FocuS: First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 10
Summary
- Conditions
- Dry Age Related Macular Degeneration
- Eye Diseases
- Geographic Atrophy
- Macular Atrophy
- Macular Degeneration
- Retinal Degeneration
- Retinal Disease
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: A dose escalation study of the safety and efficacy of a single subretinal injection of GT005 in subjects with Macular Atrophy due to AMDMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 55 years and 125 years
- Gender
- Both males and females
Description
This study will evaluate the safety, the dose response and efficacy (anatomical and functional visual outcomes) of three doses of GT005 administered as a single subretinal injection in genetically defined subjects with Macular Atrophy due to Age-related Macular Degeneration (AMD). Following consent,...
This study will evaluate the safety, the dose response and efficacy (anatomical and functional visual outcomes) of three doses of GT005 administered as a single subretinal injection in genetically defined subjects with Macular Atrophy due to Age-related Macular Degeneration (AMD). Following consent, subjects will undergo a number of ophthalmic and clinical assessments to determine eligibility for inclusion in the study. Once eligibility is confirmed, subjects will be enrolled, receive treatment, and will be followed for 48 weeks.
Tracking Information
- NCT #
- NCT03846193
- Collaborators
- Not Provided
- Investigators
- Study Director: Chief Medical Officer Gyroscope Therapeutics Gyroscope Therapeutics Limited
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