Ranibizumab for the Treatment of Choroidal Neovascularisation (CNV) Secondary to Pathological Myopia (PM): an Individualized Regimen
NCT ID: NCT01037348
Last Updated: 2016-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2010-01-31
2012-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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'.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
NCT01217944
Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
NCT00275821
Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization
NCT03042871
Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
NCT01840410
Ranibizumab for Myopic Neovascularization
NCT01246089
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ranibizumab 0.5mg
ranibizumab 0.5mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ranibizumab 0.5mg
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-014854-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRFB002AGB10
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.