NCT01037348

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'.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

December 21, 2009

Last Update Submit

April 15, 2016

Conditions

Choroidal Neovascularisation

Keywords

Choroidal NeovascularisationPathological Myopia

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (5)

  • Mean change in BCVA from baseline

    6 months

  • Mean change in Central retinal Thickness (CRT) from baseline

    6 and 12 months

  • Percentage of patients gaining ≥ 15 letters

    12 months

  • Change in lesion size and morphology from baseline

    6 and 12 months

  • Time to the first retreatment and the total number of treatments

    12 Months

Study Arms (1)

ranibizumab 0.5mg

EXPERIMENTAL
Drug: ranibizumab 0.5mg

Interventions

ranibizumab 0.5mgDRUG
ranibizumab 0.5mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Novartis Investigative Site

Bristol, BS1 2LX, United Kingdom

Location

Novartis Investigational Site

City of London, EC1V 2PD, United Kingdom

Location

Novartis Investigative Site

City of London, NW1 5YE, United Kingdom

Location

Novartis Investigative Site

City of London, SE5 9RS, United Kingdom

Location

Novartis Investigative Site

Frimley, GU16 7UJ, United Kingdom

Location

Novartis Investigative Site

Leeds, LS9 7TF, United Kingdom

Location

Novartis Investigative Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Novartis Investigative Site

Nottingham, NG5 1PG, United Kingdom

Location

Novartis Investigative Site

Southampton, SO16 6YD, United Kingdom

Location

Novartis Investigative Site

Torquay, TQ2 7AA, United Kingdom

Location

Novartis Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

Location

Novartis Investigative Site

York, YO31 8HE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24001532DERIVED

MeSH Terms

Conditions

Choroidal NeovascularizationMyopia, Degenerative

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsMyopiaRefractive Errors

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 23, 2009

Study Start

January 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

GB(12)