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Completed

NCT Number: NCT01037348

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

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'.

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Key information

Conditions

Choroidal Neovascularisation Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Myopia Myopia, Degenerative Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Refractive Errors Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Bristol, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranibizumab 0.5mg

Drug

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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)

Acronym: REPAIR

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 23, 2009
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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