Actively Recruiting
Phase I/II Study to Assess Safety and Efficacy of PRL3-zumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Led by Intra-IMMUSG Pte Ltd · Updated on 2026-04-29
15
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
I
Intra-IMMUSG Pte Ltd
Lead Sponsor
N
National University Hospital, Singapore
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of PRL3-zumab in patients with Neovascular Age-related Macular Degeneration (nAMD) who have not responded to standard treatments. This Phase I/II, randomized, single-blind, placebo-controlled trial aims to confirm the recommended dose of PRL3-zumab and assess its impact on vision and retinal thickness. The study is sponsored by Intra-IMMUSG Pte Ltd and involves three groups receiving different doses or placebo. Participants will receive PRL3-zumab intravenously at doses of 3 mg/kg or 6 mg/kg, or a placebo of normal saline. Treatments are given three times every two weeks during the initial 4 weeks. After treatment, all participants undergo 20 weeks of monitoring, with eye exams every 4 weeks to assess vision and retinal changes. If disease activity returns, additional open-label PRL3-zumab treatment may be given based on specific clinical criteria. During the study, safety is closely monitored through adverse event reporting, physical exams, vital signs, and laboratory tests. Vision is measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, and retinal thickness and fluid are assessed with Optical Coherence Tomography (OCT). The total study duration is 24 weeks, including treatment and follow-up, to evaluate both safety and visual outcomes.
CONDITIONS
Brief Title
A Study of PRL3-zumab in Neovascular Age-related Macular Degeneration (nAMD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Neovascular Age-related Macular Degeneration (nAMD).
- Willing to provide written informed consent for the study.
- Patients undergoing intravitreal treatment having failed at least two Standard-of care treatments and be receiving ongoing intravitreal treatment at intervals of 64 8 weeks including Ranibizumab, Aflibercept, or Faricimab.
- Participants receiving intravitreal treatment at screening must complete a wash-out period before enrolment based on five half-lives of the specific intravitreal treatment.
- Presence of subfoveal CNV or juxtafoveal/extrafoveal CNV with a subfoveal component related to CNV activity identified by FFA or OCT.
- Best Corrected Visual Acuity (BCVA) ETDRS letter score of 78 to 24 in the study eye.
- Decrease in BCVA primarily due to nAMD or diabetic retinopathy/diabetic macular edema in the study eye.
- Presence of pigment epithelium detachment (PED), intraretinal fluid (IRF), and/or subretinal fluid (SRF) affecting the central study eye on OCT.
- Adequate liver, renal, and hematological function within normal range or clinically insignificant abnormalities.
You will not qualify if you...
- Scar, fibrosis, atrophy, or retinal pigment epithelial tears involving the central fovea in the study eye.
- Uncontrolled glaucoma with intraocular pressure above 25 mmHg despite treatment.
- History of idiopathic or autoimmune uveitis in the study eye.
- Myopia of at least 8 diopters in the study eye before any refractive or cataract surgery.
- Evidence of extraocular or periocular infection or inflammation in either eye at screening.
- Uncontrolled blood pressure with systolic over 160 mmHg or diastolic over 95 mmHg.
- Use of systemic glucocorticoids over 10mg prednisolone daily or other immunosuppressive treatments for autoimmune or other medical conditions.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive intravenous doses of PRL3-zumab or placebo at 2-week intervals over 4 weeks.
3 visits (in-person) every 2 weeks
Duration - 20 weeks
Participants are monitored every 4 weeks for 20 weeks to assess safety and efficacy after treatment ends.
5 visits (in-person) every 4 weeks
Trial Site Locations
Total: 1 location
1
NUHS Department of Ophthalmology
Singapore, Singapore
Actively Recruiting
Research Team
D
Dr Koon Hwee Ang (David)
D
Dr Min Thura
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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