Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54-VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)
NCT06550011 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-02-12
Summary
This will be a clinical study to assess initial safety and tolerability of IVT ABI-110 in patients diagnosed with wet macular degeneration (wAMD), including symptomatic macular PCV.
Conditions
- Neovascular (Wet) AMD
Interventions
- DRUG
-
ABI-110 Low Dose
Low dose. lower than the safety factor of 10 as recommended by the FDA
- DRUG
-
ABI-110 Medium Dose
Medium dose
- DRUG
-
ABI-110 High Dose
High Dose
Sponsors & Collaborators
-
Avirmax Biopharma Inc
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 50 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-07
- Primary Completion
- 2027-01-13
- Completion
- 2031-01-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD
NCT00383370 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation the Pharmacokinetics, Safety, Tolerability of TK001 in Patients With Neovascular Age-related Macular Degeneration
NCT02613559 ·Status: UNKNOWN ·Phase: PHASE1
-
Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT07160179 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Patients With Neovascular AMD
NCT02859766 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
NCT04964089 ·Status: COMPLETED ·Phase: PHASE3
-
Treatment of Advanced Dry Age Related Macular Degeneration With AAVCAGsCD59
NCT03144999 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD
NCT02461771 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD)
NCT03861234 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
NCT00637377 ·Status: COMPLETED ·Phase: PHASE3
-
Phase II/III Study of Anti-VEGF in Neovascular AMD
NCT00021736 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
NCT02540954 ·Status: COMPLETED ·Phase: PHASE3
-
A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
NCT05919693 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
NCT04049266 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO
NCT03790852 ·Status: TERMINATED ·Phase: PHASE1
-
AAVCAGsCD59 for the Treatment of Wet AMD
NCT03585556 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
NCT01024998 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses
NCT07330674 ·Status: RECRUITING ·Phase: PHASE1
-
Intravitreal Aflibercept for Submacular Hemorrhage
NCT03169660 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
NCT06556368 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)
NCT00509795 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration
NCT03777254 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Intravitreally Administered AIV007 in Subjects With Neovascular Age-Related Macular Degeneration
NCT04422899 ·Status: COMPLETED ·Phase: PHASE1
-
Treat-and-extend Using Aflibercept for Type 3 Neovascularization
NCT04655482 ·Status: UNKNOWN ·Phase: PHASE4
-
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
NCT04126317 ·Status: COMPLETED ·Phase: PHASE2
-
Managing Neovascular (Known as "Wet") Age-related Macular Degeneration Over 2 Years Using Different Treatment Schedules of 2 mg Intravitreal Aflibercept Injected in the Eye
NCT02581891 ·Status: COMPLETED ·Phase: PHASE4