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Clinical study of Oxervate on the individualized treatment effect in patients with diabetic keratopathy

Clinical study of Oxervate on the individualized treatment effect in patients with diabetic keratopathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058806
Enrollment
Unknown
Registered
2022-04-17
Start date
2022-04-15
Completion date
Unknown
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic keratopathy

Interventions

Treatment group:Oxervate eyedrops

Sponsors

Qingdao Eye Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Minimum age of 18 years old male or female; 2. Able, willing, and sufficient cognitive awareness to comply with examination procedures and study visits; 3. Able and willing to provide informed consent; 4. Diagnosis of Diabetic Keratopathy; 5. Actively diagnosed and being treated for Diabetes; 6. Patients failed to respond to other medications or surgery and were subsequently treated with rhNGF.

Exclusion criteria

Exclusion criteria: 1. According to the approved instructions, patients who are forbidden to be treated with Oxervate; 2. Also participate in clinical trials requiring other trial drugs; 3. Corneal scar has been produced, the use of this product with limited visual improvement; 4. Combined with history of brain surgery in patients or with postganglionic injury; 5. Patients with systemic immune diseases (e.g. Sjogren's syndrome, rheumatoid arthritis, ankylosing spondylitis, etc.); 6. Current pregnancy or nursing; 7. Corneal Refractive Surgery in the past 6 months; 8. Corneal cross-linking in the past 4 months.

Design outcomes

Primary

MeasureTime frame
Slit-lamp;Sodium fluorescein staining;Corneal sensitivity;Corneal nerve density;

Secondary

MeasureTime frame
Shirmer test I;Layer gland score;Breakup time of tears;RT-OCT;Glycosylated hemoglobin;

Countries

China

Contacts

Public ContactXie Lixin

Qingdao Eye Hospital of Shandong First Medical University

fff993541@163.com+86 18866255751

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026