Actively Recruiting
Identification of Molecular Signals in Vitreous Humor Associated With Suboptimal Response to Vascular Endothelial Growth Factor (VEGF) Inhibition in Neovascular Age-related Macular Degeneration (nAMD) Within a Clinical Trial Setting
Led by Singapore National Eye Centre · Updated on 2025-11-25
117
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neovascular age-related macular degeneration (nAMD), also called wet AMD, can cause serious vision loss. While anti-VEGF (anti Vascular Endothelial Growth Factor) treatments such as ranibizumab help many patients, about 20 40% have a suboptimal response. In this study, the investigators want to identify other factors (beyond VEGF) that might be driving the disease in these non-responding patients. By looking at samples from inside the eye (vitreous humor) and comparing "good responders" to "suboptimal responders", the investigators hope to find potential new treatment approaches or biomarkers for nAMD.
CONDITIONS
Official Title
Identification of Molecular Signals in Vitreous Humor Associated With Suboptimal Response to Vascular Endothelial Growth Factor (VEGF) Inhibition in Neovascular Age-related Macular Degeneration (nAMD) Within a Clinical Trial Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 60 50 years old at the time of informed consent
- Willing and able to provide informed consent
- Willingness and ability to comply with all scheduled visits and study procedures
- Female subjects must be of non-childbearing potential or show a negative pregnancy test at screening and agree to use contraception during the study and for one month after last dose
- Confirmed diagnosis of symptomatic nAMD by optical coherence tomography, fluorescein fundus angiography, and indocyanine green angiography
- nAMD with subfoveal or juxtafoveal/extrafoveal choroidal neovascularization or polypoidal choroidal vasculopathy with subfoveal component related to exudative activity
- Treatment naive with no previous intravitreal anti-VEGF, thermal laser in macular region, or verteporfin photodynamic therapy
- Best corrected visual acuity of 24-78 letters on ETDRS chart (equivalent to 20/32-20/320 vision)
You will not qualify if you...
- Choroidal neovascularization or retinal exudation caused by conditions other than typical AMD, such as vitelliform dystrophy, ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
- Active intraocular inflammation or infection in either eye at baseline
- Other intraocular conditions in the study eye that may require treatment or limit vision improvement, including recent cataract surgery within 6 months or cataract surgery during study
- Retinal pigment epithelium rip or tear in study eye at baseline
- Current or recent vitreous hemorrhage in study eye within 4 weeks prior to baseline
- History of retinal detachment, advanced macular hole, or retinal breaks without adequate repair
- History of previous pars plana vitrectomy, photodynamic therapy, intraocular or refractive surgery within 6 months, penetrating keratoplasty, pan retinal photocoagulation, or submacular surgery in study eye
- Uncontrolled glaucoma or ocular hypertension with intraocular pressure over 25 mmHg
- Use of intra- or periocular corticosteroids in study eye within 6 months prior to baseline or systemic corticosteroids for 30+ days within 90 days prior, except for stable low doses
- Previous therapeutic radiation near study eye
- Medical conditions that would prevent study completion or safe treatment
- Hypersensitivity to study drugs or fluorescein/indocyanine green dyes
- Participation in another investigational drug, biologic, or device study within 30 days or 5 half-lives before baseline
- Systemic anti-VEGF therapy within 90 days prior to baseline
- Stroke or heart attack within 90 days prior to baseline
- Uncontrolled high blood pressure with systolic 60 180 mmHg or diastolic 60 100 mmHg at screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Singapore National Eye Centre/Singapore Eye Research Institute
Singapore, Singapore
Actively Recruiting
Research Team
G
Gemmy Cheung
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
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