TENECTEPLASE IN CENTRAL RETINAL ARTERY OCCLUSION STUDY (TenCRAOS): A Prospective, randomised-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomisation)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517606-29-00

Enrollment

Registered

2024-10-31

Start date

2020-10-30

Completion date

Unknown

Last updated

2024-11-05

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

Conditions

Central retinal artery occlusion

Brief summary

Primary endpoint: Proportion of patients with ≤ 0.7 logMAR best-corrected visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in best-corrected visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).

Interventions

DRUGencapsulated tablets of inactive substance

DRUGAlbyl-E 75 mg enterotabletter

DRUGTENECTEPLASE

DRUGSodium Chloride Fresenius Kabi Italia 0.9 % Solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary endpoint: Proportion of patients with ≤ 0.7 logMAR best-corrected visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in best-corrected visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).	—

Countries

Belgium, Denmark, Finland, Ireland, Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026