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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01037348
First received: December 21, 2009
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Choroidal Neovascularisation
Drug: ranibizumab 0.5mg
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The difference from baseline in mean Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in BCVA from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean change in Central retinal Thickness (CRT) from baseline [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Percentage of patients gaining ≥ 15 letters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in lesion size and morphology from baseline [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Time to the first retreatment and the total number of treatments [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: January 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ranibizumab 0.5mg Drug: ranibizumab 0.5mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037348

Locations
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
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01037348     History of Changes
Other Study ID Numbers: CRFB002AGB10, 2009-014854-14
Study First Received: December 21, 2009
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Choroidal Neovascularisation
Pathological Myopia

Additional relevant MeSH terms:
Choroidal Neovascularization
Myopia, Degenerative
Neovascularization, Pathologic
Choroid Diseases
Eye Diseases
Metaplasia
Myopia
Pathologic Processes
Refractive Errors
Uveal Diseases

ClinicalTrials.gov processed this record on October 23, 2014