A Study of PRL3-zumab in Neovascular Age-related Macular Degeneration (nAMD)

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 will be administered in 2 week interval followed by 20 weeks of monitoring (n=6) Arm-2: PRL3-zumab 6mg/kg intravenously will be administered in 2 week interval followed by 20 weeks of monitoring (n=6) Arm-3: Placebo (normal saline 0.9% sodium chloride w/v) intravenously will be administered 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 (Arm 1), 3mg/kg (n=6); PRL3-zumab (Arm 2), 6mg/kg (n=6); and placebo group (Arm 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 I…

This description comes directly from the study's public registry record.

Dr Koon Hwee Ang (David)  ·  +65 65869661  ·  ang.koonhwee@intra-immusg.com

Dr Min Thura  ·  min.thura@intra-immusg.com

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