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

Novartis

Status and phase

Completed

Phase 2

Conditions

Choroidal Neovascularisation

Treatments

Drug: ranibizumab 0.5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01037348

2009-014854-14 (EudraCT Number)

CRFB002AGB10

Details and patient eligibility

About

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'.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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