Baseline in Early Treatment Diabetic Retinopathy Study - Best Corrected Visual Acuity (ETDRS-BCVA) Score at Week 48

    ETDRS-BCVA will be used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

    Measured: Part 3: Baseline (baseline visit, before implant insertion), and Week 48

Secondary outcomes (8)

  1. Maximum Observed Concentration (Cmax) of Zifibancimig in Blood and Aqueous Humor (AH)

    Measured: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 144

  2. Time of Maximum Concentration Observed (Tmax) of Zifibancimig in Blood and AH

    Measured: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 144

  3. Concentration at the End of a Dosing Interval Before the Next Dose Administration (Ctrough) of Zifibancimig in Blood and AH

    Measured: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 144

  4. Area Under the Curve (AUC) of Zifibancimig in Blood and AH

    Measured: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 144

  5. Percentage of Participants Who did not Meet Supplemental Treatment Criteria for the PD Implant With Zifibancimig

    Measured: Part 3: Week 36, Week 40, and Week 44

  6. Percentage of Participants Who Gained or Lost ≥15, ≥10 ≥5 or ≥0 Letters in ETDRS-BCVA Score From Baseline to Week 48

    ETDRS-BCVA will be used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

    Measured: Part 3: Baseline to Week 48

  7. Change From Baseline in Central Subfield Thickness (CST) at Week 48

    Measured: Part 3: Baseline, and Week 48

  8. Change From Baseline Over Time in CST

    Measured: Part 3: Baseline to end of follow-up period (up to Week 144)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2020
  2. Study start28 Oct 2020
  3. Primary completion25 Aug 2026
  4. Study completion25 Aug 2026

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part 1 of the study will be an open-label multiple ascending dose (MAD) study, followed by subsequent assignment to 2 groups in Part 2. Part 3 will enroll new participants to compare the efficacy of zifibancimig PD implant versus ranibizumab released via the PD implant.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04567303
Sponsor's protocol ID
BP41670
Acronym
BURGUNDY
Status last verified
Sep 2026
First submitted
24 Sep 2020
Last updated
14 Sep 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Zifibancimig, Ranibizumab and Port Delivery Platform in people with Macular Degeneration, run by Hoffmann-La Roche at 37 sites in 2 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 33 inclusion and 8 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Puerto Rico. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs) (time frame: Part 1: Baseline up to Week 24; Parts 2 & 3: Baseline up to Week 48). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04567303.

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 14 Sep 2026.

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