A multicentre randomised clinical trial comparing the clinical efficacy and safety of early vitrectomy plus endolaser versus standard of care for visual impairment due to vitreous haemorrhage secondary to proliferative diabetic retinopathy (EVERLAST)

RESEARCH QUESTION In people with visual impairment due to vitreous haemorrhage (VH) due to proliferative diabetic retinopathy (PDR), does early vitrectomy and endolaser as a primary intervention result in better visual outcomes compared to the usual care of repeated panretinal photocoagulation (PRP) as the haemorrhage clears and vitrectomy done only for non-clearing VH or other complications? BACKGROUND Patients with PDR with visual impairment due to VH can experience delayed visual rehabilitation and visual loss despite current standard of care. The current standard of care is to perform repeated PRP as soon as the VH has cleared and vitrectomy and endolaser is reserved for non-clearing VH despite at least four months of observation. Vitrectomy and endolaser is often delayed for months, in some cases even over a year, especially in recurrent VH, to allow for spontaneous absorption of VH. There is a need to investigate alternate interventions and models of care for this condition to facilitate early visual rehabilitation. As vitrectomy is a safer procedure due to advances in ocular microsurgical instruments and techniques today than decades ago when the first trials on vitrectomy were done for VH due to PDR, early vitrectomy may result in early visual rehabilitation and better visual outcomes. AIMS The primary aim of this research is to determine whether early vitrectomy with endolaser is superior to standard of care in terms of visual outcome at 12 months. The secondary aims are to evaluate the visual outcome over 12 months, safety of early vitrectomy and endolaser for this indication, changes in eye health, rates of complications, need of additional treatments, quality of life and patient satisfaction at 12 months. METHODS Multi-centre (25 retinal clinics within NHS hospitals), parallel group, 1:1 randomised, outcome assessor masked, superiority trial with an internal pilot, comparing early vitrectomy and endolaser within four weeks of presentation with visual impairment of Snellen VA 6/12 or worse due to VH related to PDR, versus standard of care of repeated PRP if media permits and reserving vitrectomy for non-clearing haemorrhage and other complications such as retinal detachment. 250 adults with either type 1 or 2 diabetes with visual impairment due to VH due to PDR will be recruited on the trial. TIMELINES OF DELIVERY A pilot will take place over 6 months following a 6-month period of set-up (feasibility stage). This pilot stage will ensure that a minimum of 7 centres are recruiting with a minimum recruitment of 20% (a traffic light system will be used to monitor progress). The main study recruitment period will continue for a further 12 months. Total recruitment period will be 18 months (across 25 sites) with a 12-month patient follow-up period. A final 6 months will be dedicated to data analysis, and dissemination. IMPACT AND DISSEMINATION Positive results will indicate a safe and efficacious treatment for VH due to PDR. Neutral results, or finding major safety issues, will be of direct relevance to ophthalmologists globally. Results will inform NICE and other diabetic retinopathy guidelines, be published in high impact open-access journals and be rapidly communicated to interested participants, vision and diabetes related charities.