A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
NCT07798375 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 244
Last updated 2026-09-01
Summary
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of VIS-101 administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD)
Conditions
- Neovascular Age Related Macular Degeneration(nAMD)
Interventions
- BIOLOGICAL
-
VIS-101 6.0mg High concentration
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
- BIOLOGICAL
-
VIS-101 6.0mg High concentration
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
- BIOLOGICAL
-
VIS-101 9.0mg High concentration
VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
- BIOLOGICAL
-
Aflibercept (Eylea)
Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).
Sponsors & Collaborators
-
Visara, Inc.
collaborator INDUSTRY -
Everest Medicines (China) Co.,Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2028-05-31
- Completion
- 2028-10-31
- FDA Drug
- Yes
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