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

April 11, 2013 updated by: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Goettingen, Germany, 37075
        • Dept. of Ophthalmology, University Medical Center Goettingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Lucentis (Novartis Pharma)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months after start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoresceinangiography
Time Frame: 12 months after start of treatment
To study morphological and anatomical changes of the retina. Affected area is determined in mm²
12 months after start of treatment
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.
12 months after treatment start
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.
12 months after treatment start
number of injections
Time Frame: 12 months after treatment start
12 months after treatment start
quality of life
Time Frame: 12 months after treatment start
change in quality of life
12 months after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Collaborators

Novartis Pharmaceuticals
University Medical Center Goettingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 11, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002ADE09T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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