Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

Part of paid clinical trials in Glendale, California.

Sponsor
Jaeb Center for Health Research
Study ID
NCT05904028
Phase
PHASE3
Status
Recruiting

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule — DRUG
    Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
  • Intravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule — DEVICE
    Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule

Study Details

Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.

Key Dates

Start date
Nov 9, 2023
Status verified
May 2025
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treat and Extend
    Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
  • Experimental: Home optical coherence tomography-Guided Treatment
    Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule

Primary Outcome Measure

E-ETDRS Change in Visual Acuity Letter Score [ Time Frame: Baseline to 104 weeks ]

Locations (63)

FacilityCityStateZIPSite coordinators
Kent W. Small, MD, AMCGlendaleCalifornia91203-1971
Kent W Small, MD, AMC
818-552-5040
Loma Linda UniversityLoma LindaCalifornia92354
David I. Sierpina, MD
909-558-2169
East Bay Retina Consultants, Inc.OaklandCalifornia94609
Soraya Rofagha
510-444-1600
Kaiser Permanente - OaklandOaklandCalifornia94611
Amar Patel
5107526198
Southern California Desert Retina Consultants, Inc.Palm DesertCalifornia92211
Clement K. Chan, MD, FACS
(760) 340-2394
UC Davis Health Eye CenterSacramentoCalifornia95817
Ala Moshiri, MD, PhD
916-734-6074
Macula Retina Vitreous InstituteTorranceCalifornia90503
Mehran Taban, MD
4242479090
Bay Area Retina Associates A Medical GroupWalnut CreekCalifornia94598
Yingna S. Liu, MD
9252654146
Retina ConsultantsManchesterConnecticut06042
Noam Rudnick, MD, PhD
2036458430
National Ophthalmic Research InstituteFort MyersFlorida33912
A. T Ghuman, MD
239-939-4323
National Ophthalmic Research InstituteFort MyersFlorida33912
A. T. Ghuman, MD
239-939-4323
Florida Retina Institute, James A. Staman, MD, PA- JacksonvilleJacksonvilleFlorida32216
Benjamin J. Thomas, MD
904-997-9202
University of Florida- JacksonvilleJacksonvilleFlorida32209
Sandeep Grover, MD
(904) 244-9361
Argus Research Center, IncNaplesFlorida34105
Marilyn A. Marquez, MD
2395422020
Southeast Eye Institute, P.A. dba Eye Associates of PinellasPinellas ParkFlorida33782-4418
Jason M. Handza, DO
727-541-4469
Retina Associates of SarasotaSarasotaFlorida34233
Elizabeth R Richter, MD, PhD
941-924-0303
Sarasota Retina InstituteSarasotaFlorida34239
Marc H Levy, MD, FACS
941-921-5335
Retina Associates of Florida, LLCTampaFlorida33609
Marc C Peden, MD
813-875-6373
Southeast Retina Center, P.C.AugustaGeorgia30909
Dennis Marcus
706-650-0061
Thomas Eye GroupSandy SpringsGeorgia30328
Paul L. Kaufman, MD
404-256-1507
Northwestern Memorial GroupChicagoIllinois60611
Rukhsana Mirza, MD, MS
312-695-2567
Rush University Medical CenterChicagoIllinois60612
Mathew W. MacCumber, MD, PhD
312-942-2117
UIC - Dept of Ophthalmology & Visual SciencesChicagoIllinois60612
Jennifer I. Lim, MD
(312) 355-3743
Midwest Eye InstituteIndianapolisIndiana46290
Raj K. Maturi, MD
317-817-1414
The Trustees of Indiana UniversityIndianapolisIndiana46202
Denis Jusufbegovic, MD
317-944-2020
Wolfe Clinic, P.C.- West Des MoinesWest Des MoinesIowa50266
Jared S. Nielsen, MD, MS, MBA
515-223-8685
