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A Study to Evaluate the Safety and Effect of TO-O-1007 Intravitreal Implant in Subjects With Geographic Atrophy

21. juni 2026 opdateret af: Theratocular Biotek Co.

A Phase I/IIa Trial to Evaluate the Safety, Tolerability and Efficacy After Single Administration of TO-O-1007 (Intravitreal Implant) in Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

This study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TO-O-1007, a biodegradable sustained-release intravitreal implant, for the treatment of Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). A long-acting intravitreal implant providing sustained delivery of API over 6 months may slow the progression of GA lesions while reducing treatment burden associated with frequent intravitreal injections. TO-O-1007 may offer a convenient treatment option with the potential to preserve retinal structure and visual function while maintaining an acceptable safety profile.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

TO-O-1007 is a biodegradable sustained-release intravitreal implant, that is injected into the vitreous cavity of the eye. The implant is designed to gradually degrade over time, providing sustained ocular delivery of API for up to 6 months following a single administration. By continuously inhibiting C3/C5 activation, TO-O-1007 is intended to slow the progression of Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD), with the goal of preserving retinal structure and visual function. In this study, TO-O-1007 will be evaluated for its safety, tolerability, pharmacokinetics, and preliminary efficacy to determine whether it may offer a durable treatment option that reduces treatment burden compared with currently available therapies requiring more frequent intravitreal injections.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

31

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Australien
    • New South Wales (nsw)
      • Hurstville, New South Wales (nsw), Australien, 2220
        • Rekruttering
        • Retina & Eye Consultants
        • Ledende efterforsker:
          • Dr. Derek Chan
        • Kontakt:
      • Sydney, New South Wales (nsw), Australien, 2000
        • Rekruttering
        • Sydney Retina Clinic & Day Surgery
        • Ledende efterforsker:
          • Dr. Andrew Chang
        • Kontakt:
    • Tasmania (tas)
      • Launceston, Tasmania (tas), Australien, 7250
        • Rekruttering
        • Launceston Eye Doctors
        • Kontakt:
        • Ledende efterforsker:
          • Dr. Tze-Yo Toh

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Adults ≥50 years, able to provide informed consent and comply with study procedures.
  2. Non-foveal GA secondary to dry AMD, confirmed by the central reading center.
  3. Total GA area 2.5-17.5 mm² by FAF (≥1.25 mm² for at least one lesion if multifocal).
  4. BCVA ≥24 ETDRS letters (~20/320 Snellen) in the study eye.
  5. IOP ≤21 mmHg in the study eye.

Exclusion Criteria:

  1. Recent participation in intravitreal, GA, or investigational treatment studies.
  2. Pregnant or nursing women.
  3. High myopia (>8 D or axial length >27 mm).
  4. Prior AMD treatment or active/secondary CNV in the study eye.
  5. Current/prior uveitis.
  6. Recent anti-complement therapy.
  7. Use of prohibited medications, investigational products, or immunosuppressive therapies.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TO-O-1007 Low-Dose Cohort (phase I)
3 participants will receive TO-O-1007 (low-dose)
Medicin: TO-O-1007 (low-dose)
TO-O-1007 (low-dose): Participants will receive one TO-O-1007 implant administered by intravitreal injection into the study eye.
Eksperimentel: TO-O-1007 High-Dose Cohort (phase I)
3 participants will receive TO-O-1007 (high-dose)
Medicin: TO-O-1007 (high-dose)
TO-O-1007 (high-dose): Participants will receive two TO-O-1007 implants administered by intravitreal injection into the study eye.
Eksperimentel: TO-O-1007 Low-Dose Arm 1 (phase IIa)
10 participants will receive TO-O-1007 (low-dose)
Medicin: TO-O-1007 (low-dose)
TO-O-1007 (low-dose): Participants will receive one TO-O-1007 implant administered by intravitreal injection into the study eye.
Eksperimentel: TO-O-1007 High-Dose Arm 2 (phase IIa)
10 participants will receive TO-O-1007 (high-dose)
Medicin: TO-O-1007 (high-dose)
TO-O-1007 (high-dose): Participants will receive two TO-O-1007 implants administered by intravitreal injection into the study eye.
Sham-komparator: TO-O-1007 Sham Arm 3 (phase IIa)
5 participants will receive a sham injection.
Procedure: Sham injection
Sham injection: No injection is given. It is a sham injection to keep the participant masked.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Up to 6 months treatment duration
Number and percentage of participants experiencing at least one treatment-emergent adverse event, including serious adverse events and adverse events of special interest.
Up to 6 months treatment duration

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Geographic Atrophy Lesion Growth
Tidsramme: Baseline, Week 12, and Week 24.
Change in the growth rate of square root-transformed total Geographic Atrophy lesion area in the study eye, assessed by fundus autofluorescence (FAF) imaging through Week 24.
Baseline, Week 12, and Week 24.
Visual Function Assessments
Tidsramme: Week 12 and Week 24.
Mean change from baseline in BCVA, LL-BCVA, and low-luminance deficit (LLD), assessed using ETDRS charts under photopic and low-luminance conditions through Week 24.
Week 12 and Week 24.
Exposure endpoint (only for phase I)
Tidsramme: Day 1 pre-dose, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28 post first dosing.
Plasma concentrations of TO-O-1007
Day 1 pre-dose, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28 post first dosing.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Theratocular Biotek Co.

Efterforskere

  • Ledende efterforsker: Dr. Andrew Chang, Sydney Retina Clinic & Day Surgery

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)

2. juni 2026

Primær færdiggørelse (Anslået)

31. august 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

21. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TO-I-1007

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Kliniske forsøg med TO-O-1007 (low-dose)

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