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

NCT01564108 | Completed Phase 2 DMC

• 1 other identifier: OKHN1005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Intravitreal Ranibizumab; Non-infectious uveitis; Refractory Cystoid Macular Oedema; Lucentis; LIMO

Outcome Measures

Primary Outcomes (2)

• The number of patients in whom, by consensus, no further treatment is required.

  Intravitreal Ranibizumab will be given at baseline, month 1 and month 2 . Subsequent 4-5 weekly injections will be given according to clinical need. There will be a total of 12 months of follow-up.

  Data will be collected at every patient visit which will take place every 4-5 weeks, and analysed at 12 months follow-up

• Change in CRT as measured by Spectralis spectral domain OCT.

  at baseline visit then at 6 and 12 months.

Secondary Outcomes (12)

• Functional vision changes based on self-reported quality of life measures (including acceptability of 4 weekly intravitreal therapy).

  at baseline visit then at 6 and 12 months.

• The proportion of subjects gaining >10 and >15 letters.

  at baseline vist, on day 7 and day 14, then on monthly basis.

• Change in contrast sensitivity.

  at baseline visit then at months 1, 3, 6, 9 and 12.

• Change in BCVA.

  at baseline visit then at 3, 6, 9 and 12 months.

• The proportion of subjects with loss of >15 letters and >30 letters.

  at baseline vist, on day 7 and day 14, then on monthly basis.

Study Arms (1)

Ranibizumab

EXPERIMENTAL

Series of intravitreal injections of Ranibizumab

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Series of intravitreal injections of Ranibizumab

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Other causes of macular oedema e.g. diabetic macular oedema etc.
• 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).
• Evidence of irreversible central visual loss
• Evidence of visually significant vitreo-retinal traction or epiretinal membrane on OCT.
• 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).
• History of cataract surgery within prior 6 months or cataract surgery anticipated within 6 months of starting the trial.
• Any anti-VEGF treatment to study eye within 4 months.
• Uncontrolled IOP \> = 24 mmHg (on topical IOP lowering medications).
• History of glaucoma.
• Patients with active or suspected ocular or periocular infections

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead
• Novartis: collaborator

Study Sites (1)

Moorfields Eye Hospital NHSFT Research and Treatment Centre

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Narciss Okhravi

  Moorfields Eye Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 27, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

GB (1)