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Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment

NCT ID: NCT01257815

Last Updated: 2014-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-04-30

Brief Summary

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This study evaluates a new investigational treatment regimen of three consecutive monthly doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for the first three months then two-monthly follow-up until 18 months in patients with visual impairment due to diabetic macular oedema.The aim of the study is to determine if this treatment regimen is effective and safe in these patients.

Detailed Description

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Conditions

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Diabetic Retinopathy Macular Oedema

Keywords

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Diabetes mellitus Diabetic retinopathy Macular oedema Visual acuity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ranibizumab 0.5mg

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

Interventions

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Ranibizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with Type 1 or Type 2 diabetes mellitus.
* Patients with visual impairment due to focal or diffuse diabetic macular oedema (DMO), and not other causes, in at least one eye who are eligible for laser treatment in the opinion of the investigator.
* Best Corrected Visual Acuity between 78 and 24 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS)-like grading charts (approximate Snellen equivalent of 20/32 to 20/320).
* Increased central retinal thickness which, in the opinion of the investigator, is due to DMO.

Exclusion Criteria

* Concomitant conditions in the study eye that could prevent the improvement of visual acuity on study treatment.
* Active intraocular inflammation (grade trace or above) or infection in either eye at enrollment.
* History of uveitis in either eye at any time.
* Structural damage within 0.5 disc diameters of the centre of the macular in the study eye likely to preclude improvement in visual acuity following resolution of macular oedema.
* Planned medical or surgical intervention during the 18-month study period.
* Uncontrolled glaucoma in either eye at screening.
* Blood pressure systolic \> 160 mmHg or diastolic \> 100 mmHg at screening.
* Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids.
* History of acute thromboembolic event within 4 months of screening.
* Untreated diabetes mellitus.
* Evidence of advanced, severe or unstable concomitant disease or its treatment which may interfere with evaluations or put the patient at special risk.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Torquay, Devon,, United Kingdom

Site Status

Novartis Investigative Site

Hull, Hull, United Kingdom

Site Status

Novartis Investigative Site

Ayr, , United Kingdom

Site Status

Novartis Investigative Site

Belfast, , United Kingdom

Site Status

Novartis Investigative Site

Birmingham, , United Kingdom

Site Status

Novartis Investigative Site

Cardiff, , United Kingdom

Site Status

Novartis Investigative Site

Colchester, , United Kingdom

Site Status

Novartis Investigative Site

Fife, , United Kingdom

Site Status

Novartis Investigative Site

Great Yarmouth, , United Kingdom

Site Status

Novartis Investigative Site

Liverpool, , United Kingdom

Site Status

Novartis Investigative Site

London, , United Kingdom

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Novartis Investigative Site

London, , United Kingdom

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Novartis Investigative Site

Rugby, , United Kingdom

Site Status

Novartis Investigative Site

Uxbridge, , United Kingdom

Site Status

Novartis Investigative Site

York, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Pearce I, Banerjee S, Burton BJ, Chakravarthy U, Downey L, Gale RP, Gibson J, Pagliarini S, Patel J, Sivaprasad S, Andrews C, Brittain C, Warburton J; RELIGHT Study Group. Ranibizumab 0.5 mg for Diabetic Macular Edema with Bimonthly Monitoring after a Phase of Initial Treatment: 18-Month, Multicenter, Phase IIIB RELIGHT Study. Ophthalmology. 2015 Sep;122(9):1811-9. doi: 10.1016/j.ophtha.2015.05.038. Epub 2015 Jul 3.

Reference Type DERIVED
PMID: 26150052 (View on PubMed)

Other Identifiers

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2010-022616-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRFB002DGB14

Identifier Type: -

Identifier Source: org_study_id