BridgeMD
An open-label, single group, single-dose clinical study to evaluate the usability of the pre-filled syringe (PFS) of SB11 in trial participants with Neovascular Age-Related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Myopic Choroidal Neovascularization (mCNV)
EU CTIS ID: 2025-520599-24-00
What this study is testing
The primary objective of this study is to assess the ability of Healthcare Professionals (HCPs) to follow the instructions for use (IFU) to prepare and administer SB11 PFS intravitreal (IVT) injection to trial participants.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Neovascular AMD, macular oedema secondary to RVO, or mCNV in the study eye
- Study eye deemed to be indicated for ranibizumab IVT 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 trial participant prior to any study-related procedure (if the trial participant 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
- Non-childbearing potential female (e.g., having congenital or acquired condition that prevents childbearing, having history of hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion) or postmenopausal [defined as amenorrhoea of at least 12 months without an alternative medical cause prior to the time of ICF signing] OR Childbearing potential female trial participants or male trial participants with their (respectively male or female) partners who agree to use at least 2 forms of appropriate contraception method (e.g., established use of oral, injected, intravaginal, transdermal or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner or physical barrier [Note: Female condom and male condom should not be used together]) or 1 highly effective contraception method (e.g., sexual abstinence) from Screening until 3 months after the IVT injection of investigational product (IP). Note: Vasectomy will be allowed for male trial participants and female trial participants of childbearing potential with a sole vasectomised male partner. Vasectomised trial participants or partners should be medically confirmed for sterilisation. True abstinence alone will be allowed if this is in line with the preferred and usual lifestyle of the trial participant, or for trial participants who do not have a partner. Periodic abstinence (e.g., calendar, ovulation, symptothermal postovulation methods) and withdrawal are not acceptable methods of contraception.
You likely can't join if
- Best Corrected Visual Acuity (BCVA) of the level of Finger Count or worse [e.g., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart] in one or both eyes at Screening or at Day 1
- Treatment with any ocular IP in either eye within 90 days prior to Day 1
- Treatment with systemic (non-ocular) anti-Vascular Endothelial Growth Factor (anti-VEGF) 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
See the full eligibility criteria
Who can join
- Neovascular AMD, macular oedema secondary to RVO, or mCNV in the study eye
- Study eye deemed to be indicated for ranibizumab IVT 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 trial participant prior to any study-related procedure (if the trial participant 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
- Non-childbearing potential female (e.g., having congenital or acquired condition that prevents childbearing, having history of hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion) or postmenopausal [defined as amenorrhoea of at least 12 months without an alternative medical cause prior to the time of ICF signing] OR Childbearing potential female trial participants or male trial participants with their (respectively male or female) partners who agree to use at least 2 forms of appropriate contraception method (e.g., established use of oral, injected, intravaginal, transdermal or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner or physical barrier [Note: Female condom and male condom should not be used together]) or 1 highly effective contraception method (e.g., sexual abstinence) from Screening until 3 months after the IVT injection of investigational product (IP). Note: Vasectomy will be allowed for male trial participants and female trial participants of childbearing potential with a sole vasectomised male partner. Vasectomised trial participants or partners should be medically confirmed for sterilisation. True abstinence alone will be allowed if this is in line with the preferred and usual lifestyle of the trial participant, or for trial participants who do not have a partner. Periodic abstinence (e.g., calendar, ovulation, symptothermal postovulation methods) and withdrawal are not acceptable methods of contraception.
What rules you out
- Best Corrected Visual Acuity (BCVA) of the level of Finger Count or worse [e.g., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart] in one or both eyes at Screening or at Day 1
- Treatment with any ocular IP in either eye within 90 days prior to Day 1
- Treatment with systemic (non-ocular) anti-Vascular Endothelial Growth Factor (anti-VEGF) 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
- Known history of intolerance, reaction to prior biological therapies
- Pregnant or lactating women 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 IVT 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 IVT injection or intraocular procedures in either eye
- History of massive subconjunctival haemorrhages of concern reported by the trial participant after an IVT 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 IVT 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.