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

Primary Purpose

Choroidal Neovascularisation

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
ranibizumab 0.5mg
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Neovascularisation focused on measuring Choroidal Neovascularisation, Pathological Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigational Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ranibizumab 0.5mg

Arm Description

Outcomes

Primary Outcome Measures

The difference from baseline in mean Best Corrected Visual Acuity (BCVA)

Secondary Outcome Measures

Mean change in BCVA from baseline
Mean change in Central retinal Thickness (CRT) from baseline
Percentage of patients gaining ≥ 15 letters
Change in lesion size and morphology from baseline
Time to the first retreatment and the total number of treatments

Full Information

First Posted
December 21, 2009
Last Updated
April 15, 2016
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01037348
Brief Title
Ranibizumab for the Treatment of Choroidal Neovascularisation (CNV) Secondary to Pathological Myopia (PM): an Individualized Regimen
Acronym
REPAIR
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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'.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularisation
Keywords
Choroidal Neovascularisation, Pathological Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ranibizumab 0.5mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ranibizumab 0.5mg
Primary Outcome Measure Information:
Title
The difference from baseline in mean Best Corrected Visual Acuity (BCVA)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean change in BCVA from baseline
Time Frame
6 months
Title
Mean change in Central retinal Thickness (CRT) from baseline
Time Frame
6 and 12 months
Title
Percentage of patients gaining ≥ 15 letters
Time Frame
12 months
Title
Change in lesion size and morphology from baseline
Time Frame
6 and 12 months
Title
Time to the first retreatment and the total number of treatments
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
Facility Name
Novartis Investigational Site
City
City of London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
City of London
ZIP/Postal Code
NW1 5YE
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
City of London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Frimley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Nottingham
ZIP/Postal Code
NG5 1PG
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24001532
Citation
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.
Results Reference
derived

Learn more about this trial

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

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