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New treatment option for Neovascular Age Related Macular Degeneration
Official title A Study of PRL3-zumab in Neovascular Age-related Macular Degeneration (nAMD)
ClinicalTrials.gov ID: NCT07547228
What this study is testing
What is PRL3-ZUMAB?
PRL3-ZUMAB is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for neovascular age related macular degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study Design This is a Single-center, Phase I/II placebo-controlled study to assess the safety and efficacy of PRL3-zumab in patients with Neovascular Age-related Macular Degeneration (nAMD). PRL3-zumab will be administered intravenously in 2-week interval for 3 doses.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Participants receiving intravitreal treatment at screening must complete a wash-out period before enrolment. This wash-out period should be...
- Ranibizumab (half-life: 9 days) requires a wash-out period of 45 days (7 weeks)
You likely can't join if
- Scar, fibrosis, atrophy, or retinal pigment epithelial tears involving the central fovea in the study eye.
- Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with antiglaucoma medication) in the study eye.
- History of idiopathic or autoimmune uveitis in the study eye.
- Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
- Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either...
- Uncontrolled blood pressure (defined as systolic \>160 mmHg or diastolic \>95 mmHg).
See the full eligibility criteria
- 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 ≤ 8 weeks including Ranibizumab, Aflibercept, or...
- Participants receiving intravitreal treatment at screening must complete a wash-out period before enrolment. This wash-out period should be calculated based on five half-lives of the specific intravitreal treatment the...
- Ranibizumab (half-life: 9 days) requires a wash-out period of 45 days (7 weeks)
- Aflibercept (half-life: 11 days) requires a wash-out period of 55 days (8 weeks)
- Faricimab (half-life: 7.5 days) requires a wash-out period of 37.5 days (5 weeks)
- Bevacizumab (half-life: 6 days) requires a wash-out period of 30 days (4weeks)
- Subfoveal CNV or juxtafoveal/extrafoveal CNV with a subfoveal component related to the CNV activity identified by FFA or OCT (where CNV activity is defined as showing evidence of subretinal fluid, subretinal...
- BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
- Decrease in BCVA determined to be primarily the result of nAMD or DR/DME in the study eye.
- Presence of pigment epithelium detachment (PED), intraretinal fluid (IRF) and/or subretinal fluid (SRF) affecting the central subfield of the study eye on OCT.
- Adequate organ (liver and renal) and hematological functions as evidenced by the laboratory results obtained within 7 days of treatment which are within the normal range for the study population, or with abnormalities...
- Scar, fibrosis, atrophy, or retinal pigment epithelial tears involving the central fovea in the study eye.
- Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with antiglaucoma medication) in the study eye.
- History of idiopathic or autoimmune uveitis in the study eye.
- Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
- Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.
- Uncontrolled blood pressure (defined as systolic \>160 mmHg or diastolic \>95 mmHg).
- Patient is receiving systemic glucocorticoids (only if higher than 10mg or equivalent of prednisolone daily) or other immunosuppressive treatment for autoimmune disease or any other medical condition.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.