Ranibizumab for the Treatment of Choroidal Neovascularisation (CNV) Secondary to Pathological Myopia (PM): an Individualized Regimen

Choroidal Neovascularisation Clinical Trial

— REPAIR  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037348
• Other study ID #: CRFB002AGB10
• Secondary ID: 2009-014854-14
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2009
• Last updated: April 15, 2016
• Start date: January 2010
• Est. completion date: May 2012

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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'.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularisation
• Choroidal Neovascularization
• Myopia, Degenerative
• Neovascularization, Pathologic

Intervention

Drug:
• ranibizumab 0.5mg

Locations

Country	Name	City	State
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigational Site	City of London
United Kingdom	Novartis Investigative Site	City of London
United Kingdom	Novartis Investigative Site	City of London
United Kingdom	Novartis Investigative Site	Frimley
United Kingdom	Novartis Investigative Site	Leeds
United Kingdom	Novartis Investigative Site	Newcastle Upon Tyne
United Kingdom	Novartis Investigative Site	Nottingham
United Kingdom	Novartis Investigative Site	Southampton
United Kingdom	Novartis Investigative Site	Torquay
United Kingdom	Novartis Investigative Site	Wolverhampton
United Kingdom	Novartis Investigative Site	York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference from baseline in mean Best Corrected Visual Acuity (BCVA)		12 months	No
Secondary	Mean change in BCVA from baseline		6 months	No
Secondary	Mean change in Central retinal Thickness (CRT) from baseline		6 and 12 months	No
Secondary	Percentage of patients gaining = 15 letters		12 months	No
Secondary	Change in lesion size and morphology from baseline		6 and 12 months	No
Secondary	Time to the first retreatment and the total number of treatments		12 Months	No