Clinical trial NCT01257815: Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Retinopathy
Macular Oedema
Keywords: Diabetes mellitus
Diabetic retinopathy
Macular oedema
Visual acuity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-12-10
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The change in mean Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: The change in mean Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline to 18 months
measure: Occurrence of ocular and systemic adverse events
timeFrame: Baseline to 18 months
measure: Time course of changes in BCVA
timeFrame: From 6 to 12 and 18 months
measure: Time course of changes in central retinal thickness
timeFrame: From baseline and 6 months to 12 and 18 months
measure: Proportion of patients with 10 and 15 letter improvement or loss in BCVA
timeFrame: From baseline to 12 and 18 months
Other outcomes:
Locations:
city: Torquay
country: United Kingdom
facility: Novartis Investigative Site
state: Devon,
city: Ayr
country: United Kingdom
facility: Novartis Investigative Site
city: Belfast
country: United Kingdom
facility: Novartis Investigative Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Cardiff,
country: United Kingdom
facility: Novartis Investigative Site
city: Colchester
country: United Kingdom
facility: Novartis Investigative Site
city: Fife
country: United Kingdom
facility: Novartis Investigative Site
city: Great Yarmouth
country: United Kingdom
facility: Novartis Investigative Site
city: Hull
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Rugby
country: United Kingdom
facility: Novartis Investigative Site
city: Uxbridge
country: United Kingdom
facility: Novartis Investigative Site
city: York
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.