PRL3-zumab Phase I/II Placebo-Controlled Trial for Neovascular Age-Related Macular Degeneration
Summary
NIH registered a Phase I/II single-center, placebo-controlled clinical trial (NCT07547228) to evaluate the safety and efficacy of PRL3-zumab administered intravenously at 3mg/kg or 6mg/kg every two weeks for three doses in patients with neovascular Age-related Macular Degeneration (nAMD) who have failed standard-of-care therapy. The trial enrolls 15 participants across three arms (3mg/kg n=6, 6mg/kg n=6, placebo n=3) randomised 2:2:1, with 20 weeks of post-dose monitoring and primary safety endpoints assessed every four weeks through week 24.
“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).”
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What changed
This document registers a Phase I/II clinical trial on ClinicalTrials.gov, providing public notice of an interventional study evaluating PRL3-zumab for neovascular Age-related Macular Degeneration. The trial is single-center, placebo-controlled, and enrolls 15 participants across three arms with randomised 2:2:1 allocation.
Pharmaceutical sponsors and clinical research organisations conducting ophthalmic drug development should note this trial targets a refractory nAMD population (failed SOC therapy), using an intravenous dosing route not typical for standard AMD treatments. Trial registration on ClinicalTrials.gov satisfies applicable transparency and reporting obligations under clinical trial registration requirements.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Phase I/II Study of PRL3-zumab in Neovascular Age-related Macular Degeneration (nAMD)
Phase 1 NCT07547228 Kind: PHASE1 Apr 23, 2026
Abstract
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. Normal saline (0.9% Sodium Chloride w/v) will be used in placebo treatment. The study will consist of 3 arms.
Arm-1: PRL3-zumab 3mg/kg intravenously in 2 week interval followed by 20 weeks of monitoring (n=6) Arm-2: PRL3-zumab 6mg/kg intravenously in 2 week interval followed by 20 weeks of monitoring (n=6) Arm-3: Placebo (normal saline 0.9% sodium chloride w/v) intravenously in 2 week interval followed by 20 weeks of monitoring (n=3)
Initial 3 arms will be conducted on patients who failed Standard-of-Care (SOC) therapy.
Response assessment will be done at every 4 weeks from last dose of treatment till 24-week.
Randomization:
Randomization will be done in 2:2:1 manner on PRL3-zumab (group 1), 3mg/kg (n=6); PRL3-zumab (group 2), 6mg/kg (n=6); and placebo group (group 3) (n=3). Randomization can be achieved using random number table which will be prepared before the commencement of clinical trial.
The allocation of participants will be done by Investigator and will be concealed from the participants.
Blinding:
Single blinding will be done for this trial in which all participants are unaware of their treatment assignment. No blinding will be done on Investigator.
Primary Endpoints:
- Safety:
• Ad...
Conditions: Neovascular Age Related Macular Degeneration
Interventions: PRL3-ZUMAB, Normal Saline (0.9% Sodium Chloride)
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