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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring age-related macular degeneration, Ranibizumab

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Ophthalmology, University Medical Center Goettingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ranibizumab fixed dose

Ranibizumab on demand

Arm Description

Injection of 0.5 mg Ranibizumab every 2 months for one year, following a monthly injection during the first 3 months.

Injection of 0.5 mg Ranibizumab on demand for one year, following a monthly injection during the first 3 months.

Outcomes

Primary Outcome Measures

best-corrected visual acuity
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

Fluoresceinangiography
To study morphological and anatomical changes of the retina. Affected area is determined in mm²
Photography
To study morphological and anatomical changes of the retina. Affected area is assessed by computer-assisted measurement in mm².
optical coherence tomography (OCT)
To study morphological and anatomical changes of the retina. Thickness of the retina is determined in µm².
number of injections
quality of life
change in quality of life

Full Information

First Posted
April 11, 2013
Last Updated
April 11, 2013
Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborators
Novartis Pharmaceuticals, University Medical Center Goettingen
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1. Study Identification

Unique Protocol Identification Number
NCT01831947
Brief Title
Efficacy Study of Ranibizumab on Patients With Age-related Macular Degeneration.
Acronym
RABIMO
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborators
Novartis Pharmaceuticals, University Medical Center Goettingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
age-related macular degeneration, Ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab fixed dose
Arm Type
Experimental
Arm Description
Injection of 0.5 mg Ranibizumab every 2 months for one year, following a monthly injection during the first 3 months.
Arm Title
Ranibizumab on demand
Arm Type
Experimental
Arm Description
Injection of 0.5 mg Ranibizumab on demand for one year, following a monthly injection during the first 3 months.
Intervention Type
Biological
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis (Novartis Pharma)
Primary Outcome Measure Information:
Title
best-corrected visual acuity
Description
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).
Time Frame
12 months after start of treatment
Secondary Outcome Measure Information:
Title
Fluoresceinangiography
Description
To study morphological and anatomical changes of the retina. Affected area is determined in mm²
Time Frame
12 months after start of treatment
Title
Photography
Description
To study morphological and anatomical changes of the retina. Affected area is assessed by computer-assisted measurement in mm².
Time Frame
12 months after treatment start
Title
optical coherence tomography (OCT)
Description
To study morphological and anatomical changes of the retina. Thickness of the retina is determined in µm².
Time Frame
12 months after treatment start
Title
number of injections
Time Frame
12 months after treatment start
Title
quality of life
Description
change in quality of life
Time Frame
12 months after treatment start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dept. of Ophthalmology, University Medical Center Goettingen
City
Goettingen
ZIP/Postal Code
37075
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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