Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES) - Full Text View

Sponsors and Collaborators:	Klinikum Ludwigshafen Norvartis Pharma, Nuremberg, Germany Coordination center for clinical studies, Mainz, Germany
Information provided by:	Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:	NCT00562406

Purpose

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.

Condition	Intervention
Macular Edema	Drug: Ranibizumab Procedure: Laser photocoagulation

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)

Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:

Changes in best spectacle-corrected visual acuity (BSCVA) [ Time Frame: from baseline to month 6 ]

Secondary Outcome Measures:

Mean change in BSCVA [ Time Frame: from baseline to month 3 ]
Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA [ Time Frame: from baseline to month 3 and 6 ]
Proportion of patients who lose less than 15 letters of BCVA [ Time Frame: from baseline to month 3 and 6 ]
Change in area and intensity of leakage [ Time Frame: from baseline to month 1, 3 and 6 ]
Mean change in central macular thickness (by OCT) [ Time Frame: from baseline to month 1, 3 and 6 ]
Mean change in central macular thickness (by OCT) [ Time Frame: from month 3 to 6 ]

Estimated Enrollment:	30
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
1: Active Comparator laser photocoagulation to the retina at the area of edema	Procedure: Laser photocoagulation laser photocoagulation to the retina at the area of edema
2: Experimental intravitreal injection of ranibizumab	Drug: Ranibizumab intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8 Procedure: Laser photocoagulation laser photocoagulation to the retina at the area of edema
3: Experimental laser photocoagulation to the retina at the area of edema and intravitreal injection of ranibizumab	Drug: Ranibizumab intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562406

Contacts

Contact: Alireza Mirshahi, MD, FEBO	+49 621 503 ext 3051	Mirshaha@klilu.de
Contact: Lars-Olof Hattenbach, MD	+49 621 503 ext 3051	Hattebach.lo@klilu.de

Locations

Germany
RABAMES investigational trial site	Recruiting
Ludwigshafen, Germany, 67063
Principal Investigator: Lars-Olof Hattenbach, MD
Sub-Investigator: Alireza Mirshahi, MD, FEBO
RABAMES investigational trial site	Recruiting
Freiburg, Germany
Principal Investigator: Nicolas Feltgen, MD
Sub-Investigator: Lutz L Hansen, MD, Prof.
RABAMES investigational trial site	Not yet recruiting
Munich, Germany
Principal Investigator: Siegfried Priglinger, MD
Sub-Investigator: Thomas Kreutzer, MD
Sub-Investigator: Anselm Kampik, MD, Prof.
RABAMES investigational trial site	Recruiting
Mainz, Germany
Principal Investigator: Norbert Pfeiffer, MD, Prof.
Sub-Investigator: Katrin Lorenz, MD
Sub-Investigator: Kramann Christina, MD

Sponsors and Collaborators

Klinikum Ludwigshafen

Norvartis Pharma, Nuremberg, Germany

Coordination center for clinical studies, Mainz, Germany

Investigators

Principal Investigator:

Lars-Olof Hattenbach, MD, Privatdozent

Dept. of Ophthalmology, Ludwigshafen hospital

More Information

Study ID Numbers:	AU-06104G
Study First Received:	November 21, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00562406
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Klinikum Ludwigshafen:

Macular edema secondary to branch retinal vein occlusion

Study placed in the following topic categories:

Eye Diseases
Vascular Diseases
Retinal Degeneration
Edema
Macular Degeneration
Thrombosis
Macular Edema
Signs and Symptoms

Embolism and Thrombosis
Embolism
Retinal Vein Occlusion
Neoplasm Metastasis
Venous Thrombosis
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009