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Choroidal NeovascularisationPhase 2REPAIRNCT01037348

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

A Phase 2 study testing ranibizumab 0.5mg in people with Choroidal Neovascularisation, run by Novartis at 12 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Choroidal Neovascularisation
What is being tested?
ranibizumab 0.5mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
12 sitesUnited Kingdom
Study dates
Jan 2010to May 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United Kingdom12 sites

  • Novartis Investigative Site

    Bristol, BS1 2LX

  • Novartis Investigational Site

    City of London, EC1V 2PD

  • Novartis Investigative Site

    City of London, NW1 5YE

  • Novartis Investigative Site

    City of London, SE5 9RS

  • Novartis Investigative Site

    Frimley, GU16 7UJ

  • Novartis Investigative Site

    Leeds, LS9 7TF

  • Novartis Investigative Site

    Newcastle upon Tyne, NE1 4LP

  • Novartis Investigative Site

    Nottingham, NG5 1PG

  • Novartis Investigative Site

    Southampton, SO16 6YD

  • Novartis Investigative Site

    Torquay, TQ2 7AA

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP

  • Novartis Investigative Site

    York, YO31 8HE

Other trials in United Kingdom

About this study

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)

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'.

Being tested
ranibizumab 0.5mg
Keywords
Choroidal Neovascularisation, Pathological Myopia
Medical subject headings
Choroidal Neovascularization, Myopia, Degenerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ranibizumab 0.5mgDrug

Study groups in NCT01037348
Study groupRoleWhat they receive
ranibizumab 0.5mgExperimentalNot described
Receives: Drug: ranibizumab 0.5mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

Secondary outcomes (5)

  1. Mean change in BCVA from baseline

    Measured: 6 months

  2. Mean change in Central retinal Thickness (CRT) from baseline

    Measured: 6 and 12 months

  3. Percentage of patients gaining ≥ 15 letters

    Measured: 12 months

  4. Change in lesion size and morphology from baseline

    Measured: 6 and 12 months

  5. Time to the first retreatment and the total number of treatments

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01037348
Sponsor's protocol ID
CRFB002AGB10
Other IDs
2009-014854-14, 2009
Acronym
REPAIR
Status last verified
Apr 2016
First submitted
21 Dec 2009
Last updated
19 Apr 2016
Results posted
No

Publications

  • 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.

    PubMed 24001532

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ranibizumab 0.5mg in people with Choroidal Neovascularisation, run by Novartis at 12 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference from baseline in mean Best Corrected Visual Acuity (BCVA) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01037348, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.

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