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Intravitreal conbercept at the end of diabetic vitrectomy for prevention of postoperative vitreous hemorrhage in proliferative diabetic retinopathy.

Intravitreal conbercept at the end of diabetic vitrectomy for prevention of postoperative vitreous hemorrhage in proliferative diabetic retinopathy.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015751
Enrollment
Unknown
Registered
2018-04-18
Start date
2018-04-23
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

diabetic retinopathy

Interventions

1:conbercept injection after surgery
2:no injection after surgery

Sponsors

Eye and ENT hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. signed the informed consent, and is willing to follow up according to the time stipulated in the test; 2. aged 18~70 years old; 3. target eyes must meet the following requirements: PDR surgical indications: 1) persist (1-3 months) vitreous hemorrhage; 2) TRD or RRD involved macular or threatened macula; 3) vitreous retinal adhesions caused by fibrous proliferation; vision 20/40 - HM/BE; HbA1c < 8% Note: if both of the patient's eyes met the inclusion criteria, the investigator identified the target eye from the medical angle.

Exclusion criteria

Exclusion criteria: 1. target eye has a history of vitrectomy surgery, or in this experiment, silicone oil was filled after surgery, or had been filled with gas or silicone oil for less than 6 months; 2. patients with uncontrollable hypertension (defined as after treatment, blood pressure is still greater than 150/95 mmHg); 3. coagulation function abnormity or recently (3 months) use anticoagulant medication, if aspirin is required to be stopped within 1 week before operation; 4. had an eye disease history of non-diabetic VH; 5. had received anti-VEGF treatment within 3 months and systemic anti-VEGF drugs were used within 6 months; 6. target eyes underwent eye surgery within 6 months; 7. target eyes were resected after the first vitreous surgery due to non-VH retinal disease; 8. systemic arterial thrombosis events such as cerebral apoplexy, myocardial infarction, etc.; 9. target eye infection (e.g. blepharitis, infectious conjunctivitis, keratitis, sclera, endophthalmitis) or repeated infection; 10. uncontrolled glaucoma (defined as the intraocular pressure after glaucoma treatment still > 25 mmHg), or optic disc ratio > 0.8, or target eyes underwent glaucoma filtration surgery; 11. aphakic (excluding intraocular lens) or posterior capsular rupture (except YAG laser after intraocular lens implantation); 12. tumor; 13. allergic to fluorescein sodium, allergic disease; 14. a history of surgery within one month and/or there were currently unhealed wounds, ulcers, fractures, etc. 15. affected by infectious diseases; 16. any uncontrolled clinical problems (such as HIV/AIDS, malignant tumor, active hepatitis, renal failure, serious mental, nervous, cardiovascular and respiratory system diseases, etc.); 17. has previously used drugs that may cause nephrotoxicity, including chloroquine, hydroxychloroquine, phenothiazine, chlorpromazine, thiopyridazine, fluorphenazine, perphenazine, and trifluorazine; 18. did not use effective contraceptives; Note: the following situations are not excluded. (1) In natural conditions, the level of the serum follicle stimulating hormone was 3 months, for five half-life) taken part in clinical trials of any drugs (not including vitamins and minerals); 21. researchers believe that they need to be excluded.

Design outcomes

Primary

MeasureTime frame
incidence of vitreous hemorrhage after operation;Time of clearance vitreous hemorrhage after operation;

Secondary

MeasureTime frame
Best corrected visual acuity;

Countries

China

Contacts

Public ContactChang Qing

Eye and ENT hospital, Fudan University

dr_changqing@126.com+86 21 64377134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026