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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01257815

Collaborator

(none)

111

Enrollment

Locations

Arm

Duration (Months)

7.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy Macular Oedema	Drug: Ranibizumab	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment. A UK, 18-month, Prospective, Open-label, Multicentre, Single-arm, Phase IIIb Study With 12-month Primary Endpoint, Assessing the Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Diabetic Macular Oedema.

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ranibizumab 0.5mg	Drug: Ranibizumab

Arm

Intervention/Treatment

Experimental: Ranibizumab 0.5mg

Drug: Ranibizumab

Outcome Measures

Primary Outcome Measures

The change in mean Best Corrected Visual Acuity (BCVA) [Baseline to 12 months]

Secondary Outcome Measures

The change in mean Best Corrected Visual Acuity (BCVA) [Baseline to 18 months]
Occurrence of ocular and systemic adverse events [Baseline to 18 months]
Time course of changes in BCVA [From 6 to 12 and 18 months]
Time course of changes in central retinal thickness [From baseline and 6 months to 12 and 18 months]
Proportion of patients with 10 and 15 letter improvement or loss in BCVA [From baseline to 12 and 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Torquay	Devon,	United Kingdom	TQ2 7AA
2	Novartis Investigative Site	Ayr		United Kingdom	KA6 6DX
3	Novartis Investigative Site	Belfast		United Kingdom	BT12 6BA
4	Novartis Investigative Site	Birmingham		United Kingdom	B9 5SS
5	Novartis Investigative Site	Cardiff,		United Kingdom	CF14 4XW
6	Novartis Investigative Site	Colchester		United Kingdom	CO3 3NB
7	Novartis Investigative Site	Fife		United Kingdom	KY12 OSU
8	Novartis Investigative Site	Great Yarmouth		United Kingdom	NR31 6LA
9	Novartis Investigative Site	Hull		United Kingdom	HU3 2JZ
10	Novartis Investigative Site	Liverpool		United Kingdom	L7 8XP
11	Novartis Investigative Site	London		United Kingdom	E11 1NR
12	Novartis Investigative Site	London		United Kingdom	SE5 9RS
13	Novartis Investigative Site	Rugby		United Kingdom	CV22 5PX
14	Novartis Investigative Site	Uxbridge		United Kingdom	UB8 3NN
15	Novartis Investigative Site	York		United Kingdom	YO31 8HE