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Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES) (RABAMES)

Primary Purpose

Macular Edema

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ranibizumab
Laser photocoagulation
Sponsored by
Klinikum Ludwigshafen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring Macular edema secondary to branch retinal vein occlusion

Eligibility Criteria

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

Inclusion Criteria:

  • Adults aged 18 years and older with chronic (> 3months, < 18 months) macular edema secondary to branch retinal vein occlusion
  • Patients who at baseline have a BSCVA in the study eye between 20/320 and equivalent to 20/40, using an ETDRS chart measured at 4 meters
  • Patients who at baseline have a chronic macular edema (> 3 months) in the study eye with the following characteristics as determined by fluorescein angiography:
  • Evidence that the macular edema extends under the geometric center of the foveal avascular zone.
  • Evidence that the edema is only secondary to BRVO (no other relevant ocular diseases, e.g. uveitis).
  • Patients who at baseline have a chronic macular edema (> 3 months) in the study eye with the following characteristics as determined by optical coherence tomography (OCT 3):
  • Evidence that central macular thickness is > 225 μm.
  • Ability of subject to understand character and individual consequences of clinical trial.
  • Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
  • For women with childbearing potential, adequate contraception (negative pregnancy test result, serum or urine at trial entry, after treatment and at end of study).
  • Only one eye of a patient may be included to this trial.

Exclusion Criteria:

  • Patients who at baseline
  • Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, neovascular age-related macular degeneration, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, and others)
  • Have a relevant systemic disease which may be associated with increased systemic VEGF levels (namely all malignancies)
  • Had previous treatment for macular edema (laser, triamcinolone, vitrectomy)
  • Pregnancy and lactation.
  • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
  • Participation in other clinical trials within the last 3 months.
  • Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
  • Arterial hypertension refractory to medical treatment

Sites / Locations

  • RABAMES investigational trial site
  • RABAMES investigational trial site
  • RABAMES investigational trial site
  • RABAMES investigational trial site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

laser photocoagulation to the retina at the area of edema

intravitreal injection of ranibizumab

laser photocoagulation to the retina at the area of edema and intravitreal injection of ranibizumab

Outcomes

Primary Outcome Measures

Changes in best spectacle-corrected visual acuity (BSCVA)

Secondary Outcome Measures

Mean change in BSCVA
Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA
Proportion of patients who lose less than 15 letters of BCVA
Change in area and intensity of leakage
Mean change in central macular thickness (by OCT)
Mean change in central macular thickness (by OCT)

Full Information

First Posted
November 21, 2007
Last Updated
July 20, 2011
Sponsor
Klinikum Ludwigshafen
Collaborators
Norvartis Pharma, Nuremberg, Germany, Coordination center for clinical studies, Mainz, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00562406
Brief Title
Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)
Acronym
RABAMES
Official Title
Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Klinikum Ludwigshafen
Collaborators
Norvartis Pharma, Nuremberg, Germany, Coordination center for clinical studies, Mainz, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this pilot study is to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
Keywords
Macular edema secondary to branch retinal vein occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
laser photocoagulation to the retina at the area of edema
Arm Title
2
Arm Type
Experimental
Arm Description
intravitreal injection of ranibizumab
Arm Title
3
Arm Type
Experimental
Arm Description
laser photocoagulation to the retina at the area of edema and intravitreal injection of ranibizumab
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8
Intervention Type
Procedure
Intervention Name(s)
Laser photocoagulation
Intervention Description
laser photocoagulation to the retina at the area of edema
Primary Outcome Measure Information:
Title
Changes in best spectacle-corrected visual acuity (BSCVA)
Time Frame
from baseline to month 6
Secondary Outcome Measure Information:
Title
Mean change in BSCVA
Time Frame
from baseline to month 3
Title
Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA
Time Frame
from baseline to month 3 and 6
Title
Proportion of patients who lose less than 15 letters of BCVA
Time Frame
from baseline to month 3 and 6
Title
Change in area and intensity of leakage
Time Frame
from baseline to month 1, 3 and 6
Title
Mean change in central macular thickness (by OCT)
Time Frame
from baseline to month 1, 3 and 6
Title
Mean change in central macular thickness (by OCT)
Time Frame
from month 3 to 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged 18 years and older with chronic (> 3months, < 18 months) macular edema secondary to branch retinal vein occlusion Patients who at baseline have a BSCVA in the study eye between 20/320 and equivalent to 20/40, using an ETDRS chart measured at 4 meters Patients who at baseline have a chronic macular edema (> 3 months) in the study eye with the following characteristics as determined by fluorescein angiography: Evidence that the macular edema extends under the geometric center of the foveal avascular zone. Evidence that the edema is only secondary to BRVO (no other relevant ocular diseases, e.g. uveitis). Patients who at baseline have a chronic macular edema (> 3 months) in the study eye with the following characteristics as determined by optical coherence tomography (OCT 3): Evidence that central macular thickness is > 225 μm. Ability of subject to understand character and individual consequences of clinical trial. Signed and dated informed consent of the subject must be available before start of any specific trial procedures. For women with childbearing potential, adequate contraception (negative pregnancy test result, serum or urine at trial entry, after treatment and at end of study). Only one eye of a patient may be included to this trial. Exclusion Criteria: Patients who at baseline Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, neovascular age-related macular degeneration, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, and others) Have a relevant systemic disease which may be associated with increased systemic VEGF levels (namely all malignancies) Had previous treatment for macular edema (laser, triamcinolone, vitrectomy) Pregnancy and lactation. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. Participation in other clinical trials within the last 3 months. Medical or psychological condition that would not permit completion of the trial or signing of informed consent. Arterial hypertension refractory to medical treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars-Olof Hattenbach, MD, Privatdozent
Organizational Affiliation
Dept. of Ophthalmology, Ludwigshafen hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
RABAMES investigational trial site
City
Freiburg
Country
Germany
Facility Name
RABAMES investigational trial site
City
Göttingen
Country
Germany
Facility Name
RABAMES investigational trial site
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
RABAMES investigational trial site
City
Mainz
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25042729
Citation
Pielen A, Mirshahi A, Feltgen N, Lorenz K, Korb C, Junker B, Schaefer C, Zwiener I, Hattenbach LO; RABAMES Study Group. Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES): six-month results of a prospective randomized clinical trial. Acta Ophthalmol. 2015 Feb;93(1):e29-37. doi: 10.1111/aos.12488. Epub 2014 Jul 8.
Results Reference
derived

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Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)

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