FindTrial
Sign In

ORACLE: A long-term follow-up study to evaluate the safety and durability of GT005 in participants with geographic atrophy, secondary to age-related macular degeneration treated in a Gyroscope-sponsored antecedent study.

ORACLE: A long-term follow-up study to evaluate the safety and durability of GT005 in participants with geographic atrophy, secondary to age-related macular degeneration treated in a Gyroscope-sponsored antecedent study. - GT-ORACLE

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56154
Enrollment
15
Registered
2022-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

Geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Interventions

None listed

Sponsors

Gyroscope Therapeutics Ltd.
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Able and willing to give written informed consent 2. Received GT005 in an antecedent study, GT005-02 (EXPLORE, NCT04437368 and GT005-03 (HORIZON, NCT04566445) 3. Willing to attend study visits and complete the study procedures.

Exclusion criteria

Exclusion criteria: Not Applicable. If the participant is not able to attend Week 96 visit (End of Study visit for antecedent study) due to personal or medical reasons, the Sponsor should be consulted, and participant asked to attend the Study Centre at their next available opportunity to complete the Visit 1 for the ORACLE study.

Design outcomes

Primary

MeasureTime frame
To evaluate the long-term safety of GT005—

Secondary

MeasureTime frame
To evaluate the long-term durability of GT005 on GA progression. To evaluate the long-term durability of GT005 on functional measures—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)