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Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)

A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared with EU-Eylea in Subjects with Neovascular (wet) Age-related Macular Degeneration (ALVOEYE)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031220316
Enrollment
62
Registered
2022-09-02
Start date
2022-09-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neovascular (wet) AMD

Interventions

In the study eye, subjects will receive 2 mg (0.05 mL) intravitreal injection of AVT06 or Eylea every 4 weeks for 3 consecutive monthly visits (Day 1, Week 4, and Week 8) followed by intravitreal inje

Sponsors

Koelbl Stephanie
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Subject must be >= 50 years of age, at the time of signing the informed consent. - Subjects must be diagnosed with neovascular (wet) AMD in the study eye. - Subjects must have active, treatment naive, subfoveal CNV lesions secondary to neovascular (wet) AMD. - Willingness and ability to undertake all scheduled visits and assessments.

Exclusion criteria

Exclusion criteria: - Any prior systemic treatment with anti-VEGF therapy - Any condition that, in the Investigator's opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data - Prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever is longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrollment in any other clinical study involving an investigational study treatment - Subjects not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.

Design outcomes

Primary

MeasureTime frame
Change from baseline to Week 8 in BCVA as measured by ETDRS letter score.

Countries

Argentina, Brazil, Bulgaria, Czech Republic, Georgia, Hungary, India, Japan, Latvia, Poland, Russia, Slovakia, Ukraine

Contacts

Public ContactjRCT Inquiry Contact IQVIA Services Japan G.K.

IQVIA Services Japan G.K.

JP_AVT06-GL-C01_CL@iqvia.com+81-3-6859-9500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026