Mid-America Retina Consultants, P.A.Overland ParkKansas66211
William N. Rosenthal, MD
(913) 663-5900
University of Kentucky Advanced Eye CareLexingtonKentucky40508
Michelle Abou-Jaoude, MD
8595623570
Elman Retina Group, BABaltimoreMaryland21237
Michael J Elman, MD
410-686-3394
Johns Hopkins UniversityBaltimoreMaryland21287
Sharon D. Solomon, MD
410-614-6908
Valley Eye Physicians and SurgeonsAyerMassachusetts01432
Gisela Velez, MD, MPH, MA
978-772-4000
Joslin Diabetes CenterBostonMassachusetts02215
Lloyd P Aiello, MD, PhD
614-309-2520
Henry Ford Health SystemDetroitMichigan48202
Paul A. Edwards, MD
313-874-9167
Retina Associates of MichiganGrand BlancMichigan48439
Raafay Sophie, MD
8104874500
Associated Retinal Consultants, P.C.Royal OakMichigan48073
Matthew G. Trese, DO
2482889132
Associated Retinal ConsultantsTraverse CityMichigan49686
Diane K. Fiander, MD
231-938-0710
The Retina InstituteSt LouisMissouri63128
Kevin Blinder
314-367-1181
Associated Retinal Surgeons d/b/a Mid Atlantic RetinaCherry HillNew Jersey08034
Jason Hsu, MD
2159283092
Macula CareNew YorkNew York10021
Daniel F. Rosberger, MD, PhD, MPH
212-439-9600
New York University Langone HealthNew YorkNew York10017
Vaidehi Dedania
9294555522
Vitreous Retina Macula Consultants of NY - VRMNYNew YorkNew York10022
Irene Barbazetto, MD
2128619797
Retina Associates of Western NY, P.C.RochesterNew York14620
Edward F. Hall, MD
585-442-3411
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of MedicineClevelandOhio44120
Aleksandra V. Rachitskaya, MD
216-445-9519
Retina Vitreous CenterEdmondOklahoma73013
Michael P. Hood, MD
(405) 607-6699
Verum Research LLCEugeneOregon97401
Albert O. Edwards, MD, PhD
541-762-2763
Oregon Health & Science UniversityPortlandOregon97239
Merina Thomas, MD
503-494-3055
Cascade Medical Research Institute, LLCSpringfieldOregon97477
John W. Karth, MD
541-687-1927
Retina Vitreous ConsultantsMonroevillePennsylvania15146
Karl R Olsen, MD
412-683-5300
The Trustees of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Alexander J. Brucker, MD
215-662-9702
Hilton Head Retina InstituteHilton Head IslandSouth Carolina29926
Carl W. Baker, MD
8437152424
Ophthalmology Ltd.Sioux FallsSouth Dakota57108
Elizabeth A. Atchison, MD
6053366294
Southeastern Retina AssociatesHixsonTennessee37343
Francis C. DeCroos, MD
423-756-1002
Southeastern Retina Associates, P.C.KnoxvilleTennessee37922
R. K. Shuler, Jr., MD
865-588-0811
Austin Research Center for RetinaAustinTexas78705
Chirag Jhaveri, MD
737-704-0130
Retina Consultants of Texas, PABellaireTexas77401
Charles C. Wykoff, MD, PhD
713-524-3434
UT Southwestern Medical CenterDallasTexas75390
Judy E. Kim, MD
214-645-2012
Southwest Retina ConsultantsEl PasoTexas79902
Richard Y Hwang, MD
9155323912
Baylor College of Medicine, Baylor Eye Physicians and SurgeonsHoustonTexas77030-4101
Christina Y. Weng, MD, MBA
713-798-3493
Texas Retina AssociatesLubbockTexas79424
Michel Shami, MD
806-792-0066
Retina Associates of South TexasSan AntonioTexas78240
Juan E. Rubio, MD
2106157600
Retinal Consultants of TexasSan AntonioTexas78240
Moises A. Chica, MD
210-615-1311
The Board of Regents of the University of Wisconsin SystemMadisonWisconsin53705
Kathleen Schildroth
608-263-7290
Eye Clinic of WisconsinWausauWisconsin54403
Deepak Sambhara, MD
8002618500

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