A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

NCT06635148 — Phase 2 / Phase 3, Recruiting, 274 participants, Janssen Research & Development, LLC

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Long-term Extension Study for Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies

RegistryNCT06635148
StatusRecruiting
PhasePhase 2 / Phase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment274 (Estimated)
SponsorJanssen Research & Development, LLC (Industry)
ConditionsGeographic Atrophy, Macular Degeneration
InterventionsJNJ-81201887, Sham Procedure (Drug, other)
Datesstart 2024-09-19, primary completion 2029-08-24 (estimated), completion 2030-07-16 (estimated), first posted 2024-10-10, last updated 2026-09-30
Locations104 sites in United States, Australia, Belgium, Canada, China, Czechia, Denmark, Germany and 10 more countries

Related Papers Related Patents Related Grants Related Experts
All trials for Geographic Atrophy All trials for Macular Degeneration All trials of JNJ-81201887 All trials of Sham Procedure

-Summary

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

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+Arms and interventions

ArmTypeInterventionsDescription
Arm A: JNJ-81201887 Low DoseExperimentalDrug: JNJ-81201887Study participants who were enrolled and received treatment with low dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this long-term extension (LTE) study. No study intervention will be administered as part of this study.
Arm B: JNJ-81201887 High doseExperimentalDrug: JNJ-81201887Study participants who were enrolled and received treatment with high dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this LTE study. No study intervention will be administered as part of this study.
Arm C: Sham ProcedureSham comparatorOther: Sham ProcedureParticipants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) will enter this LTE study. No intervention will be administered as part of this study.
  • JNJ-81201887 (Drug): No study intervention will be administered as part of this LTE study.
  • Sham Procedure (Other): No study intervention will be administered as part of this LTE study.

+Outcome measures

Primary outcomes

  • Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs) [Upto 5 Years]: Number of participants with ocular and systemic TEAEs will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any adverse event occurring at or after the administration of study intervention.
  • Number of Participants with Abnormal Findings in Clinical Laboratory Assessments [Upto 5 Years]: Number of participants with abnormal findings in clinical laboratory Assessments (including hematology and clinical chemistry) will be reported.
  • Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations [Upto 5 Years]: Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography) and eye examinations will be reported.
  • Change from Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score [Baseline up to 42 months]: BCVA will be assessed using the ETDRS chart at a starting distance of 4 meters. The ETDRS score ranges from 0 to 100 letters, where an increase in the number of letters read correctly means that visual acuity has improved and vice-versa.

+Eligibility

Sex: All, ages: 60 Years to any

Inclusion Criteria:

* Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003)
* Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contraception in this LTE study
* Must sign an informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations

Exclusion Criteria:

* There are no exclusion criteria for this LTE study

+Locations (104)

