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A prospective and randomized controlled clinical study for pre- and after-operative intravitreal injection of anti-VEGF combined with pars plana vitrectomy

A prospective and randomized controlled clinical study for pre- and after-operative intravitreal injection of anti-VEGF combined with pars plana vitrectomy in the treatment of proliferative diabetic retinopathy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029884
Enrollment
Unknown
Registered
2020-02-16
Start date
2020-02-20
Completion date
Unknown
Last updated
2020-02-17

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

Conditions

proliferative diabetic retinopathy

Interventions

control group:preoperative intravitreal injection of anti-VEGF combined with vitrectomy
experimental group:after-operative intravitreal injection of anti-VEGF combined with vitrectomy

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged >=18 years old with diabetes mellitus (type 1 or type 2), newly diagnosed as proliferative diabetic retinopathy, with retinal traction detachment or continuous vitreous hemorrhage and never received PPV before; 2. The visual acuity of the taget eyes must be attributed to severe PDR; 3. The best corrected visual acuity of ETDRS was 0-73 letters; 4. Be willing to participate in the clinical experiment and sign the informed consent form; 5. Be willing to follow up according to the protocol.

Exclusion criteria

Exclusion criteria: 1. Systemic diseases are not controlled; 2. Patients who have severe PDR with extensive retinal plica, requiring retinotomy or have extensive retinal traction detachment or retinal hole; 3. Patients who have received systemic anti VEGF or VEGF treatment within 4 months before randomization; 4. Patients who have other serious eye diseases besides DR, such as uveitis, retinal vascular changes, congenital and traumatic vitreoretinopathy; 5. Patients who have are contraindications to PPV, such as severe hypertension, poor blood glucose control, abnormal liver and kidney function, allergic anesthesia and other general conditions are not allowed; 6. Patients who have are contraindications to anti VEGF drugs, such as active infection of the eye or periocular and active endophthalmitis; 7. The postoperative follow-up time was less than 2 times or patients who can not follow up as required; 8. Patients who had participated in other clinical trials within 3 months before the group was enrolled.

Design outcomes

Primary

MeasureTime frame
BCVA;

Secondary

MeasureTime frame
Time from entering the study to completly removal of vitreous hemorrhage;central foveal thickness;convenience of pars plana vitrectomy;Adverse events recorded during treatment;vitreous hemorrhage;

Countries

China

Contacts

Public ContactQinghua Qiu

Shanghai General Hospital

qiuqh9@163.com+86 13386259756

Outcome results

None listed

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