Ophthalmology research

Quality of Life in Glaucoma – Quality of life assessment in glaucoma patients undergoing glaucoma surgery

Principal Investigator – Ms Joanna Liput

Sponsor – Nottingham University Hospitals NHS Trust

This observational study is open to all patients who are referred for surgery (e.g. trabeculectomy) to treat their advanced glaucoma. Patients are asked to complete questionnaires to assess how the surgery may affect their long-term quality of life. It monitors patients from pre-surgery until up to 10 years post-operatively.

Please contact the Research Team or speak to your glaucoma specialist for further information.

FASBAT – Observing fibrosis, macular atrophy and sub retinal highly reflective material before and after intervention with anti-VEGF treatment – an extension to the EDNA Study

Principal Investigator – Mrs Sarah Mackenzie

Sponsor – York Teaching Hospitals NHS Foundation Trust

The FASBAT study is following participants who have recently been diagnosed with wet AMD that have already been recruited to the EDNA study.

Patients with wet AMD in one eye have an increased risk of developing the condition in their second eye. The EDNA and FASBAT studies will observe the same patient population, monitoring disease progression and collecting important data.

The patient exit point of the EDNA study is when wet AMD is detected in the second eye and participants will then be monitored for a further two years as part of the FASBAT extension study.

The main aim of FASBAT is to compare the pre- and post-treatment structural changes that have occurred in both eyes. It is also assessing the effects of treatment on patients’ vision and quality of life.

EDNA – Early Detection of Neovascular Age Related Macular Degeneration

Principal Investigator – Mrs Sarah Mackenzie

Sponsor – Queen’s University Belfast

An observational study investigating which tests are most effective in detecting the first signs of development of “wet” (or neovascular) age-related macular degeneration. Wet AMD is a condition affecting the macula (the central part of the retina of the eye) which can cause irreversible sight loss if not treated promptly, therefore detecting it early and starting treatment as soon as possible is important to help prevent sight loss.

Patients were invited to join EDNA if they had recently developed wet AMD in one eye. The study monitors their dry (second) eye for early signs of wet AMD using standard diagnostic tests along with the patient’s own assessment of how they feel their vision is. Follow-up for EDNA stops either at 3 years after recruitment or when a patient develops wet AMD in the second eye.

TAGS – Treatment of Advanced Glaucoma Study

Principal Investigator – Ms Joanna Liput

Sponsor – Nottingham University Hospitals NHS Trust

This trial is comparing primary medical treatment (eye drops) with primary trabeculectomy surgery for people with newly diagnosed advanced glaucoma.

Both treatments are commonly and successfully used in the NHS to reduce eye pressure but it is not known which treatment is better for patients’ quality of life or which is most successful over the long term in preserving patients’ eyesight and preventing further vision loss.

The study is designed to find out which treatment patients prefer in terms of their quality of life. Patients are randomised to have either eye drops or surgery and are then followed up for 2 years as part of TAGS.

LEAVO – A Multicentre Phase III Double-masked Randomised Controlled Non-Inferiority Trial comparing the clinical and cost effectiveness of intravitreal therapy with ranibizumab (Lucentis) vs aflibercept (Eylea) vs bevacizumab (Avastin) for Macular Oedema due to Central Retinal Vein Occlusion

Principal Investigator – Mrs Sarah Mackenzie

Sponsor – Moorfields Eye Hospital

LEAVO is assessing whether Avastin and Eylea are as effective and economical as Lucentis in improving visual function in macular oedema due to central retinal vein occlusion (CRVO).

Patients were randomised to one of the three treatments and, as the study was double-masked, neither the participant nor the research team knew which drug they were receiving. Patients were followed up for 2 years as part of LEAVO and then continued their treatment in standard care.

Closed to recruitment

December 2016

Follow-up finished at HDFT but ongoing nationally.

SAFARI – Study in patients with neovascular Age-related macular degeneration (nAMD), evaluating the efficacy and safety of switching from intravitreal Aflibercept (Eylea) to Ranibizumab (Lucentis)

Principal Investigator – Mr Gavin Walters

Sponsor – Novartis

This study recruited patients with neovascular (wet) AMD who had responded sub-optimally to treatment with Eylea. Patients were switched to treatment with Lucentis and monitored for 6 months. SAFARI aimed to assess the safety and efficacy of this change in treatment.

January 2017

CONSTANCE – Post-Authorisation Safety Study of Ozurdex (Dexamethasone Intravitreal Implant) in patients with Macular Oedema secondary to Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO)

Principal Investigator – Mr Gavin Walters

Sponsor – Allergan

A prospective observational study to evaluate the long-term safety of Ozurdex in real-world clinical practice.

Patients being treated with Ozurdex for CRVO or BRVO as part of standard care were invited to join CONSTANCE. Their medical data was then collected regularly over a 2 year follow-up period.

September 2015

INJECT – Investigation of JETREA (ocriplasmin 0.125 mg) in Patients with Confirmed Vitreomacular Traction

Principal Investigator – Mr Gavin Walters

Sponsor – Alcon Research Ltd

An observational study evaluating the safety, clinical effectiveness and health-related quality of life outcomes of JETREA in a real-world setting among a large population of patients with vitreomacular traction (VMT)

Patients treated with JETREA for VMT were eligible to be part of the INJECT study. Data was collected during the course of routine VMT treatment and follow-up. Participants were monitored for 12 months and completed 4 Visual Functioning Questionnaires during this time.

September 2016