Conditions: Neovascular Age-Related Macular Degeneration
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 18
Healthy volunteers: no

Brief summary:
Phase 1: The purpose of this study is to evaluate the safety and tolerability of single ascending doses of hI-con1™ for subjects with Age-Related Macular Degeneration.

Phase 2: The purpose of this study is to evaluate the safety of 3 injections of hI-con1™ at 2 different dose levels.

Detailed description:

Arms:
arm 1: Phase 1- This is a dose escalation study (60µl, 150µl, or 300 µl) given at baseline and then the subject is followed up to week 24. arm 2: Phase 1- This is a dose escalation study (60µl, 150µl, or 300 µl) given at baseline and then the subject is followed up to week 24. arm 3: Phase 1- This is a dose escalation study (60µl, 150µl, or 300 µl) given at baseline and then the subject is followed up to week 24.

Interventions: intervention 1: hI-con1™ 60µl intervention 2: hI-con1™ 150µl intervention 3: hI-con1™ 300µl
Intervention descriptions: intervention 1: Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only intervention 2: Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only intervention 3: Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only

Protocol document: