A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT04853251
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PDS Implant With Ranibizumab 100 mg/ml — DEVICE
    Ranibizumab 100 mg/mL will be delivered via PDS
  • LUCENTIS (Ranibizumab Injection) — DRUG
    Ranibizumab (0.5 mg intravitreal \[IVT\] injections of 10 mg/mL formulation) will be used in the study eye as supplemental treatment. If a participant discontinues study treatment, he/she may start receiving IVT ranibizumab injections in the study eye, per investigator's discretion.

Study Details

This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).

Key Dates

Start date
Dec 14, 2021
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Oct 29, 2027

Study Design

Enrollment
188 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SUSVIMO
    Participants will have the PDS implant (filled prior to implantation with approximately 20 microlitres \[uL\] of the 100 milligrams/millilitres \[mg/ml\] formulation of ranibizumab \[approximately 2 milligrams (mg) dose of ranibizumab\]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed Q24W intervals.

Primary Outcome Measure

Percent Change in Corneal Endothelial Cell Density (ECD) From Baseline at Week 48 in the Study Eye as Compared With the Fellow Eye, as Assessed by Specular Microscopy [ Time Frame: Baseline, Week 48 ]

Central Contacts

  • Reference Study ID Number: ML43000 https://forpatients.roche.com/
    888-662-6728 (U.S.)
    [email protected]

Locations (50)

FacilityCityStateZIPSite coordinators
Barnet Dulaney Perkins Eye CenterMesaArizona85206-2747-
California Retina ConsultantsBakersfieldCalifornia93309-
Retina Associates of Southern CaliforniaHuntington BeachCalifornia92647-
California Eye Specialists Medical group Inc.PasadenaCalifornia91107-3747-
Retinal Consultants Med GroupSacramentoCalifornia95841-2013-
University of California San FranciscoSan FranciscoCalifornia94158-2510-
Orange County Retina Med GroupSanta AnaCalifornia92705-6504-
Macula Retina Vitreous Research InstituteTorranceCalifornia90503-3270-
Southwest Retina ConsultantsDurangoColorado81303-
Advanced Vision Research InstituteLongmontColorado80503-6499-
Retina Group of New EnglandWaterfordConnecticut06385-1215-
Retina Specialty InstitutePensacolaFlorida32503-2030-
Ft Lauderdale Eye InstitutePlantationFlorida33324-3118-
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33711-1141-
Southeast Retina CenterAugustaGeorgia30909-6440-
University Retina and Macula Associates, PCLemontIllinois60439-7421-
Wolfe Eye ClinicWest Des MoinesIowa50266-
Retina Associates of KentuckyLexingtonKentucky40509-1827-
Maine Eye CenterPortlandMaine04101-
The Retina Care CenterBaltimoreMaryland21209-2219-
Wilmer Eye Institute Johns Hopkins UniversityBaltimoreMaryland21287-0005-
Retina Group of WashingtonChevy ChaseMaryland20815-6956-
Cumberland Valley Retina Consultants PCHagerstownMaryland21740-
Associated Retinal Consultants PCRoyal OakMichigan48073-
VitreoRetinal Surgery, PLLC.MinneapolisMinnesota55435-3004-
Midwest Vision Research FoundationChesterfieldMissouri63017-5065-
Sierra Eye AssociatesRenoNevada89502-1605-
Envision Ocular, LLCBloomfieldNew Jersey07003-
Seeta Eye CentersPoughkeepsieNew York12603-2416-
Western Carolina Retinal Associate PAAshevilleNorth Carolina28803-2493-
Duke Eye CenterDurhamNorth Carolina27705-4699-
Fargo Retina ConsultantsFargoNorth Dakota58047-
Cincinnati Eye InstituteBlue AshOhio45242-5537-
Cleveland ClinicClevelandOhio44195-
Tulsa Retina ConsultantsTulsaOklahoma74114-
Erie Retina ResearchEriePennsylvania16505-
Mid Atlantic RetinaPhiladelphiaPennsylvania19107-5109-
Palmetto Retina CenterFlorenceSouth Carolina29501-
Palmetto Retina Center, LLCWest ColumbiaSouth Carolina29169-2429-
Charles Retina InstituteGermantownTennessee38138-2405-
Tennessee Retina PCNashvilleTennessee37203-1596-
Panhandle Eye Group LLP Southwest Retina SpecialistsAmarilloTexas79106-1835-
Austin Retina AssociatesAustinTexas78705-1169-
Retina Consultants of TexasBellaireTexas77401-
Retina Consultants of TexasSchertzTexas78154-
Retina Associates of Utah, PLLCSalt Lake CityUtah84107-6767-
Piedmont Eye CenterLynchburgVirginia24502-4271-
Wagner Kapoor InstituteNorfolkVirginia23502-3933-
Retina Institute of VirginiaRichmondVirginia23235-1962-
Spokane Eye Clinical ResearchSpokaneWashington99204-

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By research site
Barnet Dulaney Perkins Eye Center· Mesa, AZCalifornia Retina Consultants· Bakersfield, CARetina Associates of Southern California· Huntington Beach, CACalifornia Eye Specialists Medical group Inc.· Pasadena, CARetinal Consultants Med Group· Sacramento, CAUniversity of California San Francisco· San Francisco, CA

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