{"type":"trials","record":{"id":41550,"source_id":"clinicaltrials-gov","external_id":"NCT07547228","title":"A Study of PRL3-zumab in Neovascular Age-related Macular Degeneration (nAMD)","brief_summary":"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 Investigator. Primary Endpoints: 1. Safety: • Adverse Events: Frequency and severity of adverse events throughout the primary outcome assessment period will be assessed by the Investigator for severity according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 or later 2. RP2D: • This study will confirm Recommended Phase 2 DOse (RP2D) established from Phase I Clinical Trial in Cancer patients conducted in National University Hospital Singapore (MC/03/0616). 3. Efficacy: * Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score. Change in BCVA letter gain of 0-4 will be considered as primary end point. * Change From Baseline in Central Subfield Retinal Thickness (CST) measured by Optical Coherence Tomography (OCT). \\[Assessment Time Frame: 4 weekly through 24 weeks\\] Secondary endpoints: * Change in visual Acuity (Best Corrected Visual Acuity) of 5 or more letters. * Proportion of patients gaining ≥15, ≥10, ≥5, or ≥0 ETDRS letters in BCVA from baseline over time * Proportion of patients avoiding a loss of ≥15, ≥10, or ≥5 ETDRS letters in BCVA from baseline over time * Proportion of patients with absence of intraretinal fluid measured by OCT * Proportion of patients with absence of subretinal fluid measured by OCT \\[Assessment Time Frame: 4 weekly through 24 weeks\\] Criteria for additional Therapy: Once the treatment is stopped after the third dose, patients from all groups are eligib…","overall_status":"Recruiting","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Intra-IMMUSG Pte Ltd","enrollment":15,"countries":["Singapore"],"start_date":"2025-10-11","completion_date":"2027-07-07","last_update_date":"2026-04-29","source_url":"https://clinicaltrials.gov/study/NCT07547228","editorial_summary":"A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"18 Years","comparator":"Group 3: Placebo","organization":"Intra-IMMUSG Pte Ltd","interventions":["PRL3-ZUMAB","Normal Saline (0.9% Sodium Chloride)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Safety: Adverse Events according to CTCAE — 24 weeks","Recommended Phase 2 Dose (PR2D) — 24 weeks","Efficacy: Best Corrected Visual Acuity (BCVA) measured by ETDRS letter score — 24 weeks","Efficacy: Subfield Retinal Thickness (CST) measured by Optical Coherence Tomography (OCT) — 24 weeks","Best Corrected Visual Acuity (BCVA) measured by ETDRS letter score — 24 weeks","Intraretinal fluid measured by Optical Coherence Tomography (OCT) — 24 weeks","Subretinal fluid measured by Optical Coherence Tomography (OCT) — 24 weeks"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Neovascular Age Related Macular Degeneration","PRL3-ZUMAB","Normal Saline (0.9% Sodium Chloride)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct07547228","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-10-11 to 2027-07-07","comparator":"Group 3: Placebo","confidence":"structured-source","population":"ALL · 18 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.832Z","intervention":["PRL3-ZUMAB","Normal Saline (0.9% Sodium Chloride)"],"participants":15,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1, PHASE2","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Safety: Adverse Events according to CTCAE — 24 weeks","Recommended Phase 2 Dose (PR2D) — 24 weeks","Efficacy: Best Corrected Visual Acuity (BCVA) measured by ETDRS letter score — 24 weeks","Efficacy: Subfield Retinal Thickness (CST) measured by Optical Coherence Tomography (OCT) — 24 weeks","Best Corrected Visual Acuity (BCVA) measured by ETDRS letter score — 24 weeks","Intraretinal fluid measured by Optical Coherence Tomography (OCT) — 24 weeks","Subretinal fluid measured by Optical Coherence Tomography (OCT) — 24 weeks"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Title contains controlled term: age-related macular degeneration.","Abstract contains controlled term: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41550","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}