FacilityCityCountryStatus
Retina Associates Southwest PCTucson, ArizonaUnited StatesRecruiting
Retina Consultants of Orange CountyFullerton, CaliforniaUnited StatesRecruiting
Shiley Eye Institute Jacobs Retina CenterLa Jolla, CaliforniaUnited StatesRecruiting
California Retina ConsultantsOxnard, CaliforniaUnited StatesRecruiting
California Eye Medical SpecialistsPasadena, CaliforniaUnited StatesRecruiting
Retina Consultants San DiegoPoway, CaliforniaUnited StatesRecruiting
Bay Area Retina AssociatesWalnut Creek, CaliforniaUnited StatesRecruiting
Retina Group of FloridaFort Lauderdale, FloridaUnited StatesRecruiting
VitreoRetinal Associates, PAGainesville, FloridaUnited StatesRecruiting
Retina Specialty InstitutePensacola, FloridaUnited StatesRecruiting
Retina Vitreous Associates of FloridaSt. Petersburg, FloridaUnited StatesRecruiting
Georgia RetinaMarietta, GeorgiaUnited StatesRecruiting
Marietta Eye ClinicMarietta, GeorgiaUnited StatesRecruiting
University RetinaLemont, IllinoisUnited StatesRecruiting
Midwest Eye InstituteCarmel, IndianaUnited StatesRecruiting
Maine Eye CenterPortland, MaineUnited StatesRecruiting
Retina SpecialistsBaltimore, MarylandUnited StatesRecruiting
The Retina Group of WashingtonChevy Chase, MarylandUnited StatesRecruiting
Cumberland Valley Retina ConsultantsHagerstown, MarylandUnited StatesRecruiting
Ophthalmic Consultants of BostonBoston, MassachusettsUnited StatesRecruiting
Foundation for Vision ResearchGrand Rapids, MichiganUnited StatesRecruiting
Retina Consultants of MinnesotaSaint Louis Park, MinnesotaUnited StatesRecruiting
The Retina InstituteSt Louis, MissouriUnited StatesRecruiting
Sierra Eye AssociatesReno, NevadaUnited StatesRecruiting
Retina-Vitreous Surgeons of Central New YorkLiverpool, New YorkUnited StatesRecruiting
Asheville Eye Associates - Western Carolina Retinal AssociatesAsheville, North CarolinaUnited StatesRecruiting
Duke Eye CenterDurham, North CarolinaUnited StatesRecruiting
Graystone EyeHickory, North CarolinaUnited StatesRecruiting
NC Retina AssociatesWake Forest, North CarolinaUnited StatesRecruiting
Cincinnati Eye InstituteCincinnati, OhioUnited StatesRecruiting
Cleveland Clinic Main CampusCleveland, OhioUnited StatesRecruiting
Verum Research LLCEugene, OregonUnited StatesRecruiting
Cascade Medical Research Institute, LLCSpringfield, OregonUnited StatesRecruiting
Erie Retina ResearchErie, PennsylvaniaUnited StatesRecruiting
Charleston Neuroscience Institute, LLCBeaufort, South CarolinaUnited StatesRecruiting
Austin Clinical ResearchAustin, TexasUnited StatesRecruiting
Texas Retina AssociatesDallas, TexasUnited StatesRecruiting
UT Southwestern Medical CenterDallas, TexasUnited StatesRecruiting
Retina Associates Of South Texas P ASan Antonio, TexasUnited StatesRecruiting
Retina Consultants of TexasThe Woodlands, TexasUnited StatesRecruiting
Strategic Clinical Research GroupWillow Park, TexasUnited StatesRecruiting
University of UtahSalt Lake City, UtahUnited StatesRecruiting
Piedmont Eye CenterLynchburg, VirginiaUnited StatesRecruiting
Wagner Kapoor Research instituteNorfolk, VirginiaUnited StatesRecruiting
Spokane Eye Clinical ResearchSpokane, WashingtonUnited StatesRecruiting
Centre for Eye Research AustraliaEast MelbourneAustraliaRecruiting
Strathfield Retina ClinicStrathfieldAustraliaRecruiting
Sydney Retina Clinic and Day SurgerySydneyAustraliaRecruiting
Sydney West RetinaWestmeadAustraliaRecruiting
Ziekenhuis Oost-LimburgGenkBelgiumActive not recruiting
UZ GentGhentBelgiumActive not recruiting
UZ Leuven GasthuisbergLeuvenBelgiumActive not recruiting
Alberta Retina ConsultantsEdmonton, AlbertaCanadaCompleted
Beijing Tongren Hospital CMUBeijingChinaRecruiting
West China Hospital Si Chuan UniversityChengduChinaRecruiting
Shanghai General HospitalShanghaiChinaRecruiting
Fakultni nemocnice Kralovske VinohradyPragueCzechiaRecruiting
AXON Clinical s.r.o.PragueCzechiaRecruiting
University Hospital Of Copenhagen, Glostrup HospitalGlostrup MunicipalityDenmarkActive not recruiting
Universitaets-Augenklinik BonnBonnGermanyRecruiting
Klinikum Gottingen der Georg August UniversitatGöttingenGermanyRecruiting
Medizinische Hochschule HannoverHanoverGermanyRecruiting
Universitaetsklinikum LeipzigLeipzigGermanyRecruiting
Klinikum LudwigshafenLudwigshafen am RheinGermanyRecruiting
Augenzentrum am St Franziskus Hospital MunsterMünsterGermanyRecruiting
Universitaetsklinikum TuebingenTübingenGermanyRecruiting
Eszak Pesti Centrumkorhaz HonvedkorhazBudapestHungaryRecruiting
Ganglion Orvosi KözpontPécsHungaryRecruiting
Zala Varmegyei Szent Rafael KorhazZalaegerszegHungaryRecruiting
Azienda Ospedaliero Universitaria di FerraraFerraraItalyRecruiting
ASST Fatebenefratelli SaccoMilanItalyRecruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoMilanItalyRecruiting
IRCCS Ospedale San RaffaeleMilanItalyRecruiting
Azienda Ospedaliero Universitaria Luigi VanvitelliNaplesItalyRecruiting
Fondazione Policlinico Universitario A Gemelli IRCCSRomaItalyRecruiting
RadboudumcNijmegenNetherlandsActive not recruiting
Het Oogziekenhuis RotterdamRotterdamNetherlandsActive not recruiting
OftalmikaBydgoszczPolandActive not recruiting
Warszawski Szpital OkulistycznyWarsawPolandActive not recruiting
Uls Coimbra - Hosp. Univ. CoimbraCoimbraPortugalActive not recruiting
Espaco Medico de CoimbraCoimbraPortugalActive not recruiting
Uls Sao JoaoPortoPortugalActive not recruiting
Centro de Oftalmologia BarraquerBarcelonaSpainRecruiting
Centro Medico Teknon S.L.BarcelonaSpainRecruiting
Inst. Cat. de RetinaBarcelonaSpainRecruiting
Clinica Oftalvist ValenciaBurjassotSpainRecruiting
Hosp. La ArruzafaCórdobaSpainRecruiting
Hosp Univ Fund Jimenez DiazMadridSpainRecruiting
Hosp. Univ. 12 de OctubreMadridSpainRecruiting
Clinica Baviera Madrid CastellanaMadridSpainRecruiting
Hosp. Univ. Pta. de Hierro MajadahondaMajadahondaSpainRecruiting
Clinica Univ. de NavarraPamplonaSpainRecruiting
Idc Salud Hosp. Gral. de CatalunyaSant Cugat del VallèsSpainRecruiting
Hosp. Virgen Del RocioSevilleSpainRecruiting
Hosp. Clinico Univ. Lozano BlesaZaragozaSpainRecruiting
S:t Eriks OgonsjukhusStockholmSwedenActive not recruiting
Inselspital Universitatsspital BernBernSwitzerlandRecruiting
Hacettepe University Medical FacultyAnkaraTurkey (Türkiye)Recruiting
Baskent University Ankara HospitalAnkaraTurkey (Türkiye)Recruiting
Dokuz Eylul University Medical FacultyIzmirTurkey (Türkiye)Recruiting

4 more sites not listed.

+Investigators

  • Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC