NCT01564108

The LIMO Study, Lucentis for Treatment of Uveitic Patients With Refractory Cystoid Macular Oedema

An Exploratory Study of Ranibizumab (Lucentis) for Treatment of Uveitic Patients With Refractory Cystoid Macular Oedema Which Has Proven Refractory or Ineligible to Standard Treatment.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Moorfields Eye Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Anti-vascular endothelial growth factor (VEGF) treatments show great promise in the treatment of a variety of retinal diseases. This study addresses a condition which affects a large number of our patients in whom the investigators face difficult management decisions. These patients with uveitis are severely disabled with visual loss related to cystoid macular oedema (CMO) and few options remain when standard treatment has either failed or is contraindicated. The concentration of VEGF is increased in the eyes of patients with uveitis. Our hypothesis is that a series of injections of Ranibizumab may be an effective treatment for CMO. It is hoped that anti-VEGF therapy will have fewer side-effects than existing therapies and will be more effective in improving quality of life by reducing macular thickening and restoring visual function.

Detailed description

The study has been designed as an open label, prospective non-randomised interventional case series. Clinical staff will be asked to briefly discuss the option of enrolling into the study with potentially suitable patients. If the patient expresses an interest in finding out more about the study, the doctor will then contact a member of the study team, who will provide the patient with the patient information leaflet. This outlines the details and purpose of the study, the intended benefits of the intravitreal treatment and the potential hazards (including the unlicensed use of Ranibizumab for this indication). The intravitreal injection procedure will be discussed. The follow-up schedule will be outlined. There will be an opportunity for the patient to ask questions and at least 24 hours for the patient to think about entering the study. Only 1 eye of each patient, the worse eye, will be enrolled. Comprehensive pre- and post- therapy and a longitudinal series of structure and function tests will be performed on all 20 enrolled patients. All patients will receive intravitreal injections performed in a designated clean room. The injections (Ranibizumab 0.5 mg in 0.05 ml) will be administered 4-5 weekly, for three injections then according to clinical need for a total of 12 months of follow-up. A maximum of 5 intravitreal Ranibizumab injections will be administered to patients who do not demonstrate any positive clinical response. The patients will be seen for baseline screening over a 2 day period, with the first treatment with Ranibizumab administered on the second day (maximum of 10 working days after the first baseline screening day). Subsequent to the first 3 injections, the investigator will assess whether re-treatment is warranted (clinical / OCT criteria set out in re-treatment protocol). Re-treatment, when indicated, will be performed on the same day as the follow-up visit and no sooner than 4 weeks or later than 5 weeks from the time of the last treatment. If re-treatment with IVI Ranibizumab is to be deferred patients will not be given a sham injection. Should a relapse in ocular inflammation occur, it might be difficult to differentiate as to whether this is because of the drug or the underlying disease. A mild flare up, Lucentis-related or not, may be observed and treated with topical therapy (but patient will remain in the study). A moderate to severe recurrence, regardless of the cause which will necessitate more extensive therapy, namely a change or addition of systemic therapy, will result in the patient exiting the study-this would be an end point.

Conditions

• Uveitis Related Cystoid Macular Edema
• Steroid-induced Glaucoma - Borderline

Interventions

Type	Name	Description
DRUG	Ranibizumab	Series of intravitreal injections of Ranibizumab

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-03-27
• Last updated: 2019-03-27

Locations

1 site across 1 country: United Kingdom