EVERLAST
Research type
Research Study
Full title
A multicentre randomised clinical trial comparing the clinical efficacy and safety of early pars plana vitrectomy plus endolaser versus standard of care for visual impairment due to vitreous haemorrhage secondary to proliferative diabetic retinopathy
IRAS ID
357031
Contact name
Louisa Wickham
Contact email
ISRCTN Number
ISRCTN17116576
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
The most common cause of severe vision loss in people with diabetes is proliferative diabetic retinopathy (PDR). This condition affects about 3% of the UK population with diabetes, most being of working age. In PDR, the eye grows new blood vessels on the retina. The retina needs to be treated urgently by laser so that these blood vessels disappear or become inactive. If left untreated, these blood vessels can bleed into the vitreous region of the eye (termed vitreous haemorrhage [VH]) causing a sudden drop in vision and a delay to laser treatment. Nearly 50% of patients who develop PDR may still experience VH within 5 years despite good laser treatment. VH due to PDR is a global health problem that needs a new treatment strategy. The current Standard-of-Care (SoC) for patients involves:
1. A period of waiting for the bleeding to clear naturally, which usually lasts months.
2. Once the bleeding resolves, repeated laser treatments to prevent rebleeding.
3. If the blood does not clear sufficiently to apply laser treatment (about 20% of cases), the vitreous gel with blood is removed surgically (called vitrectomy) with laser treatment applied at the time of surgery. This procedure is typically offered after a long period of observation and several hospital appointments.
Clinical trials in the 1980s showed that patients with dense VH who underwent vitrectomy within 6 months had greater vision improvement, however, this approach was not recommended due to the risks of surgery. Since then, techniques and equipment for performing vitrectomy have advanced significantly reducing the risks of surgery.
This study aims to investigate whether for patients with VH due to PDR, early vitrectomy with laser treatment applied at the time of surgery is a safe and better option for improving visual outcomes, allowing faster visual rehabilitation, and reducing hospital appointments than the current SoC.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0172
Date of REC Opinion
6 Nov 2025
REC opinion
Further Information Favourable Opinion