A nationwide clinical trial for patients with the eye condition vitreous haemorrhage due to proliferative diabetic retinopathy investigating whether early eye surgery and laser treatment is a safe and better option for improving visual outcomes than the current standard of care

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17116576

Enrollment

250

Registered

2025-06-10

Start date

2026-01-02

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

Adults with type 1 or type 2 diabetes presenting with visual impairment due to vitreous haemorrhage secondary to proliferative diabetic retinopathy Eye Diseases

Interventions

Intervention: Early pars plana vitrectomy (PPV) with endolaser performed within 4 weeks (+5 days) of clinical decision for intervention. This will be followed by a standard of care pathway. Control

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults (>18 years) with type 1 or 2 diabetes, with visual impairment (defined as Snellen 6/12 or worse/ETDRS 73 letters or fewer) and with a diagnosis of vitreous haemorrhage secondary to proliferative diabetic retinopathy, and requiring intervention. 2. Treatment naïve and previous laser-treated patients.

Exclusion criteria

Exclusion criteria: 1. Previous surgery: history of PPV in the affected eye 2. Non-PDR VH caused by conditions unrelated to PDR 3. Other eye conditions: significant co-existing ocular pathology that might interfere with outcomes (e.g., advanced glaucoma, endophthalmitis) 4. Systemic conditions: any systemic condition preventing follow-up or compliance with the trial protocol

Design outcomes

Primary

Measure	Time frame
Best-corrected visual acuity (BCVA) is a key endpoint used to assess the effectiveness of treatments for visual impairments and eye diseases. For our patient population, this is measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale. BCVA will be assessed at 12 months.	—

Secondary

Measure	Time frame
1. Visual acuity changes over 12 months measured using ETDRS at baseline, 4 months, 8 months and 12 months and taking the area under the curve. 2. Patient-reported outcomes over 12 months measured using vision-related quality of life and satisfaction questionnaires taken at baseline and 12 months. 3. Rates of disease progression over 12 months measured using ophthalmic examinations (e.g., anterior and posterior eye segment examination and slit lamp) and imaging (e.g., colour fundus photographs and optical coherence tomography [OCT]) at baseline, 4 months, 8 months and 12 months. 4. Complications (e.g., recurrent VH, tractional retinal detachment, neovascular glaucoma) over 12 months measured using ophthalmic examinations (e.g., anterior and posterior eye segment examination and slit lamp) and imaging (e.g., colour fundus photographs and optical coherence tomography) at baseline, 4 months, 8 months and 12 months. 5. Hospital visit burden and additional treatments required (e.g., repeat PRP, intravitreal anti-VEGF injections, or further PPV) recorded from patient hospital visits over 12 months. 6. Macular ischaemia measured using OCT angiography at time 12 months. 7. Macular oedema and inner retinal thickness measured using OCT at time 12 months.	—

Measure

Time frame

1. Visual acuity changes over 12 months measured using ETDRS at baseline, 4 months, 8 months and 12 months and taking the area under the curve. 2. Patient-reported outcomes over 12 months measured using vision-related quality of life and satisfaction questionnaires taken at baseline and 12 months. 3. Rates of disease progression over 12 months measured using ophthalmic examinations (e.g., anterior and posterior eye segment examination and slit lamp) and imaging (e.g., colour fundus photographs and optical coherence tomography [OCT]) at baseline, 4 months, 8 months and 12 months. 4. Complications (e.g., recurrent VH, tractional retinal detachment, neovascular glaucoma) over 12 months measured using ophthalmic examinations (e.g., anterior and posterior eye segment examination and slit lamp) and imaging (e.g., colour fundus photographs and optical coherence tomography) at baseline, 4 months, 8 months and 12 months. 5. Hospital visit burden and additional treatments required (e.g., repeat PRP, intravitreal anti-VEGF injections, or further PPV) recorded from patient hospital visits over 12 months. 6. Macular ischaemia measured using OCT angiography at time 12 months. 7. Macular oedema and inner retinal thickness measured using OCT at time 12 months.

—

Countries

England, United Kingdom

Contacts

Public ContactMohammed Rupawala

mohammed.rupawala@nhs.net+44 (0)207 253 3411

Outcome results

None listed

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