Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangdong ProCapZoom Biosciences Co., Ltd.

About this trial

This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.

Eligibility criteria

Qualifiers

Aged 18-65 years old, including the boundary value, no gender restriction;

Subjects meeting the 2016 ACR/EULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement.

The ocular involvement symptoms and signs of these patients cannot be relieved after at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids.

Extra-ocular manifestations of Sjögren's syndrome clinically stable.

Disqualifiers

Known allergy to any component of the investigational drug.

Active ocular infection.

Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns.

History of any ocular surgery within the preceding 6 months, including cataract surgery.

Trial design

Treatments tested in this trial

  • Exosome Preparation

Treatment groups

12 Participants
are divided into 1 treatment group

Locations

This trial has no locations