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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01037348
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : April 19, 2016
Information provided by (Responsible Party):

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'.

Condition or disease Intervention/treatment Phase
Choroidal Neovascularisation Drug: ranibizumab 0.5mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: ranibizumab 0.5mg Drug: ranibizumab 0.5mg

Primary Outcome Measures :
  1. The difference from baseline in mean Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean change in BCVA from baseline [ Time Frame: 6 months ]
  2. Mean change in Central retinal Thickness (CRT) from baseline [ Time Frame: 6 and 12 months ]
  3. Percentage of patients gaining ≥ 15 letters [ Time Frame: 12 months ]
  4. Change in lesion size and morphology from baseline [ Time Frame: 6 and 12 months ]
  5. Time to the first retreatment and the total number of treatments [ Time Frame: 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01037348

United Kingdom
Novartis Investigative Site
Bristol, United Kingdom, BS1 2LX
Novartis Investigational Site
City of London, United Kingdom, EC1V 2PD
Novartis Investigative Site
City of London, United Kingdom, NW1 5YE
Novartis Investigative Site
City of London, United Kingdom, SE5 9RS
Novartis Investigative Site
Frimley, United Kingdom, GU16 7UJ
Novartis Investigative Site
Leeds, United Kingdom, LS9 7TF
Novartis Investigative Site
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Novartis Investigative Site
Nottingham, United Kingdom, NG5 1PG
Novartis Investigative Site
Southampton, United Kingdom, SO16 6YD
Novartis Investigative Site
Torquay, United Kingdom, TQ2 7AA
Novartis Investigative Site
Wolverhampton, United Kingdom, WV10 0QP
Novartis Investigative Site
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT01037348     History of Changes
Other Study ID Numbers: CRFB002AGB10
2009-014854-14 ( EudraCT Number )
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Novartis:
Choroidal Neovascularisation
Pathological Myopia

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Myopia, Degenerative
Refractive Errors
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents