Ocular Safety and Usability Study for FYB201 PFS
NCT06708624 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2024-11-27
Summary
The objective of the study is to assess the ocular safety of the FYB201 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.
Conditions
- Age-Related Macular Degeneration
- Branch Retinal Vein Occlusion with Macular Edema
- Central Retinal Vein Occlusion with Macular Edema
Interventions
- DRUG
-
FYB201 0.5 mg (0.05 mL of 10 mg/mL)
IVT administration of FYB201 in a PFS
Sponsors & Collaborators
-
Formycon AG
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-11
- Primary Completion
- 2024-08-08
- Completion
- 2024-08-08
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Safety and Tolerability of OCU-10-C-110 for Injection in Subjects With Neovascular Age-related Macular Degeneration
NCT05904691 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease
NCT05986786 ·Status: COMPLETED ·Phase: PHASE3
-
Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
NCT00695318 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses
NCT07330674 ·Status: RECRUITING ·Phase: PHASE1
-
Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).
NCT01624636 ·Status: TERMINATED ·Phase: PHASE2
-
ARC1905 (Anti-C5 Aptamer) Given With Lucentis 0.5 mg In People With Neovascular Age-Related Macular Degeneration
NCT00709527 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration
NCT03777254 ·Status: COMPLETED ·Phase: PHASE1
-
FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD
NCT03846193 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Phase 1/2 Study of the Safety and Efficacy of BRX011 Oral Administration Once Daily in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT07029945 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration
NCT00090532 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Phase II/III Study of Anti-VEGF in Neovascular AMD
NCT00021736 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe
NCT05569148 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD
NCT02214628 ·Status: TERMINATED ·Phase: PHASE2
-
Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)
NCT06011798 ·Status: COMPLETED ·Phase: PHASE2
-
Fluocinolone Implant to Treat Macular Degeneration
NCT00008515 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of an Encapsulated Cell Technology (ECT) Implant for Patients With Atrophic Macular Degeneration
NCT00447954 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 1, Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration
NCT00569140 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)
NCT01535950 ·Status: COMPLETED ·Phase: PHASE2
-
OcuDyne System in the Treatment of AMD
NCT05091476 ·Status: COMPLETED ·Phase: NA
-
A Study of Encapsulated Cell Technology (ECT) Implant for Participants With Early Stage Retinitis Pigmentosa
NCT00447980 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion
NCT00913744 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I Dose Escalation Safety Study of RetinoStat in Advanced Age-Related Macular Degeneration (AMD)
NCT01301443 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of ARC1905 (Anti-C5 Aptamer) in Subjects With Dry Age-related Macular Degeneration
NCT00950638 ·Status: COMPLETED ·Phase: PHASE1
-
A Multi-Center, Open Label, Extension Study Assessing the Efficacy and Safety of Additional Intravitreal Injections of RBM-007 in Subjects With Wet Age-related Macular Degeneration
NCT04640272 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe
NCT05161806 ·Status: COMPLETED ·Phase: PHASE3