Ranibizumab (Lucentis) for treatment of Uveitic Macular Oedema (LIMO)

Phase 1

Active, not recruiting

• Conditions: veitic Macular Oedema; MedDRA version: 20.1 Level: PT Classification code 10058202 Term: Cystoid macular oedema System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]; MedDRA version: 20.0 Level: PT Classification code 10046851 Term: Uveitis System Organ Class: 10015919 - Eye disorders

• Registration Number: EUCTR2011-001869-41-GB
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-14
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

General Inclusion Criteria
1.Age >= 18 years and less than 75 years
2.Diagnosis of uveitis of non-infectious origin
3.Able and willing to provide informed consent
4.Able and willing to attend for follow-up on Clinical Trial Unit, as per SOA

Study Eye Inclusion Criteria
The subject must have one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below.
1.Cystoid macular oedema (CMO) from non-infectious uveitis:
a.Unilateral or Bilateral CMO (the worse eye only will be treated with intravitreal Ranibizumab) in a quiet eye for = 1month
b.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’
c.Spectralis SD-OCT central subfield >=270 µm within 10 working days of study entry with uveitic macular oedema (cystoid or diffuse)
d.Quiet eye
i.as defined by 0-0.5 plus of cells in anterior chamber of the eye, and 0.5 or less vitreous haze (SUN classification)
ii.topical / systemic immunosuppressive treatment allowed but stable for 2 month with no resolution of CMO in a quiet eye for =1 month
iii.greater than 3 months since orbital steroid injection, 4 months since intravitreal triamcinolone treatment, or 8 weeks since starting new oral therapy
iv.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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

General Exclusion Criteria
1.Unstable cardiovascular disease or significant renal disease (defined as a history of chronic renal failure requiring dialysis or kidney transplant).
2.Known allergy to any component of the study drug.
3.Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). Patients with controlled systemic hypertension will be included. In all patients BP will be monitored and the primary care physician notified should systolic >150 and diastolic >90.
4.Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischaemic attack, or treatment for acute congestive heart failure or gastrointestinal ulceration or haemorrhage within 6 months prior to study entry.
5.Active ischaemia on ECG
6.Any anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
7.Pregnancy or lactating or intending to become pregnant within the next 12 months.

Study Eye Exclusion Criteria
1.Insufficient patient cooperation or media clarity to allow adequate fundus imaging.
2.Other causes of macular oedema e.g. diabetic macular oedema, juxtafoveal telangectasia etc
3.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)
4.Evidence of irreversible central visual loss
a.marked areas of decreased autofluorescence consistent with retinal atrophy, which would indicate that any improvement in visual acuity would be highly unlikely
b.central macular scarring
5.Evidence of visually significant vitreo-retinal traction or epiretinal membrane on OCT
6.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)
7.History of cataract surgery within prior 6 months or cataract surgery anticipated within 6 months of starting the trial
8.History of vitrectomy
9.Any anti-VEGF treatment to study eye within 4 months.
10.History of YAG capsulotomy performed within 2 months prior to randomization.
11.Aphakia.
12.Uncontrolled IOP > = 24 mmHg (on topical IOP lowering medications)
13.History of glaucoma.
14.A history of inherited retinal degeneration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does ranibizumab improve visual outcome in patients with uveitic macular oedema refractory or ineligible for 'standard of care' therapy?;Secondary Objective: Is intravitreal ranibizumab safe, efficacious and acceptable therapy in patients with uveitic macular oedema refractory or ineligible for 'standard of care' therapy?;<br> Primary end point(s): 1.The number of patients in whom, by consensus, no further treatment is required<br> 2.Change in central retinal thickness as measured by spectral domain OCT<br> ;Timepoint(s) of evaluation of this end point: Six and twelve months

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Efficacy:<br> - functional vision changes based on self-reported QoL measures<br> - proportion of subjects gaining >10 and >15 letters<br> - change in contrast sensitivity<br> - change in BCVA<br> - proportion of subjects with loss of >15 and >30 letters<br> - change in retinal sensitivity on microperimetry<br> - change in reading speed<br> - evidence of improvement in PERG or mfERG<br><br> Safety:<br> - maintenance of foveal avascular zone<br> - absence of toxicity on electrophysiological testing/microperimetry/autofluorescence<br> - incidence and severity of ocular and non-ocular adverse events<br> ;Timepoint(s) of evaluation of this end point: Six and twelve months