Macular Edema Clinical Trial
Official title:
An Open-label, Single Group, Single-dose Clinical Study to Evaluate the Usability of the Pre-filled Syringe of SB11 in Subjects With Neovascular Age-Related Macular Degeneration or Macular Oedema Secondary to Retinal Vein Occlusion
Verified date | December 2023 |
Source | Samsung Bioepis Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 12, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Neovascular AMD or macular oedema secondary to RVO in the study eye - Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the ophthalmologist (e.g., retina specialist) - Aged 18 years and older at the time of signing the informed consent form (ICF) - Written ICF must be obtained from the subject prior to any study-related procedure (if the subject cannot read ICF, an impartial witness will be present during the entire informed consent discussion) - Willingness and ability to undertake all scheduled visits and assessments Exclusion Criteria: - Best Corrected Visual Acuity (BCVA) of the level of Finger Count or worse [i.e., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart] in one or both eyes at Screening or at Day 1 - History of and/or current intraocular inflammation (any grading from trace and greater is excluded), including non-infectious uveitis, infectious uveitis, or scleritis, or history of sterile inflammatory reaction after the past ITV injections with any agent in either eye - Active or suspected infectious disease, or active disorder that preclude safe use of IP at the discretion of the Investigator, in either eye or adnexa of either eye at Screening or at Day 1 - History of excessive bleeding and recurrent haemorrhages, including any prior excessive intraocular bleeding or haemorrhages after ITV injection or intraocular procedures in either eye - History of massive subconjunctival haemorrhages of concern reported by the subject after an ITV injection in either eye - Uncontrolled intraocular pressure (IOP) greater than (=) 25 mmHg in the study eye at Screening or at Day 1 - Treatment with any ITV injection within the 30 days prior to Day 1 in the study eye - Any invasive ocular surgery including retinal detachment surgery, long-acting ocular therapeutic agent/implant including corticosteroid, or ocular drug release device implant (approved or investigational) in the study eye within 90 days prior to Day 1 or planned intraocular surgery within next 28 days after Day 1 - Ocular laser surgery in study eye at any time within the past 30 days prior to Day 1 - Treatment with any ocular IP in either eye within 90 days prior to Day 1 - Treatment with systemic anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days prior to Day 1 - Receipt of any systemic (non-ocular) IP within 180 days prior to Day 1 - Use of therapies that are known to be toxic to ocular tissue within the 180 days prior to Day 1, including, but not limited to, deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, or ethambutol - Known ocular or non-ocular conditions that per the ophthalmologist (e.g., retina specialist) represent a contraindication to ranibizumab use in the patient or may represent an unwarranted patient risk - Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg while sitting confirmed after repeated measurement) at Screening or Day 1 - Current systemic infectious disease or therapy for active infectious disease - Pregnant or lactating women at Screening or at Day 1 Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply |
Country | Name | City | State |
---|---|---|---|
Poland | SB Investigational Site | Katowice | |
Poland | SB Investigational Site | Kraków | |
Poland | SB Investigational Site | Olsztyn |
Lead Sponsor | Collaborator |
---|---|
Samsung Bioepis Co., Ltd. |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of successful task completions | Total of 12 tasks were evaluated, and the percentage of HCP's successful task completions were measured. | Day 1 | |
Secondary | Percentage of successful completion on critical tasks | Total of 6 tasks were considered as critical task, and the percentage of HCP's successful completion on critical tasks were evaluated. | Day 1 | |
Secondary | Percentage of successful completion on essential tasks | Total of 6 tasks were considered as essential task, and the percentage of HCP's successful completion on essential tasks were evaluated. | Day 1 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04292912 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema
|
Phase 1 | |
Recruiting |
NCT05976139 -
Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies
|
N/A | |
Completed |
NCT03660345 -
PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME
|
Phase 3 | |
Completed |
NCT03660371 -
ILM Peeling in PDR Patients Undergoing PPV for VH
|
N/A | |
Completed |
NCT01660802 -
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
|
Phase 3 | |
Completed |
NCT01908816 -
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
|
Phase 3 | |
Completed |
NCT04592419 -
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
|
Phase 3 | |
Completed |
NCT02867735 -
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
|
Phase 1 | |
Completed |
NCT02623673 -
Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema
|
N/A | |
Terminated |
NCT01946399 -
Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF
|
N/A | |
Completed |
NCT01428388 -
Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion
|
N/A | |
Completed |
NCT01231633 -
Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
|
N/A | |
Recruiting |
NCT01023113 -
To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation
|
N/A | |
Terminated |
NCT00918554 -
Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis
|
Phase 4 | |
Terminated |
NCT00969293 -
Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion
|
Phase 1 | |
Completed |
NCT00970957 -
Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion
|
Phase 3 | |
Completed |
NCT00476593 -
Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications
|
N/A | |
Completed |
NCT00411970 -
20- Versus 23- Gauge System for Pars Plana Vitrectomy
|
Phase 4 | |
Completed |
NCT00668239 -
Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser
|
N/A | |
Terminated |
NCT01939691 -
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
|
Phase 4 |