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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust
• Collaborator: Novartis
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

1. Cystoid macular oedema (CMO) from non-infectious uveitis:

• Unilateral or Bilateral CMO (the worse eye only will be treated with intravitreal Ranibizumab) in a quiet eye for 1month.

• On clinical exam and OCT, definite retinal thickening due to uveitic macular oedema involving the centre of the macula, refractory or ineligible for standard care.

• Spectralis SD-OCT central subfield >=270 μm within 10 working days of study entry with uveitic macular oedema (cystoid or diffuse).

• Quiet eye

• as defined by 0-0.5 plus of cells in anterior chamber of the eye, and 0.5 or less vitreous haze (SUN classification).

• topical / systemic immunosuppressive treatment allowed but stable for 2 month with no resolution of CMO in a quiet eye for 1 month.

• greater than 3 months since orbital steroid injection, 4 months since intravitreal triamcinolone treatment, or 8 weeks since starting new oral therapy

• at least 1 prior trial of oral, orbital or intravitreal steroid therapy for CMO or not eligible for steroid treatment (oral, orbital or intravitreal steroid) because IOP > 30 mmHg following such use in study eye or fellow eye (i.e. patient is a known steroid responder), at any time in the past.

2. Best corrected visual acuity in the study eye must be between 69 and 35 ETDRS letter score at 4m (Snellen equivalent of 6/12-6/60) within 10 working days of enrolment.

Exclusion Criteria:

1. Other causes of macular oedema e.g. diabetic macular oedema etc.

2. Presence of an ocular disease that in the opinion of the investigator is responsible for visual loss (e.g. sub-foveal atrophy, optic atrophy, dense subfoveal hard exudates).

3. Evidence of irreversible central visual loss

4. Evidence of visually significant vitreo-retinal traction or epiretinal membrane on OCT.

5. Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e. cataract would be reducing acuity to 6/12 or worse if eye was otherwise normal).

6. History of cataract surgery within prior 6 months or cataract surgery anticipated within 6 months of starting the trial.

7. Any anti-VEGF treatment to study eye within 4 months.

8. Uncontrolled IOP > = 24 mmHg (on topical IOP lowering medications).

9. History of glaucoma.

10. Patients with active or suspected ocular or periocular infections