Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects
22. juni 2021 opdateret af: Santen Inc.
A Multi-Center, Randomized, Double Masked and Active Controlled Phase II Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Wet Age-related Macular Degeneration - AVANTE Study
To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
76
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Makati City, Filippinerne
- Asian Eye Institute
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Makati City, Filippinerne
- Peregrine Eye and Laser Institute
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Pasig City, Filippinerne
- The Medical City
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Quezon City, Filippinerne
- St. Luke's Medical center Quezon City
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Arizona
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Gilbert, Arizona, Forenede Stater, 85296
- Retina Research Institute
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California
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Beverly Hills, California, Forenede Stater, 90211
- Retina-Vitreous Associates
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Mountain View, California, Forenede Stater, 94040
- Northern California Retina Vitreous Associates
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Walnut Creek, California, Forenede Stater, 94598
- Bay Area Retina Associates
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Colorado
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Golden, Colorado, Forenede Stater, 80401
- Colorado Retina Associates
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Florida
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Fort Myers, Florida, Forenede Stater, 33912
- National Ophthalmic Research Institute
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
- Black Hills Regional Eye Institute
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Texas
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Austin, Texas, Forenede Stater, 78705
- Retina Reseach Center
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Houston, Texas, Forenede Stater, 77030
- Retina Consultants of Houston
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McAllen, Texas, Forenede Stater, 78503
- Valley Retina Insititute
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Provide signed written informed consent
- Diagnosis of active choroidal neovascularization secondary to wet AMD
- BCVA of 65 to 25 ETDRS letters (20/50 to 20/320) in the study eye
- BCVA of 25 ETDRS letters (20/320) or better in the fellow eye
Exclusion Criteria:
[Ocular]
- Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1 and throughout the study
- Uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye
- Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study
- Need for ocular surgery in the study eye during the course of the study
- Presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform examinations
[Non-ocular]
- Allergy or hypersensitivity to study drug product, fluorescein dye or other study related procedures and medications
- Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study
- Participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study
- Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study
- Unable to comply with study procedures or follow-up visits
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 2.0 mg DE-122
2.0 mg DE-122 and Lucentis ® 0.5 mg
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Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.
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Eksperimentel: 4.0 mg DE-122
4.0 mg DE-122 and Lucentis ® 0.5 mg
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Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.
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Sham-komparator: Sham
Sham and Lucentis ® 0.5 mg
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Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24
Tidsramme: Week 24
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BCVA is the primary efficacy variable for this study, and mean change from baseline in BCVA at Week 24 is the primary efficacy endpoint. An increase in the number of letters read correctly means that vision has improved.The lower the number of letters read correctly on the eye chart, the worse the vision. |
Week 24
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. juli 2017
Primær færdiggørelse (Faktiske)
31. december 2019
Studieafslutning (Faktiske)
31. januar 2020
Datoer for studieregistrering
Først indsendt
6. juli 2017
Først indsendt, der opfyldte QC-kriterier
6. juli 2017
Først opslået (Faktiske)
7. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juni 2021
Sidst verificeret
1. juni 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 36-002
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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