A phase II, open-label, multicentre, 12 month study to evaluate the efficacy and safety of ranibizumab (0.5 mg) in patients with choroidal neovascularization secondary to pathological myopia (PM) - REPAIR
- Conditions
- Choroidal neovascularisation (CNV) secondary to pathological myopia (PM)MedDRA version: 13.1 Level: PT Classification code 10060823 Term: Choroidal neovascularisation System Organ Class: 10015919 - Eye disordersMedDRA version: 13.1 Level: LLT Classification code 10067128 Term: Myopic retinal degeneration System Organ Class: 10015919 - Eye disorders
- Registration Number
- EUCTR2009-014854-14-GB
- Lead Sponsor
- ovartis Pharmaceuticals UK Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
•Written informed consent must be obtained before any assessment is performed
•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 willing and able to comply with all study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•History of any surgical intervention in the study eye within two months preceding Visit 1 (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
•Previous participation in any studies of investigational drugs within one month preceding Visit 1 (excluding vitamins and minerals)
•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
•Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/ hydroxychloroquine (Plaquenil), tamoxifen, phenothiazines and ethambutol
•Concomitant use of chronic NSAIDs for more than seven consecutive days or systemic or topical ocular corticosteroids for three or more consecutive days within six months prior to Visit 1. Note that ASA (aspirin) taken as ‘low dose’ up to 100 mg qd for prophylaxis of myocardial infarction and/or stroke is permitted during study
•Previous treatment with or participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate or corticosteroids, etc.)
•Patients who present with CNV of causes other than PM e.g. age-related macular degeneration (AMD), presumed ocular histoplasmosis, angioid streaks, multifocal choroiditis or choroidal rupture
•Ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment or macular hole (Stage 3 or 4), active intraocular inflammation (grade trace or above) or persistent macular edema due to uveitis or other inflammatory diseases
•Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period
•Planned or anticipated need for cataract surgery during the 12-month study period
•Sub or juxtafoveal laser scar in the study eye
•Vitreous haemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
•Presence of retinal pigment epithelial tear involving the macula in the study eye
•History of idiopathic or autoimmune-associated uveitis in either eye
•Active or suspected ocular, periocular or intraocular infections e.g. conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
•History of glaucoma filtration surgery or corneal surgery
•Extracapsular extraction of cataract with phacoemulsification within 2 months preceding Visit 1, or a history of post-operative complications within the last 12 months preceding Visit 1 in the study eye (uveitis, cyclitis etc.)
•Uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment w
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To provide safety and efficacy data in patients with CNV secondary to PM using a guided individualised as-needed (PRN) dosage schedule. The mean change in best-corrected visual acuity (BCVA) from Baseline to Month 12.;Primary end point(s): Change in best corrected visual acuity (BCVA) from baseline to month 12;<br> Secondary Objective: -mean change in best corrected visual acuity (BCVA) from Baseline to Month 6<br> - mean change in retinal thickness from baseline to months 6 to 12<br> - time to the first retreatment and the total number of treatments<br> - change in lesion size and morphology from screening to months 6 and 12<br> safety of intravitreal injections of ranibizumab (0.5mg) in patients with CNV secondary to PM<br>
- Secondary Outcome Measures
Name Time Method