EUCTR2011-001869-41-GB进行中（未招募）1 期
An exploratory study of ranibizumab (Lucentis) for treatment of uveitic patients with refractory cystoid macular oedema. 'The LIMO study' - Ranibizumab (Lucentis) for treatment of Uveitic Macular Oedema (LIMO)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
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