- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07729137
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (EMERALD)
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 2 Study of EO2002 in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction (EMERALD)
Studieoversigt
Status
Betingelser
- Hornhindeødem
- Fuchs' endoteldystrofi
- Fuchs dystrofi
- Tab af endotelcelle i hornhinden
- Pseudofakisk bulløs keratopati
- Endotelcelletab, hornhinde
- Corneal endoteldekompensation
- Fuchs
- Endotellidelse i hornhinden
- Endotel hornhindedystrofi
- Pseudofakisk bulløs keratopati (PBK)
- Corneal Endothelial Dystrophy 1
Intervention / Behandling
Detaljeret beskrivelse
This study is designed to evaluate the safety and efficacy of EO2002, an investigational magnetic human corneal endothelial cell (mHCEC) therapy, in adults with corneal edema secondary to corneal endothelial dysfunction. Participants will be randomized to receive a single intracameral injection of one of two doses of EO2002 (150,000 or 500,000 cells) or placebo.
The study will compare the effects of EO2002 on visual acuity and corneal thickness, while also evaluating safety over a 52-week follow-up period. Approximately 105 participants will be treated at multiple sites in the United States.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Clinical Operations - Emmecell
- Telefonnummer: 650-769-4232
- E-mail: clinicaltrials@emmecell.com
Studiesteder
-
-
California
-
Menlo Park, California, Forenede Stater, 94025
- Clinical Site 1
-
Kontakt:
- Clinical Site 1
- Telefonnummer: 650-769-4232
- E-mail: clinicaltrials@emmecell.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Key Inclusion Criteria:
- Symptomatic central corneal edema that is primarily responsible for loss of vision associated with endothelial dysfunction which may be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.
- Early Treatment Diabetic Retinopathy Study (ETDRS)-best-corrected distance visual acuity between 20 and 65 letters inclusive (≥ 20 and ≤ 65 letters)
Central corneal thickness ≥ 600 μm and ≤ 1,000 μm, OR Medical Monitor review and approval based on either:
- Historical CCT increased by ≥ 50 μm OR
- Findings of edema by corneal tomography or Anterior Segment Optical Coherence Tomography (AS-OCT).
- Participant is considered a surgical candidate for full-thickness corneal transplantation or endothelial (partial thickness) keratoplasty (EK) consistent with standard-of-care indications.
Key Exclusion Criteria:
- Corneal disease in either eye (other than corneal endothelial dysfunction secondary to Fuchs dystrophy or pseudophakic bullous keratopathy) including active or prior herpetic ocular infection, severe dry eye disease (e.g., Sjogren's), or active inflammation.
- Central corneal scarring from trauma, burns, or infection, or band keratopathy
- History of keratoconus or other corneal ectasia (e.g., keratoglobus and pellucid marginal degeneration).
- Visually significant cataract, that may limit the participant's ability to demonstrate treatment-related improvement in BCVA.
- Presence of an anterior chamber, sutured, or scleral-fixated intraocular lens.
- Presence of a multifocal or diffractive intraocular lens.
- Prior vitrectomy.
- Corneal refractive surgery.
- Descemet dettachment
- Minimally invasive glaucoma surgery (MIGS), intraocular pressure (IOP)- lowering implant (e.g., Durysta® or iDose®), or any incisional glaucoma surgery (e.g., trabeculectomy, glaucoma drainage implant).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 150K cells - EO2002
Intracameral injection of 150K magnetic human corneal endothelial cells
|
Intracameral injection - 150K dose
|
|
Eksperimentel: 500K cells - EO2002
Intracameral injection of 500K magnetic human corneal endothelial cells
|
Intracameral injection - 500K dose
|
|
Placebo komparator: Placebo
Intracameral injection of vehicle (no cells)
|
Intracameral injection of vehicle
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
BCVA
Tidsramme: 26 weeks
|
Proportion of study eyes achieving ≥ 15-letter best-corrected visual acuity (BCVA) improvement at 26 weeks post-treatment as compared to baseline.
|
26 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
BCVA
Tidsramme: 26 weeks
|
Mean change in BCVA compared to baseline
|
26 weeks
|
|
CCT
Tidsramme: 26 weeks
|
Mean change in CCT compared to baseline
|
26 weeks
|
|
BCVA
Tidsramme: 26 weeks
|
Proportion of subjects achieving ≥10-letter BCVA improvement from baseline
|
26 weeks
|
|
BCVA
Tidsramme: 26 weeks
|
Proportion of subjects achieving ≥70 letters (ETDRS)
|
26 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Noelia Kunzevitzky, PhD, Emmecell
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Postoperative komplikationer
- Patologiske processer
- Genetiske sygdomme, medfødte
- Øjensygdomme
- Hornhindedystrofier, arvelig
- Hornhindesygdomme
- Øjensygdomme, arvelig
- Øjenmanifestationer
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Fuchs' endoteldystrofi
- Hornhindeødem
- Tab af endotelcelle i hornhinden
- Korneal endoteldystrofi type 2
- Corneal Endothelial Dystrophy 1
Andre undersøgelses-id-numre
- EMME-002
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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