Vitrectomy, subretinal Tissue plasminogen activator and Intravitreal Gas for submacular haemorrhage secondary to Exudative age-Related macular degeneration (TIGER): a phase 3, pan-European, two-group, active-control, observer-masked, superiority, randomised controlled surgical trial.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504751-28-00

Acronym

TIGER

Enrollment

Registered

2023-11-20

Start date

2024-09-24

Completion date

Unknown

Last updated

2025-12-16

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

Conditions

Exudative age-related macular degeneration

Brief summary

Gain of at least 10 ETDRS letters in BCVA in the study eye at the month 12 visit.

Detailed description

Gain of at least 10 ETDRS letters (month 6), Mean ETDRS BCVA., Radner reading vision., National Eye Institute 25 item Visual Function Questionnaire composite score., Scotoma size (Humphrey Field Analyser 10-2), Presence/absence of subfoveal fibrosis and/or atrophy and area of fibrosis/atrophy using multimodal reading centre image analysis (month 12).

Interventions

DRUGEylea 40 mg/mL solution for injection in a vial

DRUGActilyse 10 mg powder and solvent for solution for injection and infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Gain of at least 10 ETDRS letters in BCVA in the study eye at the month 12 visit.	—

Secondary

Measure	Time frame
Gain of at least 10 ETDRS letters (month 6), Mean ETDRS BCVA., Radner reading vision., National Eye Institute 25 item Visual Function Questionnaire composite score., Scotoma size (Humphrey Field Analyser 10-2), Presence/absence of subfoveal fibrosis and/or atrophy and area of fibrosis/atrophy using multimodal reading centre image analysis (month 12).	—

Countries

Germany, Ireland, Netherlands, Poland

Outcome results

None listed

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