Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease
NCT05986786 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2025-04-22
Summary
This is a single-arm, open label, multicenter clinical study to evaluate the handling and safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease followed by an optional extension phase of AVT06 pre-filled syringe (PFS)
Conditions
- Chorioretinal Vascular Disease
Interventions
- DEVICE
-
Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule
Patient will receive AVT06 (proposed aflibercept biosimilar) PFS injection
Sponsors & Collaborators
-
Alvotech Swiss AG
lead INDUSTRY
Principal Investigators
-
Hans-Juergen Agostini · University Clinic Freiburg
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-28
- Primary Completion
- 2024-04-19
- Completion
- 2025-03-21
Countries
- Georgia
Study Locations
More Related Trials
-
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe
NCT05161806 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
NCT01024998 ·Status: COMPLETED ·Phase: PHASE1
-
Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)
NCT05769153 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT07215234 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
AAVCAGsCD59 for the Treatment of Wet AMD
NCT03585556 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System
NCT00100087 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration
NCT06495918 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
NCT05986864 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Safety Study of CNTO 2476 in Patients With Age-Related Macular Degeneration
NCT01226628 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
NCT01255462 ·Status: COMPLETED ·Phase: PHASE1
-
Long-term Follow-up Study in Subjects Who Received Voretigene Neparvovec-rzyl (AAV2-hRPE65v2)
NCT03602820 ·Status: ACTIVE_NOT_RECRUITING
-
A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)
NCT06510816 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
ONL1204 Ophthalmic Solution in Patients With Geographic Atrophy Associated With Age-related Macular Degeneration
NCT04744662 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety Study of CNTO 2476 in Participants With Visual Acuity Impairment Associated With Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)
NCT02895815 ·Status: WITHDRAWN ·Phase: PHASE2
-
Ocular Safety and Usability Study for FYB201 PFS
NCT06708624 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
NCT01722045 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration
NCT03777254 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1/2, First-in-Human Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Subretinal Injection of SB-007 in Subjects With Stargardt Disease (STGD1)
NCT06942572 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)
NCT00511706 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)
NCT03539549 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy
NCT06779773 ·Status: RECRUITING
-
Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
NCT05859776 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration
NCT04270669 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
NCT04704921 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)
NCT05155293 ·Status: COMPLETED ·Phase: PHASE3