Clinical trial NCT01037348: Ranibizumab for the Treatment of Choroidal Neovascularisation (CNV) Secondary to Pathological Myopia (PM): an Individualized Regimen
Official title: A Phase II, Open-label, Multicentre, 12 Month Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5mg) in Patients With Choroidal Neovascularisation Secondary to Pathological Myopia (PM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Choroidal Neovascularisation
Keywords: Choroidal Neovascularisation
Pathological Myopia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to provide efficacy and safety data in patients with choroidal neovascularisation (CNV) secondary to myopia using an individualized as-needed (PRN) dosing schedule. Eligible patients who have provided written agreement to take part in the study will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. Following eye examinations and tests at monthly clinic visits, the study doctor will repeat the injections on a monthly basis as required for an additional 11 months, in accordance with specified retreatment criteria.

Patients will be in the study for approximately 12 months and will visit the hospital clinic 14 times over that period. The main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography and fluorescein angiography (FA), measurement of intraocular pressure, blood pressure and pulse measurements and completion of health-related questionnaires'.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients of any race, aged 18 years or older
* Diagnosis of active primary or recurrent subfoveal or juxtafoveal CNV secondary to PM
* Diagnosis of high myopia of at least -6 dioptres in the study eye spherical equivalent. For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye must have been at least -6 dioptres
* Patients who have a BCVA score between 78 and 24 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS)-like grading charts (approximately 6/9 - 6/96 Snellen equivalent)
* Patients must give fully informed consent and be willing and able to comply with all study procedures

Exclusion Criteria:

* History of any surgical intervention in the study eye within two months preceding screening
* Previous macular laser photocoagulation, treatment with intravitreal steroids, verteporfin with photodynamic therapy (Visudyne®) or anti-VEGF agents ranibizumab, bevacizumab or pegaptanib sodium (Macugen®) in the study eye
* Previous treatment with intravenously administered bevacizumab (Avastin®)
* Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
* History of allergic reaction to fluorescein
* Concurrent use of systemic anti-VEGF agents

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: The difference from baseline in mean Best Corrected Visual Acuity (BCVA)
timeFrame: 12 months
Secondary outcomes:
measure: Mean change in BCVA from baseline
timeFrame: 6 months
measure: Mean change in Central retinal Thickness (CRT) from baseline
timeFrame: 6 and 12 months
measure: Percentage of patients gaining ≥ 15 letters
timeFrame: 12 months
measure: Change in lesion size and morphology from baseline
timeFrame: 6 and 12 months
measure: Time to the first retreatment and the total number of treatments
timeFrame: 12 Months
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: City of London
country: United Kingdom
facility: Novartis Investigational Site
city: City of London
country: United Kingdom
facility: Novartis Investigative Site
city: City of London
country: United Kingdom
facility: Novartis Investigative Site
city: Frimley
country: United Kingdom
facility: Novartis Investigative Site
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Southampton
country: United Kingdom
facility: Novartis Investigative Site
city: Torquay
country: United Kingdom
facility: Novartis Investigative Site
city: Wolverhampton
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: Tufail A, Narendran N, Patel PJ, Sivaprasad S, Amoaku W, Browning AC, Osoba O, Gale R, George S, Lotery AJ, Majid M, McKibbin M, Menon G, Andrews C, Brittain C, Osborne A, Yang Y. Ranibizumab in myopic choroidal neovascularization: the 12-month results from the REPAIR study. Ophthalmology. 2013 Sep;120(9):1944-5.e1. doi: 10.1016/j.ophtha.2013.06.010. No abstract available.