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Efficacy Study of Ranibizumab on Patients With Age-related Macular Degeneration. (RABIMO)

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ClinicalTrials.gov Identifier: NCT01831947
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : April 15, 2013
Sponsor:
Collaborators:
Novartis Pharmaceuticals
University Medical Center Goettingen
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Study Description
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Brief Summary:

This clinical trial investigates the impact of intravitreal injection of Ranibizumab antibody on the acuteness of vision. Patients included are suffering from choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD).

Initially, all patients get injections of 0.5 mg Ranibizumab in monthly intervals for 3 months. Subsequently, one group gets Ranibizumab in intervals of 2 months, whereas a second group is treated on demand.

The primary end point of the study is the change of best-corrected visual acuity after 12 month.

Secondary end points include the impact of Ranibizumab on morphological changes of the retina, the number of patients with gain or loss of 15 or more letters visual acuity after 12 months, changes in quality of life and the number of injections required during the first 12 months of treatment.


Condition or disease Intervention/treatment Phase
Macular Degeneration Biological: Ranibizumab Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Ranibizumab Treatment Every 2 Month Compared to Treatment on Demand on Patients With Choroidal Neo-vascularization (CNV) as a Consequence of Age-related Macular Degeneration (AMD)
Study Start Date : April 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ranibizumab fixed dose
Injection of 0.5 mg Ranibizumab every 2 months for one year, following a monthly injection during the first 3 months.
 Biological: Ranibizumab
Other Name: Lucentis (Novartis Pharma)
Experimental: Ranibizumab on demand
Injection of 0.5 mg Ranibizumab on demand for one year, following a monthly injection during the first 3 months.
 Biological: Ranibizumab
Other Name: Lucentis (Novartis Pharma)


Outcome Measures
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Primary Outcome Measures :
  1. best-corrected visual acuity [ Time Frame: 12 months after start of treatment ]
    Change of best-corrected visual acuity before and 12 months after start of treatment with respect to number of letters read on ETDRS-sheets (Early Treatment Diabetes Retinopathy Study Sheets).


Secondary Outcome Measures :
  1. Fluoresceinangiography [ Time Frame: 12 months after start of treatment ]
    To study morphological and anatomical changes of the retina. Affected area is determined in mm²

  2. Photography [ Time Frame: 12 months after treatment start ]
    To study morphological and anatomical changes of the retina. Affected area is assessed by computer-assisted measurement in mm².

  3. optical coherence tomography (OCT) [ Time Frame: 12 months after treatment start ]
    To study morphological and anatomical changes of the retina. Thickness of the retina is determined in µm².

  4. number of injections [ Time Frame: 12 months after treatment start ]
  5. quality of life [ Time Frame: 12 months after treatment start ]
    change in quality of life


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD)
  • age 50 and older, male and female
  • membrane <= 12 papillary diameter
  • visual acuity between 20/320 and 20/40 (ETDRS)
  • written informed consent

Exclusion Criteria:

  • known hypersensitivity to the medicinal product under investigation, ingredients or medicinal products with a similar chemical structure
  • participation in another clinical trial within the last 4 weeks
  • unability to understand trial information
  • pregnant or lactating women
  • women with an amenorrhea < 12 months
  • suspected unability to cooperate
  • detachment of pigment epithelium without membrane detection >= 50%,retinal angiomatotic proliferation (RAP), presumed ocular histoplasmosis syndrome (POHS), chorioretinal anastomosis (CRA), myopic CNV, CNV following trauma, uveitis, RCS or reasons except AMD
  • rupture of pigment epithelium
  • sub-retinal bleeding >= 50% of membrane or >= 1 PD
  • sub-retinal fibrosis or chorio-atrophy
  • pre-treatment with Verteporfin (photodynamic therapy), radiotherapy, trans-pupillary thermotherapy of the eye under investigation as a consequence of maculadegeneration treatment with Verteporfin of the eye not under investigation within 7 days prior inclusion
  • former participation in clinical trials with anti-angiogenic substances: Pegaptanib, Ranibizumab, Bevacizumab, Anecortave Acetat, Proteinkinase C Inhibitors
  • former injection of anti-angiogenic substances in the eye under investigation
  • former focal sub-foveal lasercoagulation of the eye under investigation
  • juxta- or extra-foveal lasercoagulation of the eye under investigation within 1 month prior inclusion
  • former vitrectomy
  • former surgery as a consequence of maculadegeneration
  • glaucoma patients which have been treated with prostaglandin containing eye drops
  • other ocular diseases which may lead to surgery within the clinical study or may lead to a loss of vision of two lines
  • acute intraocular inflammation of the eye under investigation
  • vitreous hemorrhage of the eye under investigation
  • macula-foramen of the eye under investigation
  • diabetic retinopathy
  • former retina detachment of the eye under investigation
  • uveitis
  • acute conjunctivitis, keratitis, scleritis, or endophthalmitis
  • aphakia or pseudo-aphakia with damaged back-capsule(exception: YAG-capsulotomy)
  • myopia larger than -8 diopter
  • former intra-ocular surgery of the eye under investigation within 2 months prior inclusion
  • de-compensated glaucoma with >= 30 mm Hg despite therapy
  • former filtrating glaucoma surgery of the eye under investigation
  • former corneal grafting of the eye under investigation
  • former stroke or heart attack
  • on-going therapy because of systemic infection
  • known allergic reaction to fluorescein
  • bad quality of fundus documentation because of bad range of vision
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831947


Locations
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Germany
Dept. of Ophthalmology, University Medical Center Goettingen
Goettingen, Germany, 37075
Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Novartis Pharmaceuticals
University Medical Center Goettingen
More Information
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Responsible Party: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier: NCT01831947    
Other Study ID Numbers: CRFB002ADE09T
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013
Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
age-related macular degeneration
Ranibizumab
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents