💬In plain words
What the trial is, and whether it could suit you
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 ev
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📋 Eligibility rules (as published)
Inclusion Criteria:
1. Patients with Neovascular Age-related Macular Degeneration (nAMD).
2. Willing to provide written informed consent for the study.
3. 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 Faricimab.
4. 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 participant is receiving.
Below is the washing out period for some standard of care treatments.
1. Ranibizumab (half-life: 9 days) requires a wash-out period of 45 days (7 weeks)
2. Aflibercept (half-life: 11 days) requires a wash-out period of 55 days (8 weeks)
3. Faricimab (half-life: 7.5 days) requires a wash-out period of 37.5 days (5 weeks)
4. Bevacizumab (half-life: 6 days) requires a wash-out period of 30 days (4weeks)
5. 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 hyperreflective material, or leakage).
6. BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
7. Decrease in BCVA determined to be primarily the result of nAMD or DR/DME in the study eye.
8. Presence of pigment epithelium detachment (PED), intraretinal fluid (IRF) and/or subretinal fluid (SRF) affecting the central subfield of the study eye on OCT.
9. 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 deemed not clinically significant by the investigators.
Exclusion Criteria:
1. Scar, fibrosis, atrophy, or retinal pigment epithelial tears involving the central fovea in the study eye.
2. Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with antiglaucoma medication) in the study eye.
3. History of idiopathic or autoimmune uveitis in the study eye.
4. Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
5. Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.
6. Uncontrolled blood pressure (defined as systolic \>160 mmHg or diastolic \>95 mmHg).
7. 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.
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