A phase III clinical trial of rat nerve growth factor injection in the treatment of wounded optic nerve

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13004103

Enrollment

Unknown

Registered

2013-12-16

Start date

2013-12-19

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

optic nerve injury

Interventions

Treatment:Rutine treatment + rat nerve growth factor

control:Rutine treatment +placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-70 years; 2. both male and female; 3. Patients with optic nerve injury; 4. To be wounded within two months; 5. Corrected visual acuity 0.05- <=0.6; 6. The eyeball without canalization injury, refraction media transparency; 7. Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. younger than 18 years old or older than 70 years old; 2. To be wounded more than 2 months; 3. Pregnacy or in the feeding period woman; 4. Hypersensitivity for the test drug; 5. Patient with other eye problems such as obvious retina vitreous diseases,hyphema,secondary glaucoma and so on; 6. Patient with optic canal fracture or intracranial hemorrhage; 7. Reflect media opacity or lens dislocation; 8. Intraocular pressure >=24mmHg; 9. Patients who treated by internal ophthal operation or leiser operation in last three months; 10. Patients with unnormal liver or kidney function or within the limitation but clinical significance was diagnosed by investigators; 11. Patients with severe heart, visual system, liver, kidney, alimentary tract or blood system diseases, diabetes, hypertention (blood pressure >=180/110mmHg); 12. Attended other clinical studies in last three months; 13. Patients with severe mental or language disfunction unable to complete the treatment protocol; 14. Used other nerve nutrition drugs or drugs which may disturb the trial in 14 days; 15. Attended rehabilitations such as hyperbaric oxygen therapy or acupuncture; 16. The other eye with visual acuity <0.05; 17. Patients who are not considered to be suitable for the study with other reasons by investigators.

Design outcomes

Primary

Measure	Time frame
The best corrected visual acuity;Effect scores;	—

Secondary

Measure	Time frame
Visual field defect scores;VEP;	—

Countries

China

Contacts

Public ContactNingli Wang

Xiamen Bioway Biotech CO., Ltd.

wningli@vip.163.com+86 010 58269920

Outcome results

None listed

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