Evaluating the best timing for anti-VEGF treatment before surgery in diabetic eye disease
A Randomized Controlled Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA
This study is testing the best timing for giving a specific eye treatment before surgery in people with diabetic eye disease to see which timing works best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sichuan Provincial People's Hospital Academic / other |
| Locations | 1 site (Chendu, Sichuan) |
| Trial ID | NCT06300918 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the optimal timing for administering anti-VEGF drugs prior to surgery in patients with proliferative diabetic retinopathy (PDR). Participants will be randomly assigned to receive the treatment at three different time points: 3 days, 7 days, or 14 days before surgery. The study utilizes advanced fluorescein fundus angiography during the operation to assess the effectiveness of the treatment in inhibiting fundus neovascularization. By comparing the outcomes across these groups, the trial seeks to identify the most effective timing for intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with type 1 or type 2 diabetes diagnosed with proliferative diabetic retinopathy and specific eligibility criteria.
Not a fit: Patients with prior vitreoretinal surgery, recent intravitreal drug injections, or other significant eye diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and vision preservation for patients with proliferative diabetic retinopathy.
How similar studies have performed: While studies have confirmed the effectiveness of anti-VEGF drugs in treating PDR, this specific timing approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PDR is diagnosed in people 18 years of age or older with type 1 or type 2 diabetes， * Hemoglobin A1c (HbA1c) ≤10% * Persistent vitreous hemorrhage for more than one month or recurrent vitreous hemorrhage (within six months) * Did not undergo retintis photocoagulation (PRP) * Vitreous hemorrhage disease course within six months Exclusion Criteria: * Patients who have had previous vitreoretinal surgery * Intravitreal drug injection within 3 months * Eye diseases other than PDR that may hinder vision improvement, such as optic atrophy or macular hole * Thromboembolic events (including cerebrovascular or myocardial infarction) or clotting system disorders or receiving anticoagulation or antiplatelet therapy * B-ultrasound or indirect fundus microscopy showing retina detachment (pull or hole origin) * Vitrectomy, FFA contraindicated patients, patients with severe abnormality of cardiopulmonary, liver and kidney function
Where this trial is running
Chendu, Sichuan
- Sichuan Academy of Medical Science Sichuan Provincial Hosptial — Chendu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Jie Li, doctor
- Email: lijieyk@med.uestc.edu.cn
- Phone: +86 139 0809 4675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.