HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
Brief Summary:
The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).
Detailed Description:
This is a Phase 2, open-label, outcomes-assessor masked, multicentre, randomised, controlled study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with GA secondary to AMD.
The trial includes a screening period of up to 8 weeks and a 48-week study period.
Subjects will be randomised to two groups; GT005 or the untreated control group.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase II, open-label, outcomes-assessor masked, multicentre, randomised, controlled study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with GA secondary to AMD.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcome Assessor). The overall objectives of the study are to evaluate the safety and efficacy (anatomical and functional visual outcomes) of two doses of GT005 in genetically defined subjects with GA due to AMD.
Primary Purpose: Treatment
Official Title: HORIZON: A Phase II, Open-label, Outcomes-assessor Masked, Multicentre, Randomised, Controlled Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
Actual Study Start Date: November 11, 2020
Estimated Primary Completion Date: February 28, 2022
Estimated Study Completion Date: February 28, 2022
Arm:
- Experimental: GT005 Dose 1
- Experimental: GT005 Dose 2
- No Intervention: Untreated control
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 180 |
| Actual Study start date | 11 November 2020 |
| Estimated Study Completion Date | 28 February 2022 |