NCT05268718

Au-Ag-Cu2O NG With PTT Anti Drug-resistant Microbial Keratitis

Status unknown EARLY_PHASE1 Last updated 7 March 2022

What this trial tests

EARLY_PHASE1 trial testing Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel in Keratitis, Ulcerative in 20 participants. Status unknown.

Timeline

1 August 2021

Primary endpoint
31 December 2023

1 July 2024

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	1 August 2021
Primary completion	31 December 2023
Estimated completion	1 July 2024
Sites	1 location across China

Drugs / interventions tested

• Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel — full drug profile →
• Voriconazole eye drops — full drug profile →
• Normal saline

Conditions studied

• Keratitis, Ulcerative — all drugs for Keratitis, Ulcerative →
• Antibiotic Resistance, Microbial — all drugs for Antibiotic Resistance, Microbial →
• Photothermal Therapy — all drugs for Photothermal Therapy →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 80, any sex, with Keratitis, Ulcerative or Antibiotic Resistance, Microbial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical study was conducted to evaluate the efficacy and safety of gold-silver cuprous oxide composite nanogels combined with photothermal therapy system in the treatment of severe drug-resistant bacterial keratitis ineffective by traditional antibiotic treatment in human eyes, and to provide translational applications. Based on the clinical evidence, a more effective and safe innovative treatment plan for corneal diseases has been developed.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hydrogels in the clinic: An update.
   Clegg JR, Adebowale K, Zhao Z, Mitragotri S. · · 2024 · cited 64× · PMID 39545079 · DOI 10.1002/btm2.10680
2. Nanoparticles incorporated hydrogels for delivery of antimicrobial agents: developments and trends.
   Ahmad N, Bukhari SNA, Hussain MA, Ejaz H, et al · · 2024 · cited 57× · PMID 38665493 · DOI 10.1039/d4ra00631c
3. Recent advances in the bench-to-bedside translation of cancer nanomedicines.
   Liu Y, Zhang Y, Li H, Hu TY. · · 2025 · cited 27× · PMID 40041906 · DOI 10.1016/j.apsb.2024.12.007
4. Recent Advances in Hydrogel-Based Phototherapy for Tumor Treatment.
   Gan S, Wu Y, Zhang X, Zheng Z, et al · · 2023 · cited 22× · PMID 37102898 · DOI 10.3390/gels9040286
5. Photothermal therapy of copper incorporated nanomaterials for biomedicine.
   Wang R, Huang Z, Xiao Y, Huang T, et al · · 2023 · cited 15× · PMID 38001505 · DOI 10.1186/s40824-023-00461-z
6. Bioresponsive engineered nanoparticles for immunomodulation.
   Hegde M, Mishra A, Banerjee R, Bintee B, et al · · 2025 · cited 4× · PMID 41162977 · DOI 10.1186/s12916-025-04305-6
7. Nanomedicine in the Fight Against Multidrug-Resistant Infections: A Review on Emerging Strategies and Translational Prospects.
   Ahmed N, Abusalah MAHA, Abuarqoub AH. · · 2025 · cited 3× · PMID 41098500 · DOI 10.2147/ijn.s547259
8. Clinical translation and landscape of stimuli-responsive nanomedicines and microscale therapeutics.
   Kobzev D, Kulyk O, Barmin RA, Tatarets A, et al · · 2026 · PMID 42210822 · DOI 10.1039/d6cs00165c