Phase 2a Study to Evaluate the Efficacy and Safety of SCAI-005 Ophthalmic Solution in Subjects Wi… (NCT07607561) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase 2a Study to Evaluate the Efficacy and Safety of SCAI-005 Ophthalmic Solution in Subjects With Neovascular Age-related Macular Degeneration
50 participantsStarted 2026-11-01
Plain-language summary
Trial to Evaluate the Safety and Efficacy of SCAI-005 Ophthalmic solution in Patients with Neovascular Age-related Macular Degeneration.
The purpose of this study is to investigate the efficacy, safety and tolerability of SCAI-005 Ophthalmic solution by dose in patients with neovascular Age-related Macular Degeneration (nAMD).
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults aged 50 years or older
. Subjects who were diagnosed with nAMD in the study eye within 3 years prior to the Screening Visit, who demonstrated a treatment response to at least 3 repeated intravitreal injections of anti-VEGF IVT for nAMD, and whose last anti-VEGF IVT administration was more than 12 weeks prior to the planned date of the first administration of the investigational product.
. Active MNV secondary to nAMD with a subfoveal component related to the MNV activity in the study eye as assessed by FA (evidence of leakage) or SD-OCT (presence of fluid) at screening
. CST ≤ 450 μm at screening
. BCVA ETDRS letter score of 80 letters to 25 letters in the study eye as measured by the ETDRS visual acuity chart at screening
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)
. Presence of scarring, fibrosis, or atrophy involving the fovea in the study eye at Screening
. Subjects who have a hemorrhage in the subfoveal region of the study eye and in whom the subretinal hemorrhage area is ≥ 1 optic disk area
. History of glaucoma surgery, vitrectomy, submacular surgery, or macular laser treatment (e.g., photodynamic therapy \[PDT\], laser photocoagulation, etc.) in the study eye
. Subjects with vitreous hemorrhage in the study eye
. History of ocular treatment (except for anti-VEGF IVT therapy), systemic treatment, or surgical intervention for the treatment of neovascular age-related macular degeneration (nAMD) in the study eye
. Administration of intraocular, periocular, or intravitreal (IVT) steroid injection in the study eye within 24 weeks prior to Screening
. Presence of diabetic retinopathy, diabetic macular edema, or other vascular diseases affecting the retina, other than neovascular age-related macular degeneration (nAMD), in either eye